FDA 3542 Patent Information After Approval

INSTRUCTIONS FOR FILLING OUT FORM FDA 3542 – PATENT INFORMATION SUBMITTED

UPON AND AFTER APPROVAL OF AN NDA OR SUPPLEMENT

(The field numbers below correspond to the numbered and lettered boxes on the Form FDA 3542.)
NOTE: Please submit a new Form FDA 3542 for each patent that claims a drug substance (active
ingredient), drug product (formulation or composition), and/or method of using the approved drug
product. Complete a separate form for each patent. Complete the pages of the form sequentially and
use the “add section” option as applicable.

GENERAL INSTRUCTIONS
• The New Drug Application (NDA) holder must submit patent information to its NDA using the appropriate
form (see 21 CFR 314.53(d)). Use this Form FDA 3542 only if the NDA holder is submitting information
on a patent that claims an approved drug or an approved method of using the drug. If the NDA holder is
submitting patent information with an original NDA, an amendment, or a supplement prior to approval, you
must use Form FDA 3542a.
• Form FDA 3542 must be submitted to the NDA within 30 days after the date of approval of the NDA or
supplement or within 30 days of issuance of a patent as required by 21 CFR 314.53(c)(2)(ii).
Except as provided in 21 CFR 314.53(f)(1), an amendment to the description of the approved method(s) of
use claimed by the patent is required to be submitted on Form FDA 3542 within 30 days of patent issuance,
within 30 days of approval of a corresponding change to product labeling, or within 30 days of a decision
by the U.S. Patent and Trademark Office or by a Federal district court, the Court of Appeals for the Federal
Circuit, or the U.S. Supreme Court that is specific to the patent and alters the construction of a method-ofuse claim (s) of the patent, and the amendment contains a copy of the decision (see 21 CFR 314.50(i)(4)(i)
(C) and 314.94(a)(12)(vi)(A)(3)).
• Provide all patent information required by 21 CFR 314.53(c)(2). FDA will not list patent information if Form
FDA 3542 does not contain the required information or if the submission indicates that the patent is not
eligible for listing. Patent information on a listed drug that has been discontinued from marketing is eligible
for listing, provided that the general requirements for patent listing are met.
• If the NDA holder timely submits the required patent information on Form FDA 3542, but FDA notifies the
NDA holder that its Form FDA 3542 is incomplete or shows that the patent is not eligible for listing, the NDA
holder must submit an acceptable Form FDA 3542 within 15 days of FDA’s notification to be considered
timely filed as of the date of the original submission of patent information (see 21 CFR 314.53(c)(2)(ii)).
• P
lease do not submit this form directly to the Orange Book Staff in the Office of Generic Drugs. The form
must be submitted to the NDA.
• P
lease do not submit a copy of the patent to FDA.
• If you are a patent owner and are completing the form for the NDA holder to submit to its NDA (see 21 CFR
314.53(c)(2)(ii)(S) and (c)(4)), please note that you may need to obtain information from the NDA holder
in order to complete the form. If required information is not provided on the form, you will not be able to
electronically sign the form and FDA will not consider the form to be complete.

INFORMATION ON THE APPROVED DRUG PRODUCT(S) FOR WHICH PATENT INFORMATION IS
BEING SUBMITTED
NDA Number: Provide the six-digit application number and, if applicable, the supplement number (e.g.,
S-001). For application numbers less than six digits, the application number should be preceded by one or
more zeros (e.g., for NDA 12345 enter 012345). Provide only one NDA number. If you are submitting patent
information on drug products approved in different NDAs, you must submit a separate form for each NDA.

FORM FDA 3542 SUPPLEMENT (11/16) – FORM INSTRUCTIONS

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Name of NDA Holder: Provide the name of the person or legal entity that owns the approved NDA for the
approved drug product(s) for which patent information is being submitted.
Trade Name: Provide the proprietary name of the approved drug product(s), if any. If there is no trade name
for the approved drug product(s), leave this field blank.
Active Ingredient(s): List the active ingredient(s) in the approved drug product(s) for which the patent
information is being submitted.
Dosage Form(s): List the dosage form(s) of the approved drug product(s) claimed by the patent for which the
patent information is being submitted.
Strength(s): List the strength(s) of the approved drug product(s) claimed by the patent for which the patent
information is being submitted.
Route(s) of Administration: List the route(s) of administration of the approved drug product(s) claimed by the
patent for which the patent information is being submitted.
Type of Use: Indicate whether the approved drug product(s) for which the patent information is being
submitted is/are approved for prescription or over-the-counter use.
Approval Date of NDA or Supplement To Which Patent Information Relates: Indicate whether the patent
information relates to the drug product(s) approved in the original NDA or the drug product(s) as changed by
an approved supplement to the NDA, and enter the corresponding “date of approval” as defined in 21 CFR
314.3(b). You may manually enter the date in MM/DD/YYYY format or you may use the calendar.

