Companies providing information on over 10 drug products

[BRAND-NAME DRUG COMPANY SPECIAL ORDER ]
OMB Control No. [insert]
Expires [insert]1
UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION

COMMISSIONERS:

Deborah Platt Majoras, Chairman
Pamela Jones Harbour
Jon Leibowitz
William E. Kovacic
J. Thomas Rosch

FTC Matter No. P062105

ORDER TO FILE SPECIAL REPORT
Pursuant to a resolution of the Federal Trade Commission dated March 28, 2006, entitled
“Resolution Directing The Use Of Compulsory Process,” a copy of which is enclosed, Company
A, hereinafter referred to as the “Company,” is ordered to file a Special Report with the
Commission containing the information specified herein. The enclosed Authorized Generic
Drug Study Federal Register Notice describes the purpose and scope of the information
collection.
Please supply the following information, data, and documents, consistent with the
Definitions and Instructions contained in Appendix A:
Part I

1

1.

State the full name of the Company and its official address, and its state of
incorporation.

2.

State whether the Company is a subsidiary company; whether the Company has
subsidiary companies; and report the same information specified in Item 1
regarding each parent or subsidiary engaged in research and development,
planning and design, production and manufacturing, distribution, or sales and
marketing of any drug product.

Under the Paperwork Reduction Act, as amended, an agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information unless it displays a currently
valid OMB control number.

3.

Submit one copy of each organization chart and personnel directory in effect on
January 1 of each year since January 1, 2001, (a) for the Company as a whole and,
(b) for each of the Company’s subsidiaries or divisions involved in the AG drug
business, if any.

4.

For each drug on “List A” provided by the FTC, state whether any orally
administered capsule or tablet form of the drug, at any strength, has been
marketed in the United States as an AG drug product (either currently or
previously), with a launch date after Jan. 1, 2001, under an NDA for which the
Company holds rights or held rights at the time of launch or any time thereafter.

5.

For each drug on “List B” provided by the FTC, state whether the specified
dosage form and strength of the drug has been marketed in the United States as an
AG drug product (either currently or previously), with a launch date after Jan. 1,
2001, under an NDA for which the Company holds rights or held rights at the
time of launch or any time thereafter.

6.

Submit a list of all of the Company’s orally administered prescription AG drug
products of any capsule or tablet form launched in the United States after Jan. 1,
2001 (either currently or previously marketed under a NDA for which the
Company holds or held the rights), including but not limited to the drugs on the
lists provided by the FTC, and provide the following information regarding
marketing in the United States: (a) proprietary/trade name of the AG, if any; (b)
proprietary/trade name of the brand-name drug for which the NDA authorizes the
marketing of the AG; (c) active ingredient; (d) dosage form; (e) NDA number of
the brand-name drug that authorizes the marketing of the AG (5 digits, no letter);
(f) dosage strength; (g) date of approval of the NDA for each strength; (h) the
AG’s 9-digit National Drug Code (NDC) number for each strength (labeler and
product code separated by a hyphen); (i) the date of launch for each NDC number;
(j) the date of discontinuance for each NDC number, if any; (k) the name of the
firm/business entity associated with each NDC labeler code; (l) the relationship
(or former relationship) of each labeler code firm/entity to the Company, e.g.,
current or former division, subsidiary, affiliate, licensee, contractor; (m) the
address and phone number of the firm/business entity associated with each NDC
labeler code.

7.

For each AG on the list provided by the Company in response to Item 6, state
whether the marketing entity is part of the Company, so that the Company will
coordinate with the marketing entity in providing complete answers to the
requests in Part III, Items 10, 15, 18, 21, 24, 27, 28, and 30 below or whether the
marketing entity is not part of the Company, so that the FTC will need to contact
the AG marketing entity identified in Item 6(k).
2

Part II
8.

Submit to the FTC by Jan. 31, 2008 a list of any additional AGs launched in the
United States by Dec. 31, 2007 and the information requested in Item 6.

9.

For changes in the information provided to the FTC in response to Item 6 that
occur by Dec. 31, 2007, submit updated information to the FTC by Jan. 31, 2008.
Part III

10.

For each AG drug on the list the Company provided to the FTC in response to
Item 6, state the date of the first public announcement of the marketing or
intended marketing of the AG in the United States.

11.

