Form FDA 3542a Patent Information Submitted With the Filing of an NDA,

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 WITH THE
FILING OF AN NDA, AMENDMENT, OR SUPPLEMENT
For Each Patent That Claims a Drug Substance
(Active Ingredient), Drug Product (Formulation and
Composition) and/or Method of Use

NDA Number
Name of NDA Applicant

Refer to instruction sheet (Form FDA 3542a 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 (or proposed Trade Name)

Active Ingredient(s)

Dosage Form(s)

Strength(s)

Route(s) of Administration

Type of Use
Prescription

Over-the-Counter

This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA, amendment, or
supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4). Within thirty (30) days after the date of
approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent declaration must be submitted on
Form FDA 3542 pursuant to 21 CFR 314.53(c)(2)(ii) with all of the required information based on the approved NDA or supplement. FDA
will not list or publish patent information in the Orange Book if it is not submitted in the declaration form submitted upon or after approval.
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 pending NDA, amendment, or supplement referenced above, you must submit the
information described below. If you are not submitting any patents for this pending NDA, amendment, or supplement,
complete the section above and sections 5 and 6.

1. GENERAL
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.

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 applicant 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.

FORM FDA 3542a (8/16)

Add Section 1.d.

Page 1 of 4

Add Section 1.e.

PSC Publishing Services (301) 443-6740

EF

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

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 the NDA or supplement?

Yes

No

h. If the answer to question 1.g. is “Yes,” identify all change(s) from the previously submitted Form 3542a 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, and/or method of use that is the subject of the pending NDA, amendment, or supplement.
• 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.

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 pending NDA, amendment, 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 pending NDA, amendment, or supplement?

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 active ingredient pending in the NDA
or supplement? (Complete the information in section 4 below if the patent claims a
pending method of using the pending drug product to administer the metabolite.)

2.6

Does the patent claim only an intermediate?

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

Yes

No

Yes

No

3. DRUG PRODUCT (COMPOSITION/FORMULATION)
3.1

Does the patent claim the drug product, as defined in 21 CFR 314.3, in the pending
NDA, amendment, or supplement?

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?

FORM FDA 3542a (8/16)

Page 2 of 4

Not Applicable

4. METHOD OF USE
NDA applicants must submit the information in section 4 for each method of using the proposed drug product for which
approval is being sought and that is claimed by the patent. An NDA applicant may list together multiple patent claims for
each pending method of use; however, each pending 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 pending method of use claimed by the patent, provide the following information:
4.1

4.2

Does the patent claim one or more methods of use
for which approval is being sought in the pending
NDA, amendment, or supplement?

Yes (only one pending method of use)

No

Yes (more than one pending 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 a pending method of use
for which approval is being sought
in the pending NDA, amendment, or
supplement?
Yes

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

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

If more than one pending method of use, click to add a new set of Section 4.2 entries. May be repeated.

5. NO RELEVANT PATENTS
For this pending NDA, amendment, or supplement, there are no relevant patents that
claim the drug substance (active ingredient), drug product (formulation or composition) or
method(s) of use, for which the applicant is seeking approval and 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.

FORM FDA 3542a (8/16)

No

Page 3 of 4

Yes

Add Section 4.2

6. DECLARATION CERTIFICATION
6.1

The undersigned declares that this is an accurate and complete submission of patent information for the NDA,
amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This timesensitive patent information 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 Applicant 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 applicant may submit this declaration directly to the FDA. A patent owner who is not the NDA
applicant 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 Applicant

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

Patent Owner

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

Name
Address

City

State/Province/Region
FAX Number (if available)

Country

ZIP or Postal Code

Telephone Number

E-Mail Address (if available)

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 15 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
[email protected]
“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 3542a (8/16)

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