SECTION 1 – GENERAL
** NOTE: If there are no relevant patents for this NDA or supplement, leave Sections 1, 2, 3, and 4 blank
and proceed to Section 5 “NO RELEVANT PATENTS.” **
Field 1.a: Provide the United States patent number (using no more than 10 characters, including commas).
Provide only one patent number. If you are submitting information on more than one patent for the NDA or
supplement, you must submit a separate form for each patent.
Field 1.b: Provide the date on which the patent was issued by the U.S. Patent and Trademark Office (PTO).
You may manually enter the date in MM/DD/YYYY format or you may use the calendar.
Field 1.c: Provide the patent expiration date, including any patent term extension that already has been
granted under 35 U.S.C. 156(e). You may manually enter the date in MM/DD/YYYY format or you may use
the calendar. Do not include any applicable pediatric exclusivity. FDA will publish any applicable pediatric
exclusivity in FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book).
Field 1.d: Provide the name, street address, city, state/province/region, country, zip or postal code, telephone
number and, if available, the fax number and e-mail address of each owner of the patent. Complete each
required section, including country, and provide the area code or country code, as applicable, for the telephone
or fax number. If there is more than one owner of the patent, click the “Add section 1.d” button for an additional
set of 1.d entries.
Field 1.e: If applicable, provide the name, street address, city, state, zip code, telephone number and, if
applicable, fax number and e-mail address of the agent or representative who resides or maintains a place of
business in the United States. Complete each required section, including country, and provide the area code or
country code, as applicable, for the telephone or fax number. If there is more than one agent or representative
(i.e., because the NDA holder and one or more owners of the patent do not reside or maintain a place of
business in the United States), click the “Add section 1.e” button for an additional set of 1.e entries and state
in the name field whether the person is an agent or representative for the NDA holder or a patent owner. If the
NDA holder and each patent owner reside or maintain a place of business in the United States, leave this field
blank.
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Field 1.f: Provide the name, street address, city, state/province/region, country, zip or postal code, telephone
number and, if available, the fax number and e-mail address of the NDA holder. Complete each required
section, including country, and provide the area code or country code, as applicable, for the telephone or fax
number.
Field 1.g: Indicate whether the patent has been submitted previously for listing in the Orange Book for this
drug product.
Field 1.h: If the answer to question 1.g is “yes,” identify all change(s) from the previously submitted Form FDA
3542 and specify whether each change is related to the patent (e.g., a patent term extension or patent-specific
decision by the PTO or a Federal court) or related to an FDA action (e.g., FDA approval of a supplement that
changes the approved conditions of use of the drug) or an FDA procedure (e.g., an NDA holder’s response to
a patent listing dispute).

SECTION 2 – DRUG SUBSTANCE (ACTIVE INGREDIENT)
** If the patent is eligible for listing as claiming the drug substance AND section 2 is completed, you do not
need to complete section 3 even if the patent also is eligible for listing as claiming the drug product. **
If the patent claims a drug substance that is the subject of the approved NDA or supplement AND you are
submitting the patent for listing on this basis, complete all required fields within this section. FDA will consider
incomplete a patent declaration that does not include a response to all required questions contained within
each applicable section.
Field 2.1: If you answer “yes” to question 2.1, you can skip to question 2.5.

Field 2.2: Answer this question only if you answer “no” to question 2.1.

Field 2.3: Answer this question only if you answer “yes” to question 2.2.

Field 2.4: Answer this question only if you answer “yes” to question 2.3.

Field 2.5: A patent that claims only a metabolite of the approved active ingredient will not be listed. If the

patent claims an approved method of using the approved drug product to administer the metabolite, the patent

may be listed as a method-of-use patent depending on the responses in section 4.

Field 2.6: A patent that claims only an intermediate of the drug substance that is the active ingredient in the

approved drug product will not be listed.

Field 2.7: Answer this question, as appropriate.

SECTION 3 – DRUG PRODUCT (COMPOSITION/FORMULATION)
** If the patent is eligible for listing as claiming the drug product AND section 3 is completed, you do not need
to complete section 2 even if the patent also is eligible for listing as claiming the drug substance. **
If the patent claims the drug product that is the subject of the approved NDA or supplement AND you are
submitting the patent for listing on this basis, complete all required fields within this section. FDA will consider
incomplete a patent declaration that does not include a response to all required questions contained within
each applicable section.
Field 3.2: A patent that claims only an intermediate of the approved drug product will not be listed.
Field 3.3: Answer this question, as appropriate.