For each AG drug on the list the Company provided to the FTC in response to
Item 6, state whether marketing of the AG occurred pursuant to a litigation
settlement agreement between the Company and an ANDA-generic company, or
whether at any time the Company entered into a litigation settlement agreement
not to market the AG or to market it after a specified date more than 30 days after
execution of the agreement. If so, state the names of the parties, court, case
number, date that the litigation was filed, and the date of the settlement
agreement.

12.

For each brand-name drug on the list the Company provided to the FTC in
response to Item 6(b) (brand-name versions of AGs), provide the following
information in regard to marketing in the United States: (a) proprietary/trade
name of the brand-name drug; (b) active ingredient; (c) dosage form; (d) NDA
number (5 digits, no letter); (e) dosage strength; (f) date of approval of the NDA
for each strength; (g) the 9-digit National Drug Code (NDC) number for each
strength (labeler and product code separated by a hyphen); (h) the name of the
firm/business entity associated with each NDC labeler code; (i) the relationship
(or former relationship) of each labeler code firm/entity to the Company, e.g.,
Company, predecessor company, current or former division, subsidiary, affiliate,
licensee, contractor; (j) therapeutic category; (k) pharmacological class; (l) 14digit GPI (Medi-Span’s Generic Product Identifier); (m) date of entry by the first
competing ANDA-generic drug; (n) whether the first ANDA-generic entry
occurred pursuant to a 180-day exclusivity period, and if so, provide (o) the names
of all ANDA-generic companies that entered during such exclusivity.

13.

For all strengths of brand-name drugs on “List B” that were not covered in the
response to Item 12 (i.e., brand-name drugs for which no AG was marketed),
provide the information requested in Item 12.

3

14.

For all strengths of brand-name drugs on “List B” listed in the response to Item 13
(i.e., brand-name drugs for which no AG was marketed), state whether a litigation
settlement agreement between the Company and an ANDA-generic company
provided that an AG would not be marketed. If so, state the names of the parties,
court, case number, date that the litigation was filed, and the date of the settlement
agreement.

15.

Sales of AG drugs, by NDC. For each AG drug in the list the Company provided
to the FTC in response to Item 6, for sales in the United States from Jan. 1, 2001March 31, 2007, state the (a) applicable month and year; (b) the drug identifying
information described in the second paragraph of Instruction (D); (c) the AG’s 11digit NDC number (including labeler, product, and package size codes separated
by hyphens); (d) package size; (e) package type; total monthly sales to all
customers, net of discounts, rebates, promotions, returns and chargebacks, in (f)
units (as represented by the NDC’s package size code), and in (g) dollars.

16.

Sales of brand-name drugs (AG version marketed), by NDC. For each brandname drug on the list the Company provided to the FTC in response to Item 12
(brand-name versions of AGs), for sales in the United States from Jan. 1, 2001March 31, 2007, state the (a) applicable month and year; (b) the drug identifying
information described in the second paragraph of Instruction (D); (c) 11-digit
NDC number (including labeler, product, and package size codes separated by
hyphens); (d) package size; (e) package type; total monthly sales to all customers,
net of discounts, rebates, promotions, returns and chargebacks, in (f) units (as
represented by the NDC’s package size code), and in (g) dollars.

17.

Sales of brand-name drugs (no AG version marketed), by NDC. For all brandname drugs on “List B” that were not covered in the response to Item 16 (i.e.,
brand-name drugs listed in response to Item 13, for which no AG was marketed),
provide the information requested in Item 16.

18.

Total sales/revenues from AG drugs. For each AG drug in the list the Company
provided to the FTC in response to Item 6, for sales in the United States from Jan.
1, 2001-March 31, 2007, state the (a) applicable month and year; (b) the drug
identifying information described in the second paragraph of Instruction (D); (c)
the Company’s total monthly sales/revenues attributable to all strengths and
package sizes of the dosage form under consideration, net of discounts, rebates,
promotions, returns and chargebacks, in dollars; and (e) the total monthly sales in
prescriptions.

19.

Total sales: brand-name drugs (AG version marketed). For each brand-name
drug on the list the Company provided to the FTC in response to Item 12 (brandname versions of AGs), for sales in the United States from Jan. 1, 2001-March 31,
4

2007, state the (a) applicable month and year; (b) the drug identifying information
described in the second paragraph of Instruction (D); (c) the Company’s total
monthly sales attributable to all strengths and package sizes of the dosage form of
the brand-name drug under consideration, net of discounts, rebates, promotions,
returns and chargebacks, in dollars; and (d) the total monthly sales in
prescriptions.
20.

