Form FDA 3542 Form FDA 3542 Patent Information Submitted Upon and After Approval of

Form Approved: OMB No. 0910-0513
Expiration Date: xx/xx/xxxx
See OMB Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

PATENT INFORMATION SUBMITTED UPON AND
AFTER APPROVAL OF AN NDA OR SUPPLEMENT
For Each Patent That Claims a Drug Substance
(Active Ingredient), Drug Product (Formulation or
Composition) and/or Method of Use

NDA Number
Name of NDA Holder

Refer to instruction sheet (Form FDA 3542 Supplement) for more information.
The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
Trade Name

Active Ingredient(s)

Dosage Form(s)

Strength(s)

Route(s) of Administration

Type of Use
Prescription

Over-the-Counter

Approval Date of NDA or Supplement to which patent information relates (Enter date, and select either NDA or Supplement.)
NDA

Supplement

This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) within thirty (30) days after the
date of approval of an NDA or supplement or within thirty (30) days of issuance of a patent as required by 21 CFR 314.53(c)(2)(ii)
at the address provided in 21 CFR 314.53(d)(4). Except as provided in 21 CFR 314.53(f)(1), a patent declaration form containing an
amendment to the description of the approved method(s) of use claimed by the patent is required to be submitted to FDA within thirty
(30) days of patent issuance, within thirty (30) days of approval of a corresponding change to product labeling, or within thirty (30) days
of a decision described in 21 CFR 314.50(i)(4)(i)(C) or 314.94(a)(12)(vi)(A)(3).
FDA will not list patent information if the patent declaration does not contain the information required by 21 CFR § 314.53(c)(2)
or the patent declaration indicates the patent is not eligible for listing.

For each patent submitted for the approved NDA or supplement referenced above, you must submit the information
described below. If you are not submitting any patents for this NDA or supplement, complete the section above and sections
5 and 6.

1. GENERAL (Please note: If 1.a is NOT entered, then section 5 later in form must be marked as “Yes” in its check box.)
a. United States Patent Number

b. Issue Date of Patent

c. Expiration Date of Patent

d. Name of Patent Owner
Address (of Patent Owner)
State/Province/Region
FAX Number (if available)

City
Country

ZIP or Postal Code

Telephone Number

E-Mail Address (if available)

Click for additional set of 1.d. entries (includes all address and related contact items above). May be repeated.

FORM FDA 3542 (8/16)

Page 1 of 5

Add Section 1.d.

PSC Publishing Services (301) 443-6740

EF

e. Name of agent or representative who resides or
maintains a place of business within the United
States authorized to receive notice of patent
certification under section 505(b)(3) and (j)(2)(B) of
the Federal Food, Drug, and Cosmetic Act and 21
CFR 314.52 and 314.95 (if patent owner or NDA
holder does not reside or have a place of business
within the United States)
Name:

Address (of agent or representative named in 1.e.)
City/State
ZIP Code

FAX Number (if available)

Telephone Number

E-Mail Address (if available)

Click for additional set of 1.e. entries (includes all address and related contact items above). May be repeated.

Add Section 1.e.

f. Name of NDA Holder
Address (of NDA Holder)

City

State/Province/Region
FAX Number (if available)

Country

ZIP or Postal Code

Telephone Number

E-Mail Address (if available)

g. Has the patent referenced above been submitted previously for listing for this drug
product?

Yes

No

h. If the answer to question 1.g. is “Yes,” identify all change(s) from the previously submitted Form 3542 and specify whether
each change is related to the patent or related to an FDA action or procedure.

For the patent referenced above, provide the following information on whether the patent claims the drug substance, drug
product, or method of use that is the subject of the approved NDA or supplement. FDA will not list patent information if the
patent declaration does not contain the information required by 21 CFR § 314.53(c)(2) or the patent declaration indicates
the patent is not eligible for listing.
• If the patent is eligible for listing as claiming the drug substance and section 2 is completed, it is not necessary to
complete section 3 even if the patent also is eligible for listing as claiming the drug product.
• If the patent is eligible for listing as claiming the drug product and section 3 is completed, it is not necessary to
complete section 2 even if the patent also is eligible for listing as claiming the drug substance.
FDA will consider incomplete a patent declaration that does not include a response to all required questions contained
within each section below applicable to the patent referenced above.

2. DRUG SUBSTANCE (ACTIVE INGREDIENT)
2.1
2.2
2.3

Does the patent claim the drug substance that is the active ingredient in the drug
product described in the approved NDA or supplement? If yes, skip to Question 2.5.

Yes

No

Does the patent claim only a drug substance that is a different polymorph of the active
ingredient described in the NDA?

Yes

No

If the answer to question 2.2 is “Yes,” do you certify that, as of the date of this
declaration, you have test data demonstrating that a drug product containing the
polymorph will perform the same as the drug product described in the NDA?
The type of test data required is described at 21 CFR 314.53(b).

Yes

No

2.4

Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.

