FAQs

1. How do I use the Purple Book database to find FDA-approved biosimilar or interchangeable biological products?
2. What does the reference product exclusivity expiration date indicate? What is a first licensure? Why don't some biological products have exclusivity expiration or first licensure dates listed?
3. What does the first interchangeable exclusivity date indicate?
4. What does the orphan exclusivity date indicate?
5. What Purple Book listing requirements were added by the Biological Product Patent Transparency section of the Consolidated Appropriations Act of 2021 enacted December 27, 2020?
6. How should reference product sponsors submit their initial list of patent information to FDA and what should the submission include?
7. When and how should reference product sponsors submit their updated patent information?
8. What Purple Book reporting requirements were added by section 3201 of the Consolidated Appropriations Act of 2023 enacted December 29, 2022?
9. How should BLA sponsors submit their one-time marketing status report under section 506I(c) of the FD&C Act to FDA and what should the submission include?
10. Are transition biological products included in the Purple Book?
11. How are "unbranded biologics" displayed in the Purple Book?
12. How often will the Purple Book be updated?
13. Where do I find information about the following CBER licensed products: Blood Bank and Source Plasma products, Medical Device BLAs and BLAs For Further Manufacturing Use?
14. How do I obtain information not found on the Purple Book?
15. What if I have questions regarding the Purple Book or believe it needs to be changed?

Frequently Asked Questions with Answers

Q1: How do I use the Purple Book database to find FDA-approved biosimilar or interchangeable biological products?
A1: Enter the name of a biological product in the Simple Search box or Advanced Search box.

The Simple Search is the default search bar on the 'Purple Book Homepage.' Enter a biological product's proprietary (brand) name or nonproprietary (proper) name into the search box. As you type, a list of potential results will begin to appear below the search box based on what you are typing. Once a product is chosen from the auto-populated results list, the ' Simple Search Results' page for the selected product will display all biological products that share a core name (i.e., biosimilar, interchangeable, reference, and related biological products). The Simple Search does not display the full set of data contained in the Purple Book for each biological product. To view the full set of product information for a particular product, see the Advanced Search.

The Advanced Search page can be accessed from the 'Purple Book Homepage' or from a product's 'Simple Search Results' page. Advanced Search provides comprehensive data for the searched biological products. The table will update in real time and display all products that match any of the terms entered in the search bar. A scroll bar at the bottom and right side of the table allows users to view a large amount of product information at one time.

A 351(k) biologics license application (BLA) may contain both biosimilar and interchangeable products. For such a BLA, there will be two product cards on the Simple Search results page - one under the 'Biosimilar(s)' heading and one under the 'Interchangeable(s)' heading. Both product cards will lead to the same 'Product Details' page, which will provide license type data for each product in that BLA.

See the User Guide for detailed instructions on how to use Simple Search and Advanced Search.

Q2: What does the reference product exclusivity expiration date indicate? What is a first licensure? Why don't some biological products have exclusivity expiration or first licensure dates listed?
A2: Generally, the reference product exclusivity expiration date indicates the date on which the 12-year period of exclusivity described in section 351(k)(7)(A) of the Public Health Service Act (PHS Act) expires, plus an additional six-month period of exclusivity pursuant to section 505(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), if applicable. The reference product exclusivity expiration date is the date on which approval of a 351(k) application referencing the reference product may be made effective, assuming it otherwise meets the requirements for licensure under section 351(k) of the PHS Act and licensure is not precluded by unexpired "orphan drug exclusivity" under section 527(a) of the FD&C Act. To determine whether there is unexpired orphan exclusivity for an indication(s) for which the reference product has been previously approved, please refer to the searchable database for Orphan Designated and/or Approved Products.

FDA has not made a determination of first licensure for each 351(a) biological product included in the Purple Book. The absence of a date of first licensure in the Purple Book does not mean that a biological product on the list is not, or was not, eligible for the periods of exclusivity described in section 351(k)(7) of the PHS Act.

For additional information on determining first licensure and reference product exclusivity, please see the draft guidance for industry, "Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (PDF - 99KB)."

Q3: What does the first interchangeable exclusivity date indicate?
A3: The date a first interchangeable product's period of exclusivity ends, which is the date that FDA may make a determination that a second or subsequent biological product is interchangeable with the reference product against which the first interchangeable biological product was evaluated for any condition of use. The presence of "Date TBD" in the Purple Book indicates that FDA has determined that the listed biological product is eligible for first interchangeable exclusivity, but FDA has not yet determined the applicable period of exclusivity under section 351(k)(6) of the PHS Act. The absence of a first interchangeable exclusivity expiration date in the Purple Book does not mean that a biological product on the list is not, or was not, eligible for the periods of exclusivity described in section 351(k)(6) of the PHS Act.

Q4: What does the orphan exclusivity date indicate?
A4: Indicates the date on which the seven-year period of orphan exclusivity expires, including any applicable pediatric extension. Where a product is protected by multiple periods of orphan exclusivity, the Orphan Exclusivity Expiry Date reflects the latest expiration date. For additional information on unexpired orphan exclusivity for an indication(s) for which the reference product has been previously approved, refer to the searchable database for Orphan Designated and/or Approved Products.