Total sales: brand-name drugs (no AG marketed). For all brand-name drugs on
“List B” that were not covered in the response to Item 19 (i.e., brand-name drugs
listed in response to Item 13, for which no AG was marketed), provide the
information requested in Item 19.

21.

Prices of AG drugs: WAC and AWP. For each AG drug in the list the Company
provided to the FTC in response to Item 6, for sales in the United States from Jan.
1, 2001-March 31, 2007, state the (a) applicable month and year; (b) the drug
identifying information described in the second paragraph of Instruction (D); (c)
the AG’s 11-digit NDC number (including labeler, product, and package size
codes separated by hyphens); (d) package size; (e) package type; (f) wholesale
acquisition cost (“WAC,” see 42 U.S.C. § 1395-3a(b)(6)(B)); and (g) the average
wholesale price (“AWP”).

22.

Prices of brand-name drugs (AG version marketed): WAC and AWP. For each
brand-name drug on the list the Company provided to the FTC in response to Item
12 (brand-name versions of AGs), for sales in the United States from Jan. 1, 2001March 31, 2007, state the (a) applicable month and year; (b) the drug identifying
information described in the second paragraph of Instruction (D); (c) 11-digit
NDC number (including labeler, product, and package size codes separated by
hyphens); (d) package size; (e) package type; (f) WAC; and (g) the AWP.

23.

Prices of brand-name drugs (no AG marketed): WAC and AWP. For all brandname drugs listed in the response to Item 13 that have been subject to ANDAgeneric competition (i.e., brand-name drugs for which a date of ANDA-generic
entry was entered in Item 13(m)), provide the information requested in Item 22
(for the period from Jan. 1, 2001-March 31, 2007).

24.

Prices of AG drugs: AMP. For each AG drug in the list the Company provided to
the FTC in response to Item 6, for sales in the United States from Jan. 1, 2001March 31, 2007, state the (a) applicable quarter and year; (b) the drug identifying
information described in the second paragraph of Instruction (D); (c) the AG’s 9digit NDC number (including labeler and product codes separated by a hyphen);
and (d) the average manufacturer price (“AMP”) as defined by, and reported to,
the Centers for Medicare and Medicaid Services (CMS).

5

25.

Price of brand-name drugs (AG version marketed): AMP. For each brand-name
drug on the list the Company provided to the FTC in response to Item 12 (brandname versions of AGs), for sales in the United States from Jan. 1, 2001-March 31,
2007, state the (a) applicable quarter and year; (b) the drug identifying information
described in the second paragraph of Instruction (D); (c) 9-digit NDC number
(including labeler and product codes separated by a hyphen); and (d) the AMP as
defined by, and reported to, the CMS.

26.

Prices of brand-name drugs (no AG marketed): AMP. For all brand-name drugs
listed in the response to Item 13 that have been subject to ANDA-generic
competition (i.e., brand-name drugs for which a date of ANDA-generic entry was
entered in Item 13(m)), provide the information requested in Item 25 (for the
period from Jan. 1, 2001-March 31, 2007).

27.

Submit all documents that were prepared by or for any officer(s) or director(s) of
the Company and/or, if applicable, the marketing entity, or that are in the files of
any current or prior Company (and/or marketing entity) senior vice president (or
equivalent position) with product line responsibility (during all or part of the period
from January 1, 2003-April 3, 2006) for an AG and/or a brand-name drug in the list
the Company provided to the FTC in response to Item 6 (or, in the case of
unincorporated entities, individuals exercising similar functions), as follows. (a)

For each AG/brand-name pair identified in the list the Company provided to the
FTC in response to Item 6, submit planning, decisional, or strategy documents
prepared from Jan. 1, 2002 to April 3, 2006, including studies, surveys, analyses,
and reports (both internal and external), that evaluated, considered, or analyzed (but
did not merely refer to) the marketing or possible marketing of an AG or AGs (as a
response to current or future generic competition or for other reasons), including
but not limited to whether or not to license or otherwise market a brand-name drug
product as an AG drug product; reasons for marketing an AG and/or refraining
from marketing an AG; the timing of AG launch relative to a 180-day exclusivity
period; the marketing of an AG during 180-day exclusivity; the marketing of an AG
in the context of paragraph IV certifications and settlements of litigation; the
marketing of AGs upon expiration of patents or marketing exclusivities claiming a
brand-name drug product or its use; and the profitability or other benefits of
marketing an AG drug. (b) With respect to AGs in general, submit documents as

described in (a) of this Item.
28.