2.5

Does the patent claim only a metabolite of the approved active ingredient?
(Complete the information in section 4 below if the patent claims an approved
method of using the approved drug product to administer the metabolite.)

2.6

Does the patent claim only an intermediate?

FORM FDA 3542 (8/16)

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Yes

No

Yes

No

2.7

If the patent referenced in 2.1 is a product-by-process patent,
is the product claimed in the patent novel?

Not Applicable

Yes

No

Yes

No

Yes

No

Yes

No

FDA will not list the patent in the Orange Book as claiming the drug substance if:
• the answers to 2.1 and 2.2 are “No,” or,
• the answer to 2.2 is “Yes” and the answer to 2.3 is “No,” or,
• the answer to 2.3 is “Yes” and there is no response to 2.4, or,
• the answer to 2.5 or 2.6 is “Yes.”
• the answer to 2.7 is “No.”

3. DRUG PRODUCT (COMPOSITION/FORMULATION)
3.1

Does the patent claim the approved drug product as defined in 21 CFR 314.3?

3.2

Does the patent claim only an intermediate?

3.3

If the patent referenced in 3.1 is a product-by-process patent,
is the product claimed in the patent novel?

Not Applicable

FDA will not list the patent in the Orange Book as claiming the drug product if:
• the answer to question 3.1 is “No,” or,
• the answer to question 3.2 is “Yes,” or,
• the answer to 3.3 is “No.”

4. METHOD OF USE
NDA holders must submit the information in section 4 for each approved method of using the approved drug product
claimed by the patent. An NDA holder may list together multiple patent claims for each approved method of use; however,
each approved method of use claimed by the patent must be separately identified within this section. Continuation pages
may be used to separately list method of use information within this section. For each approved method of use claimed by
the patent, provide the following information:
4.1

4.2

Does the patent claim one or more approved
methods of using the approved drug product?
(Select one)

Yes (only one approved method of use)
Yes (more than one approved method of use)

Patent Claim Number(s) (as listed in the patent) (Please separate
numbers with commas.)

Does (Do) the patent claim(s) referenced
in 4.2 claim an approved method of use
of the approved drug product?
Yes

4.2a If the answer to 4.2 is “Yes,” for each
approved method of use, separately
identify the specific section(s) and
subsection(s) of the approved labeling
for the drug product that describe
the approved method of use claimed
by the patent. If there is more than
one approved method of use, please
use the “Add Section 4.2” button for
additional entries as needed.

FORM FDA 3542 (8/16)

No

No

Use (In your answer below, please list each section on a separate line. Within each
line, separate each subsection with a comma.)

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4.2b If the answer to 4.2
is “Yes,” also provide
the information on the
approved method of use
claimed by the patent for
the Orange Book “Use
Code” description.

Use (Submit the description of the specific approved method of use claimed by the patent
that FDA should include as the “Use Code” in the Orange Book, using no more than 250
total characters including spaces.)

FDA will not list the patent in the Orange Book as claiming the method of use if:
• the answer to question 4.1 or 4.2 is “No,” or
• the answer to 4.2 is “Yes” and the information requested in 4.2a and 4.2b is not provided in full.
If more than one approved method of use, click to add a new set of Section 4.2 entries. May be repeated.

Add Section 4.2

5. NO RELEVANT PATENTS
For this NDA or supplement, there are no relevant patents that claim the approved drug
substance (active ingredient) or the approved drug product (formulation or composition)
or approved method(s) of use with respect to which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner of the patent engaged in the
manufacture, use, or sale of the drug product.

Yes

6. DECLARATION CERTIFICATION
6.1

The undersigned declares that this is an accurate and complete submission of patent information for the NDA or
supplement approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-sensitive patent
information or response to a request under 21 CFR 314.53(f)(1) is submitted pursuant to 21 CFR 314.53. I attest that I
am familiar with 21 CFR 314.53 and this submission complies with the requirements of the regulation. I verify under
penalty of perjury that the foregoing is true and correct.
Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.

6.2

Authorized Signature of NDA Holder or Patent Owner (Attorney, Agent, Representative or
other Authorized Official) (Provide Information below)

Date Signed

6.3

Countersignature of Authorized U.S. Agent

Date Signed

NOTE: Only an NDA holder may submit this declaration directly to the FDA. A patent owner who is not the NDA holder is
authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
Check applicable box and provide information below.
NDA Holder

NDA Holder’s Attorney, Agent (Representative) or Other
Authorized Official

Patent Owner

Patent Owner’s Attorney, Agent (Representative) or Other
Authorized Official

Name
Address
State/Province/Region
FAX Number (if available)

FORM FDA 3542 (8/16)

City
Country

ZIP or Postal Code

Telephone Number

E-Mail Address (if available)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 10 hours per response, including the time
to review instructions, search existing data sources, gather and maintain the data needed and complete and review
the collection of information. Send comments regarding this burden estimate or any other aspect of this information
collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“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 number.”

FORM FDA 3542 (8/16)

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