Q5: What Purple Book listing requirements were added by the Biological Product Patent Transparency section of the Consolidated Appropriations Act of 2021 enacted December 27, 2020?
A5: The Biological Product Patent Transparency (BPPT) section of the legislation requires that, by 180 days after enactment (June 25, 2021), FDA publish and make available to the public in a searchable, electronic format a list of biological products, by nonproprietary name, for which a biologics license under section 351(a) or 351(k) of the Public Health Service Act (PHS Act) is in effect; the date of licensure of the marketing application and the application number; the licensure status; and, if available, marketing status. The statute also requires that FDA revise the list every 30 days to include any additional products licensed under section 351(a) or 351(k) of the PHS Act. In addition, for each biological product on the list, the BPPT section requires that the Purple Book list each reference product exclusivity period and each first interchangeable exclusivity period for which FDA has determined such biological product to be eligible and for which such period has not concluded.

The BPPT section further requires publication in the Purple Book of patent lists provided by reference product sponsors (i.e., biologics license application (BLA) holders) to FDA for certain licensed biological products. Specifically, a reference product sponsor is required to provide to FDA the list of patents and corresponding expiry dates (referred to here as the "initial list"), not later than 30 days after the reference product sponsor has provided the initial list to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. The reference product sponsor is also required to provide to FDA any subsequent or supplemental lists, and their corresponding expiry dates, within 30 days of the provision of such lists to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. FDA began publishing patent lists in the Purple Book 180 days after the date of enactment (June 25, 2021). FDA intends to revise the published list on a monthly basis to include any additional initial lists and any updates from subsequent or supplemental lists. FDA's role in publishing patent information is ministerial, and FDA does not consider the applicability of patents to a biosimilar product (e.g., validity, enforceability, or potential infringement) in publishing the information described in section 351(k)(9) of the PHS Act, nor in FDA's review of a 351(k) BLA or supplement to a 351(k) BLA. Upon receiving a submission as described in Q6-7, FDA intends to verify only that the Reference Product BLA number, Applicant Name, Proprietary Name, and Proper Name match those in the Purple Book. If a reference product sponsor submits an initial or updated patent list in which this information does not match the information in the Purple Book, FDA intends to request that the reference product sponsor resubmit the patent list with updated information.

Q6: How should reference product sponsors submit their initial list of patent information to FDA and what should the submission include?
A6: At this time, the Agency requests that applicants submit their initial list as a Microsoft Excel spreadsheet to their respective BLA file via the Electronic Submissions Gateway, along with a Cover Letter. The spreadsheet should include the following fields: Reference Product BLA number, Applicant Name, Proprietary Name, Proper Name, Patent Number, Patent Expiration Date.

The Cover Letter subject should read, "PURPLE BOOK PATENT INFORMATION."

Also, send an email copy of the Cover Letter and spreadsheet to PurpleBook@fda.hhs.gov.

Q7: When and how should reference product sponsors submit their updated patent information?
A7: If the reference product sponsor has provided a list of patents to a 351(k) applicant as described in section 351(l)(3)(A) or (l)(7)of the PHS Act and to FDA as described in section 351(k)(9)(A)(iii) of the PHS Act, the reference product sponsor is also required to update this information with any additional patents from any subsequent or supplemental lists, and their corresponding expiry dates, within 30 days of the provision of such lists to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act.

Applicants should submit any updates in a Microsoft Excel file that follows the same format as the initial submission format described in Q6 to their respective BLA file via the Electronic Submissions Gateway, along with a Cover Letter. Only include additional patents and their corresponding expiration dates in an update submission. Applicants do not need to duplicate information already submitted in an initial list or previous update submission.

The Cover Letter should read, "PURPLE BOOK PATENT INFORMATION - UPDATE."

Corrections to submitted patent information (including correcting typographical errors) should be submitted under a Cover Letter reading, "PURPLE BOOK PATENT INFORMATION-CORRECTION."

For updates and corrections, also send an email copy of the Cover Letter and spreadsheet to PurpleBook@fda.hhs.gov.

Q8: What Purple Book reporting requirements were added by section 3201 of the Consolidated Appropriations Act of 2023 enacted December 29, 2022?
A8: Section 3201 of the Consolidated Appropriations Act of 2023 amended section 506I of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include applications approved under subsection (a) or (k) of section 351 of the Public Health Service Act (PHS Act). As amended, section 506I imposes certain reporting requirements on biologics license application (BLA) holders regarding the marketing status of approved products, including a one-time marketing status report.

Section 506I(c) of the FD&C Act requires that all BLA sponsors review information published in the Purple Book and submit a one-time written report to FDA indicating that:

• 1. the BLA sponsor's product(s) in the Purple Book that have a status of "Rx" are available for sale; or


• 2. one or more of the BLA sponsor's products in the Purple Book that have a status of "Rx" have been withdrawn from sale or have never been available for sale.