For each AG drug identified in the list the Company provided to the FTC in
response to Item 6, submit copies of any public announcements, e.g., press
release(s) of the planned marketing or launch of the AG in the United States.

29.

If the Company licensed or otherwise authorized the marketing by another entity of
an AG drug product in the list the Company provided to the FTC in response to
Item 6, submit the agreement that authorized marketing (including agreements

6

between the Company and any business entity acquired after the agreement was
executed).
30.

Submit planning, decisional, or strategy documents dated Jan. 1, 2006-April 29,
2007 that discuss the effect(s) or possible effect(s) of the enactment of Section 6003
of the Deficit Reduction Act of 2005, P.L. 109-171,2 on the marketing of AGs after
Jan. 1, 2007.

By direction of the Commission.
Deborah Platt Majoras
Chairman
SEAL

Date of Order:

2

Section 6003 of the Deficit Reduction Act of 2005, P.L. 109-171, which became effective on
Jan. 1, 2007, amends Section 1927(b)(3)(A) of the Social Security Act (42 U.S.C.
§ 1396r–8(b)(3)(A)) to include all drugs approved pursuant to 21 U.S.C. § 355(c), including
AGs, in Medicaid best price calculations.
7

APPENDIX A
GENERAL INSTRUCTIONS
A.

Organization of Responses and Due Dates of Parts

The Special Report consists of three parts, a Preliminary Report as specified in Part I,
which must be filed by [date], or within 30 days of receipt of this Special Order, whichever is
later; an Updated Preliminary Report as set forth in Part II, which must be filed by Jan. 31, 2008;
and a Detailed Report as set forth in Part III, which must be filed by [date-90 days of receipt].
B.

Responses to Questions

The Special Report should be entered into the Excel spreadsheets provided with this
Order whenever possible. The FTC has entered the question numbers and the information that
must be provided in the header row of each column. To efficiently enter the requested
information, companies may wish to electronically “copy and paste” drug identifying or other
information that must be entered on more than one row or worksheet. When it is not possible to
enter the required answer or information into the applicable worksheet, or no worksheet has been
provided, restate the Item and provide the required answer or information. If any question cannot
be answered fully, give the information that is available and explain in detail in what respects and
why the answer is incomplete.
All responses to Items 1-2 and 4-13 should be submitted to the FTC in both paper and in
electronic form (as Excel, Word, or WordPerfect documents) on machine-readable CDs or
DVDs.
C.

DEFINITIONS

The following definitions apply to all Items:
(1)

“Active ingredient” means a drug’s nonproprietary established name, including the
established names for all active ingredients, as defined at 21 C.F.R. § 299.4 and used in
the Orange Book.3

(2)

“ANDA” means Abbreviated New Drug Application, as set forth in 21 U.S.C. § 355(j).

(3)

“ANDA-generic drug” means a drug marketed or sought to be marketed pursuant an
approved ANDA and usually sold under the established name of the active ingredient(s).

3

See FDA, APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUA TIONS v, 2-2
(27th ed. 2007) [hereinafter Orange Book].
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(4)

“Authorized generic (“AG”) drug” means any drug sold, licensed or marketed under an
NDA approved by the FDA under 21 U.S.C. § 355(c); and marketed, sold or distributed
(directly or indirectly) without using the listed drug’s brand-name and with a different
NDC product number or labeler number (or both).4

(5)

“Brand-name” drug means an innovator drug product marketed pursuant to an approved
NDA under a proprietary, trademark-protected name.

(6)

“Capsule” means all dosage forms of capsules as set forth in Appendix C of the Orange
Book, including capsule; capsule, delayed release (DR); capsule, delayed release pellets
(DRP); and capsule, extended release (XR).

(7)

“Company” means Company A, its domestic and foreign parents, predecessors, divisions,
subsidiaries, affiliates, partnerships and joint ventures, and all directors, officers,
employees, agents and representatives of the foregoing. The terms “subsidiary”,
“affiliate” and “joint venture” refer to any person in which there is partial (50 percent or
more) or total ownership or control between the company and any other person. As used
in this definition, the term “person” includes the company and means any natural person,
corporate entity, partnership, association, joint venture, government entity, or trust.

(8)

“Documents” means all computer files and written, recorded, and graphic materials of
every kind in the possession, custody or control of the Company.

(9)

“NDA” means a New Drug Application, as set forth in 21 U.S.C. § 355(b) and approved
under 21 U.S.C. § 355(c).