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SECTION 4 – METHOD OF USE
Complete all required fields in this section if the patent claims one or more approved method(s) of using the
approved drug product. If you answer yes to question 4.1, you also are required to state whether the patent
also claims the drug substance or drug product. Accordingly, make sure you have completed section 2 or
section 3, if appropriate.
Field 4.1: Indicate whether the patent claims one or more approved method(s) of using the approved drug
product. If the patent claims more than one approved method of use, separately identify and complete Fields
4.2, 4.2a, and 4.2b for each approved method of use claimed by the patent. Click the “Add section 4.2” button
to add a new set of section 4.2 entries for each approved method of use claimed by the patent.
Field 4.2: For each approved method of use claimed by the patent, identify by number the claim(s) listed in the
patent that claim that specific approved method of use. You may list together multiple patent claim numbers
(as listed in the patent) for each approved method of use (e.g., list “claims 1, 2, 3” for the first approved
method of use); however, each approved method of use must be separately identified with a new set of
section 4.2 entries. (After completing section 4.2 for the first approved method of use, click the “Add section
4.2” button to add a new set of section 4.2 entries if needed. For example, list “claims 4, 5, 6” for the second
approved method of use claimed by the patent). Use a comma to separate each patent claim number provided
for the approved method of use. Confirm whether the patent claim(s) listed in section 4.2 claim an approved
method of using the approved drug product by checking the appropriate box. If there is more than one patent
claim number listed in section 4.2, each of the patent claim(s) listed in section 4.2 must claim an approved
method of using the approved drug product to check the “yes” box.
Field 4.2a: For each approved method of use, list the specific section(s) and subsection(s) of the approved
product labeling that contain information describing the specific approved method of use claimed by the
patent. List each section of labeling on a separate line using the format described below. Within each line,
separate each subsection with a comma.
• Prescription drug products with labeling in the “physician labeling rule” (PLR) format: the section(s) and
subsection(s) of the approved labeling should be identified by the section and subsection number (see
21 CFR 201.56(d) and 201.57). For example, “section 1, subsection 1” refers to the first indication listed
in approved product labeling (see 21 CFR 201.57(c)(2)). If there is no applicable subsection, insert
“subsection 0.”
• Prescription drug products with labeling not in PLR format: the section(s) and subsection(s) of the
approved labeling should be identified by the section and subsection titles (see 21 CFR 201.56(b) and
(e) and 201.80). For example, “section ‘Indications and Usage,’ subsection ‘Hypertension.’” If there is no
applicable subsection, insert “subsection ‘N/A.’”
• Nonprescription drug products: the section(s) and subsection(s) of the approved labeling should be
identified by the section and subsection titles (see 21 CFR 201.66). For example, “section ‘Uses,’
subsection ‘temporarily relieves minor aches and pains due to headache.’” If there is no applicable
subsection, insert “subsection ‘N/A.’”
Field 4.2b: For each approved method of use, provide 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. Each use code must
describe only an approved method of use claimed by the patent for which a claim of patent infringement could
reasonably be asserted if a person not licensed by the patent owner engaged in the manufacture, use, or
sale of the drug product. In other words, the scope of the use code must not extend beyond the scope of the
patent claim(s) and, within the boundary established by the patent claim(s), the use code must only describe
a patented method of use that has been approved by FDA as reflected in approved product labeling. The use
code must contain adequate information to assist 505(b)(2) application and abbreviated new drug application
(ANDA) applicants in determining whether a listed method-of-use patent claims a use for which the 505(b)(2)
application or ANDA applicant is not seeking approval (see 21 CFR 314.53(c)(2)(ii)(P)(3)). Use a maximum of
250 characters for each use code, and follow the general principles described below.

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• Patented method of use is broader than an indication or other approved condition of use in the labeling:
The use code must only describe a patented method of use that is described in FDA-approved product
labeling. If the method of use claimed by the patent uses different terminology than the approved
labeling and/or is broader than an indication or other approved condition of use, then the use code
would need to be phrased more narrowly than the patent claim to only describe the specific patented
method of use that is described in FDA-approved product labeling.
• Patented method of use is co-extensive with an indication or other approved condition of use in the
labeling: The use code must describe only the specific approved method of use claimed by the patent.
• Patented method of use is narrower than an indication or other approved condition of use in the
labeling: If the method of use claimed by the patent does not cover an indication or other approved
condition of use in its entirety, then the NDA holder must describe only the specific approved method
of use claimed by the patent for which a claim of patent infringement could reasonably be asserted if a
person not licensed by the patent owner engaged in the manufacture, use, or sale of the drug product—
not the broader indication or other approved condition of use that may include, but is broader than, the
use claimed by the patent.

SECTION 5 – NO RELEVANT PATENTS
Field 5: Complete this section only if there are no relevant patents for this NDA or supplement, AND section
1.a is blank.

SECTION 6 – DECLARATION CERTIFICATION
Fields 6.1 through 6.3: Read the required declaration, then sign and date the form in Field 6.2. If the person
signing the form in field 6.2 does not reside or have a place of business in the United States, the form must
also be countersigned in Field 6.3 by an attorney, agent, or other authorized official who resides or maintains
a place of business within the United States. Check the applicable box that describes the authorized signature
provided in Field 6.2, and provide the name, street address, city, state/province/region, country, zip or postal
code, telephone number and, if available, the fax number and e-mail address of the person signing the form
in Field 6.2. Complete each required section, including country, and provide the area code or country code, as
applicable, for the telephone or fax number.

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