Section 506I(c) of the FD&C Act requires that this one-time marketing status report be submitted to the FDA within 180 days of enactment (i.e., by Tuesday, June 27, 2023).

Q9: How should BLA sponsors submit their one-time marketing status report under section 506I(c) of the FD&C Act to FDA and what should the submission include?
A9: The BLA holder can provide the one-time report to FDA by submitting a Cover Letter to each applicable BLA file (i.e., each approved BLA with products listed as having a status of "Rx" in the Purple Book that is covered by such one-time report) via the Electronic Submissions Gateway. If a BLA sponsor has multiple BLAs to address in the one-time report, the same report can be submitted to each applicable BLA file as long as the report addresses each biological product licensed under all of the sponsor's applicable BLAs. In other words, the same report can be submitted to each applicable BLA file as part of a single grouped submission or separate reports addressing individual products can be submitted to each applicable BLA file. The sponsor should prominently identify the submission as "MARKETING STATUS REPORT / ONE-TIME UPDATE." The sponsor should also send an email with a copy of the Cover Letter to PurpleBook@fda.hhs.gov.

The Cover Letter should indicate whether:

• all of the BLA sponsor's products in the Purple Book with a status of "Rx" are available for sale; or
• one or more of the BLA sponsor's products in the Purple Book with a status of "Rx" have been discontinued from sale or have never been available for sale.

If all of the BLA sponsor's products in the Purple Book with a status of "Rx" are available for sale, the one-time report should include a statement confirming that the sponsor has reviewed the information published in the Purple Book and that all of the biological products listed with a status of "Rx" in the Purple Book are available for sale.

If one or more of the BLA sponsor's products listed with a status of "Rx" in the Purple Book have been discontinued from sale or have never been available for sale, the report should include the following:

• For biological products that have been discontinued from sale:
  • National Drug Code;
  • Proper name;
  • Proprietary name, if applicable;
  • BLA number;
  • Strength, as listed in the Purple Book;
  • Date on which the product is expected to no longer be available, or was no longer available for sale; and
  • Reason(s) the product will be, or is, discontinued from sale.
  
  
• For biological products that have never been available for sale:
  • Proper name;
  • Proprietary name, if applicable;
  • BLA number;
  • Strength, as listed in the Purple Book;
  • Date on which the product will be available for sale, if known and applicable; and
  • Reason(s) for not marketing the product after approval.

Q10: Are transition biological products included in the Purple Book?
A10: Yes. All biological-products approved in New Drug Applications (NDAs) that were deemed to be Biologics License Applications (BLAs) on March 23, 2020 (transition biological products) are included in the Purple Book database. The Purple Book database identifies the date of initial approval under section 505 of the FD&C Act.

For more information about transition biological products, visit the "Deemed to be a License" Provision of the BPCI Act webpage.

Q11: How are "unbranded biologics" displayed in the Purple Book?
A11: The term "unbranded biologic" or "unbranded biological product" generally describes an approved brand name biological product that is marketed under its approved BLA without its brand name (proprietary name) on its label. Because an unbranded biologic is marketed under the brand name biological product's BLA and is not different in strength, dosage form, route of administration, or presentation, it is not separately identified in the Purple Book. An "unbranded biologic" is not an "interchangeable biosimilar." However, an unbranded biologic is considered by FDA to be equivalent to its brand name biological product because it is the same product as the brand name biological product under the same BLA.

Q12: How often will the Purple Book be updated?
A12: An FDA-approved biological product or updates to an approved product's information will generally be added to the Purple Book within 10 business days of approval.

Q13: Where do I find information about the following CBER licensed products: Blood Bank and Source Plasma products, Medical Device BLAs and BLAs For Further Manufacturing Use?
A13: All CBER licensed products and their supporting information can be found alphabetically by product name at Licensed Biological Products with Supporting Documents and by licensed year at Biological Approvals by Year. For further information please contact purplebook@fda.hhs.gov.

Q14: How do I obtain information not found on the Purple Book?
A14: Requests for more specific information may be obtained via the Freedom of Information Act. Requests should be submitted in writing or directed to the FDA's Division of Freedom of Information at:

Food and Drug Administration
Division of Freedom of Information
Office of the Executive Secretariat, OC
12420 Parklawn Drive
ELEM-1029
Rockville, MD 20857
Telephone: (301) 796-3900

The CDER Freedom of Information Office Electronic Reading Room and the CBER Freedom of Information Office Electronic Reading Room also have additional information available.

Q15: What if I have questions regarding the Purple Book or believe it needs to be changed?
A15: The Purple Book database downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Purple Book data files. If you would like to make a suggestion or if you wish to report an error or discrepancy in the data, please send a brief description of the problem to purplebook@fda.hhs.gov.

For questions on CDER biological products in the Purple Book, please contact the Division of Drug Information (CDER):

By phone: (855) 543-3784 or (301) 796-3400
By email: druginfo@fda.hhs.gov

For questions on CBER biological products in the Purple Book, please contact the CBER Consumer Affairs Branch CBER:

By phone: (800) 835-4709 or (240) 402-8010
By email: ocod@fda.hhs.gov