(10)

“Tablet” means all dosage forms of tablets as set forth in Appendix C of the Orange
Book, including tablet; tablet, chewable (C); tablet, coated particles (CP); tablet, delayed
release (DR); tablet, delayed release, orally disintegrating (DR OD); tablet, extended
release (XR); tablet, orally disintegrating (OD).

4

Generally, AGs are marketed under a different product code, labeler code, trade name,
trademark, and/or packaging (other than repackaging the listed drug for use in institutions) than
the listed drug. See Medicaid Program; Prescription Drugs, 71 Fed. Reg. 77,174, 77,183-84,
77,198 (Dec. 22, 2006). Typically, the name of an AG is the nonproprietary established name of
its active ingredients, but in some cases a trade name different from the brand-name of the listed
drug is used. Also, AGs are usually marketed by a subsidiary or division of the brand-name
manufacturer or a third party in a manner equivalent to the marketing practices of holders of an
approved ANDA for a drug. See Letter from William K. Hubbard, FDA, to Stuart A. Williams,
Mylan Pharmaceuticals, Inc., and James N. Czaban, Heller Ehrman White & McAuliffe 2 n.2
(July 2, 2004) (responding to the citizen petitions of Mylan and Teva regarding AG drugs and
180-day exclusivity).
9

D.

Data Submissions

Unless modified by agreement in writing with the staff of the Federal Trade Commission,
all numerical data submitted in response to Items 15-26 must be submitted in a spreadsheet
format both on paper and on machine-readable CDs or DVDs. The Commission will accept
database and spreadsheet data in the following formats: MS Excel, MS Access, tab-delimited or
fixed width text files. All financial information required to be submitted by this Order should be
in whole dollar amounts. For Items 15-26, the applicable month (quarter) and year requested
refers to each month and year for which the Company provides the information called for by the
given Item. If the information is not kept in the form requested, the Company is encouraged to
contact the Commission representative to discuss alternative formats in which the information
may be provided.
To identify the drug for which data is being provided, for those Items requesting data on
AGs (Items 15, 18, 21, and 24) state on the applicable row or page the (b)(1) proprietary/trade
name of the AG, if any; (b)(2) proprietary/trade name of the brand-name drug; (b)(3) active
ingredient; (b)(4) dosage form; (b)(5) NDA number (5 digits, no letter); and the (b)(6) dosage
strength (except for Item 18). For Items requesting data on brand-name drugs (Items 16-17, 1920, 22-23, and 25-26), state the previously listed identifying information (b)(1)-(6), omitting (6)
for Items 19 and 20.
E.

Document Submissions

This Special Order covers documents in the Company’s possession, custody or control,
wherever the documents are located. However, unless or until the Commission notifies
Company otherwise in writing, the Commission will not seek to enforce the Special Order to
compel the production of documents that were located outside the United States at the time
Company received the Special Order. In order to expedite the receipt of documents reflecting the
views of all recipients of Special Orders, the Commission requests your cooperation in producing
any such documents on a voluntary basis by the date specified in this Special Order.
Provide two paper copies of each document. All documentary responses should be Batesstamped.
F.
1.

Responsibilities of Company and AG-Marketing Entity Officials

Companies that market AGs via entities that are part of the Company as defined in
definition (7) are required to coordinate with those marketing entities in the submission of
certain information on AGs in Part III, as described in the instructions to individual Items.
If the marketing entity identified in Item 6(k) is not part of the Company, the FTC will
also contact the marketing entity, and require it to submit certain information on the AGs
it markets. The Company’s response to Item 7 merely notifies the FTC, on a drug-bydrug, entity-by-entity basis, whether the Company will contact the marketing entity and
10

coordinate with it, because it is part of the Company or whether the FTC will contact the
marketing entity, because the marketing entity is not part of the Company. For most
Items, however, the Company and any independent marketing entity (which the FTC will
contact separately) will be required to respond. The Company’s response to Item 7 does
NOT eliminate the Company’s requirement to respond to each Item, unless expressly
stated in the instructions for an Item.
2.

The Special Report is required to be subscribed and sworn to by an official of the
Company who has prepared or supervised the preparation of the Special Report from
books, records, documents, correspondence, and other data and material in the
Company’s possession. In addition, if the Company indicates in response to Item 7 that it
will coordinate with its AG marketing entity, then Items 10, 15, 18, 21, 24, 27-28, and 30
must be subscribed and sworn to by an official of the subsidiary, or other entity of the
Company that markets AGs. Each subscriber to the Special Report is to give his or her
full name, title, and contact information in a notarized certification at the end of the
Special Report, as set forth in Appendix B.
G.

Questions

Any questions you have relating to the scope or meaning of this Order, or suggestions for
possible modifications thereto, should be directed to Karen A. Goldman, Federal Trade
Commission, Office of General Counsel, 600 Pennsylvania Ave., N.W., Washington, DC 20580,
(202) 326-2574, kgoldman@ftc.gov.
H.

Submission of Report

The Special Report must be Bates-stamped.
You are advised that penalties may be imposed under applicable provisions of federal law
for failure to file Special Reports or for filing false reports.
Two copies of the Special Report shall be filed with the Secretary, Federal Trade
Commission, Room H-159, 600 Pennsylvania Ave., NW, Washington, DC 20580 by 5:00 PM on
the dates specified herein.

INSTRUCTIONS FOR SPECIFIC ITEMS
Part I
1-3.

Self-explanatory.

11

4.

To facilitate the Company’s response, the FTC has provided two lists of drugs marketed
by the Company in the United States during the relevant time frame. “List A” is a list of
drugs for which the available information indicates that an AG was launched by the
Company, or with its authorization, after Jan. 1, 2001 (a blank list will be provided if the
FTC is not aware of any AGs). Using the Excel spreadsheet containing List A, confirm
that at least one orally administered capsule or tablet form of each drug has been
marketed as an AG by entering “yes” in the applicable column. If the Company believes
that no orally administered capsule or tablet form of the drug has been marketed as an
AG, enter “no.”

5.

“List B” is a list of the Company’s orally administered capsule and tablet dosage forms of
drugs for which at least one ANDA with a paragraph IV certification was filed and
generic competition began after Jan. 1, 2001, or for which generic competition has not yet
begun and at least one ANDA with a paragraph IV certification was filed after Jan. 1,
2001. The list contains only those strengths for which a paragraph IV certification has
been made. Some of the drugs on List B may also appear on List A. Using the Excel
spreadsheet containing List B, enter “yes” if a particular strength of a drug has been
marketed as an AG in the United States, or “no” if it has not.

6.

The Company’s response to this Item must include all orally administered AGs of any
capsule or tablet dosage form launched in the United States after Jan. 1, 2001, for which
the Company holds rights to the NDA under which the AG is marketed, or held rights to
the NDA when the AG was launched or any time thereafter, regardless of whether the AG
is currently marketed by the Company. The response must address, but is not limited to,
the drugs on the lists provided by the FTC. Thus, the Company’s response must include
all orally administered capsule or tablet dosage forms of its AGs, regardless of whether
the drug was on either List A or List B, or whether the corresponding brand-name drug
was subject only to paragraph I, II, or III certifications.
Enter the list of the Company’s AG drugs and the required information for each on the
spreadsheet provided by the FTC. Enter the specific dosage form, e.g., capsule DR,
capsule XR, tablet DR, or tablet XR. Enter each strength for each dosage form on a
different row. If more than one entity marketed a particular drug, use different rows to
enter the information for each entity.
Item 6(h), (k), (m). The response to Item 6(h) should include all 9-digit NDC numbers
used in the direct or indirect marketing, sale, or distribution of the AG in the United
States, whether by the Company or by other entities, e.g., licensees under the Company’s
NDA. Thus, Item 6(k) should provide a complete list of entities that market the AG,
whether the marketing entity is part of the Company or independent of it. Do not,
however, include NDC numbers that cover repackaged or relabeled drug products (such
as those for use in institutions) that were previously sold under one of the aforementioned
NDCs. If the NDCs associated with the AG have changed, e.g., due to marketing by
12

different business entities, provide all NDC numbers that have been used. If there are
multiple NDC numbers for a given strength, each should be entered on a different row.
The address and phone number of the firm/business entity that markets the AG (requested
in Item 6(m)) need only be entered the first time that the name of the entity is provided in
response to Item 6(k).
7.

If an AG is marketed via an entity that is part of the Company as defined in definition (7),
the Company must enter “yes” on the applicable spreadsheet column, and it is required to
coordinate with the marketing entity in the submission of information on that AG. If an
AG is marketed by an entity that is not a part of the Company, such as a contractor or
licensee, the Company must enter “no,” and the marketing entity will be contacted by the
FTC and asked to provide certain information. A Company’s response of “no” to Item 7
does NOT eliminate the Company’s requirement to respond to each Item below, unless
expressly stated in the instructions for an Item.
Because some manufacturers of brand-name pharmaceuticals also manufacture ANDAgeneric drugs, the FTC reserves the right to request additional information from the
Company, and directly from marketing entities that are part of the Company, even if the
Company has responded to this request or provided a coordinated response to an Item.
Part II

8.

This Item requests the basic information in Item 6 on any AGs launched in the United
States by Dec. 31, 2007 pursuant to a NDA for which the Company holds rights, that
were not included in the Company’s initial response to that Item. For the purposes of this
study, the FTC will not require any information beyond that requested in Item 6 for these
AGs.

9.

This Item requests updated information on AGs identified by the Company in its initial
response to Item 6, including but not limited to, whether the marketing of the AG has
been discontinued or otherwise changed (e.g., dosage form or strength, marketing entity).
Part III

10.

On the applicable spreadsheet and column, enter the date of the first public announcement
by any entity, including but not limited to announcements made by the Company, of the
intended marketing of each AG. Documentation of the first announcement is requested in
Item 28.

11.

On the applicable spreadsheet and column, enter “yes” if the marketing of the AG
occurred pursuant to a settlement agreement, or if the Company entered into a settlement
agreement not to market the AG or to market it after a specified date more than 30 days
13

after execution of the agreement; enter “no” if there were no such agreements. If “yes,”
restate Item 11 on a separate document, identify the AG, and provide the required
information about the litigation.
12.

For identification and informational purposes, Item 12(a)-(f) repeats information provided
in Item 6(b)-(g). Each strength should be listed in a separate row, followed by the rest of
the requested information. If there are multiple NDC numbers for a given strength, each
should be entered in a different row.
Item 12(j), (k). State the therapeutic category and pharmacological class as set forth in
the U.S. Pharmacopeial Convention, Inc., U.S.P. Medicare Model Guidelines, Version 2,
Feb. 6, 2006.5
Item 12(l). When entering the 14-digit GPI, separate the two-digit fields with dashes.
Items 12(m), (n), (o). If the brand-name drug has not been subject to ANDA-generic
competition, enter “none” in response to Item 12(m), and do not respond to Items 12(n)
and (o).

13.

Enter the required information for each brand-name drug on “List B” that was not
covered in the response to Item 12 on the spreadsheet provided by the FTC. Enter the
specific dosage form, e.g., capsule DR, capsule XR, tablet DR, or tablet XR. Enter each
strength, and each 9-digit NDC number related to a particular strength, in a different row.
If the NDCs associated with the drug have changed, provide all NDC numbers that have
been used. With respect to therapeutic category and pharmacological class, follow the
instructions in Item 12. If the brand-name drug has not been subject to ANDA-generic
competition, enter “none” in response to Item 13(m), and do not respond to Items 13(n)
and (o).

14.

On the applicable spreadsheet and column, enter “yes” if a litigation settlement agreement
between the Company and an ANDA-generic company provided that an AG would not be
marketed, and if not, enter “no.” If “yes,” restate Item 14 on a separate document,
identify the drug, and provide the required information about the litigation.

15.

Item 15 requests monthly net sales data for AGs for all 11-digit NDCs arising from the 9digit NDCs provided in response to Item 6(h), i.e., including all package size codes for
those NDCs.
If the Company answered “yes” to Item 7 with respect to a particular drug, the Company
must coordinate with its marketing entity in providing the information requested in Item
15. If the Company is not coordinating with its marketing entity with respect to a

5

See http://www.usp.org/pdf/EN/mmg/modelGuidelinesV2.0-2006-02-06.pdf . See also Drug
List Table, at http://www.usp.org/pdf/EN/mmg/drugListingV2.0-2006-02-06.pdf .
14

particular drug, i.e., it answered “no” in response to Item 7 for that drug, the Company
should only submit data for Items 15(a)-(f). In such cases, the FTC will ask the
marketing entity to provide the information requested in Items 15(g).
16.

Include sales for each strength provided in response to Item 12(e). Thus, the response to
Item 16 should include sales for all 11-digit NDC codes arising from the 9-digit codes
provided in response to Item 12(g).

17.

Include sales for all 11-digit NDC codes arising from the 9-digit codes provided in
response to Item 13.

18.

Responses to this Item represent the Company’s combined sales or revenues from all
strengths and NDC numbers.
If the Company answered “yes” to Item 7 with respect to a particular drug, the Company
must coordinate with its marketing entity and provide the net sales for the Company
(including the marketing entity) with respect to that drug. However, the Company must
respond to Item 18 even if the Company answered “no” to Item 7 and is not coordinating
with the marketing entity. In such cases, the Company should provide its revenues
(including royalties, license fees, and transfer payments) arising from sales in the United
States, not the sales of the independent marketing entity. In calculating its net revenues,
the Company should include its own discounts, rebates, promotions, returns and
chargebacks (if any), not those of the independent marketing entity.

19, 20. Responses to these Items represent the Company’s combined sales from all strengths and
NDC numbers.
21.

The referenced 11-digit NDCs should have been listed in response to Item 15(c).

22.

The referenced 11-digit NDCs should have been listed in response to Item 16(c).

23.

The 11-digit NDCs should be a subset of those listed in response to Item 17. Provide data
for the entire requested period, regardless of whether the drug was subject to ANDAgeneric competition for the entire time.

24.

Item 24 requests the quarterly Average Manufacturer Price (“AMP,” see 42 U.S.C.
§ 1396r-8(k)(1)), for each AG listed by the Company in response to Item 6, for all 9-digit
NDCs provided in response to Item 6(h).
If the Company answered “yes” to Item 7 with respect to a particular drug, the Company
must coordinate with its marketing entity in providing the information requested in Item
24. If the Company is not coordinating with its marketing entity with respect to a
particular drug, i.e., it answered “no” in response to Item 7 for that drug, the Company
15

should not respond to this Item. In such cases, the FTC will ask the independent
marketing entity to provide the AMP.
25.

The Company must provide the information requested in Item 25, regardless of its
response to Item 7 and whether it is coordinating with the marketing entity.

26.

The 11-digit NDCs should be those listed in response to Item 23. Provide data for the
entire requested period, regardless of whether the drug was subject to ANDA-generic
competition for the entire time.

27.

When responding to Item 27(b), do not duplicate documents provided in response to Item
27(a).
If the Company answered “yes” to Item 7 with respect to a particular drug, the Company
must coordinate with its marketing entity in responding to Item 27(a) with respect to that
drug. In responding to Item 27(b) in regard to documents generally about AG drugs, the
Company must coordinate with its marketing entity if it answered “yes” to Item 7 with
respect to any drug. However, the Company must respond to Items 27(a) and 27(b) even
if it answered “no” in response to Item 7 and is not coordinating with the marketing
entity. In such cases, the marketing entity will be asked to respond to Items 27(a) and
27(b), in addition to the Company.
Group the documents by drug product, and if applicable, segregate the documents obtained
from the Company from the documents obtained from the marketing entity. For each
document, indicate the name of the person from whose files the document came and

whether the document was generated within the Company or externally; if generated
externally, provide the name of the source of the document.
28.

If the Company answered “yes” to Item 7 with respect to a particular drug, the Company
must coordinate with its marketing entity in responding to this Item with respect to that
drug. Group the documents by drug product.

29.

The Company must respond to Item 29 with respect to all AGs for which the Company
answered “no” in response to Item 7, and is not coordinating with the marketing entity.
Group the documents by drug product, and indicate the name of the person from whose
files the document came.
If an agreement authorizing the marketing of an AG was previously submitted to the FTC
pursuant to the Medicare Prescription Drug, Improvement, and Modernization Act of
2003,6 do not provide another copy of the agreement. Provide the names of the parties,
the date of the agreement, and the date that the agreement was submitted to the FTC.

6

See P.L. 108-173 , tit. XI, Subtit. B, § 1112, 11 7 Stat. 2066, 2461-2 (20 03).

16

30.

The Company must respond to this Item, and if the Company answered “yes” to Item 7
with respect to any drug, the Company must coordinate with its marketing entity in
responding to this Item. For each document, indicate the name of the person from whose
files the document came.

17

APPENDIX B
Certification
This Special Report, together with any and all appendices and attachments thereto, was
prepared and assembled under my supervision in accordance with instructions issued by the
Federal Trade Commission in its Special Orders for the Authorized Generic Drug Study.
Subject to the recognition that, where so indicated, reasonable estimates have been made
because books and records do not provide the required information, the information is, to the
best of my knowledge, true, correct, and complete. Where copies rather than original documents
have been submitted, the copies are true, correct, and complete.

TYPE OR PRINT NAME AND TITLE

TYPE OR PRINT COMPANY NAME AND ADDRESS

TYPE OR PRINT PHONE NUMBER AND E-MAIL ADDRESS

(Signature)
Subscribed and sworn to before me at the City of
State of
of

, this
, 20

day

.

(Notary Public)
My Commission Expires:

18

,