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The FDA Purple Book is FDA’s searchable online database of biological products licensed under the Public Health Service (PHS) Act, including biosimilar and interchangeable products and the reference products they are measured against. Use the Simple Search to see one product family, and the Advanced Search to sort, filter and export every field.
This page describes a regulatory database and is not medical advice. The name “Purple Book” is also used for unrelated publications; this page covers only the FDA database.
What the FDA Purple Book is
The Purple Book began as two lists of licensed biological products, one for the Center for Drug Evaluation and Research (CDER) and one for the Center for Biologics Evaluation and Research (CBER). In February 2020 FDA released a searchable online database that replaced both lists; the older lists are no longer updated.
Purple Book FDA: the official names
The database is titled Purple Book Database of Licensed Biological Products, and the FDA web page that introduces it is titled Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. Both refer to the same resource.
Who runs it and what it covers
FDA runs the database. It contains all FDA-licensed biological products regulated by CDER, including licensed biosimilar and interchangeable products and their reference products, plus the FDA-licensed allergenic, cellular and gene therapy, hematologic and vaccine products regulated by CBER. Biological products approved in New Drug Applications that were deemed to be Biologics License Applications (BLAs) on March 23, 2020 (“transition biological products”) are included. For how CBER-regulated cell and gene therapy products are approved, see FDA Approval for Gene Therapy.
FDA’s About page lists what a user can find:
- the date a product was licensed under section 351(a) or 351(k) of the PHS Act;
- whether a 351(k) product has been determined to be biosimilar to, or interchangeable with, a reference product;
- the expiry date of reference product exclusivity (section 351(k)(7)) or first interchangeable exclusivity (section 351(k)(6)), where FDA has determined a product is eligible;
- patent information for certain licensed biological products, required by the Biological Product Patent Transparency section of the Consolidated Appropriations Act of 2021.
New products and updates are generally added within 10 business days of approval. For background on the product class itself, see the guide What Is a Biologic Drug?, and for the 351(k) pathway see FDA Biosimilars (351(k) Pathway).
Key terms and dates the Purple Book uses
Most confusion comes from the labels and dates, not the search box. This table restates FDA’s own definitions.
| Term in the Purple Book | What FDA says it means |
|---|---|
| Reference product | The single biological product licensed under section 351(a) against which a proposed product is evaluated in a section 351(k) application (section 351(i)(4)). |
| Biosimilar | Highly similar to the reference product notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences in safety, purity and potency (section 351(i)(2)). |
| Interchangeable | Shown to be biosimilar and expected to produce the same clinical result as the reference product in any given patient; for a product given more than once, the risk of alternating or switching must not be greater than the risk of using the reference product without switching (section 351(k)(4)). |
| Reference Product Exclusivity Expiration Date | The date 12 years after first licensure of the reference product, plus any pediatric exclusivity (six months, where applicable). It is the date a 351(k) approval may be made effective, if not blocked by orphan or other exclusivity. |
| First Interchangeable Exclusivity Expiration Date | The date FDA may determine that a second or later product is interchangeable with the same reference product. “Date TBD” means FDA found the product eligible but has not yet set the period. |
| Orphan Exclusivity Expiration Date | The end of the seven-year orphan exclusivity period, including any pediatric extension; where several periods apply, the latest date is shown. See Orphan Drug Designation. |
Worked example: the 4-year and 12-year windows
Section 351(k)(7) bars a 351(k) application from being submitted for review until 4 years after the reference product was first licensed, and bars approval from being made effective until 12 years after. As a hypothetical illustration only: a reference product first licensed on 1 March 2010 could not have a 351(k) application submitted before 1 March 2014, and approval could not take effect before 1 March 2022 (six months later if pediatric exclusivity applies). The dates in the database for a real product are the authority.
How to search or use it
These steps follow FDA’s User Guide on the database site.
- Open the Purple Book Homepage. The Simple Search bar is the default search.
- Type a brand (proprietary) name or a proper (nonproprietary) name. A list of possible matches appears as you type.
- Click a product in the auto-populated list to open the “Simple Search Results” page. It shows every product that shares a core name: biosimilar, interchangeable, reference and related products.
- Read the product cards. Matching card colours mark a biosimilar or interchangeable product and the reference product it matches. A single 351(k) BLA can appear twice, under “Biosimilar(s)” and “Interchangeable(s)”, both leading to the same “Product Details” page.
- Click the proprietary name to open “Product Details”, which shows the license type (351(k) Biosimilar or 351(k) Interchangeable) and, where provided, a “Patent List Provided” link.
- For the full data set, click “Advanced Search” under the search box. Enter several terms separated by spaces (for example names and strengths); the table updates in real time and shows products matching any term.
- Use “Show/Hide Columns” and “Additional Search Filters” to shape the table, sort by clicking a column title, and choose how many rows to show.
- Use “Export data” to download the table as CSV, MS-Excel or PDF. “Reset” clears all entries.
The “Patent List” page has its own row and card views and export. The “Product Label” link is inactive where no label is available, for example revoked products.
Monthly data downloads
“Download Purple Book Data” offers monthly reports in CSV or XLSX, with archive folders for earlier years. The top section of each report lists changes in three categories: updated products (U), newly approved products (N) and products added in the current release (R). The bottom section lists every product in the database for that month.
Strengths and limits
Strengths: CDER and CBER licensed biological products in one database, related products grouped by core name, and exportable results and monthly files.
Limits FDA documents
- The Simple Search does not show the full data set; the Advanced Search does.
- A missing date of first licensure, or a missing exclusivity date, does not mean a product was not eligible for exclusivity.
- FDA’s role in publishing patent information is ministerial. It does not assess validity, enforceability or potential infringement.
- An unbranded biologic is marketed under the brand product’s BLA and is not separately identified; it is not an “interchangeable biosimilar”.
- For CBER Blood Bank and Source Plasma products, medical device BLAs and BLAs for further manufacturing use, FDA’s FAQ points to CBER’s own product lists (see the table below).
Alternatives and companion FDA resources
| Resource | Use it for | Basis |
|---|---|---|
| FDA Orange Book | Drug products approved under the Federal Food, Drug, and Cosmetic Act, with related patent and exclusivity information. Generic-drug context: FDA ANDA Application. | FDA Orange Book page |
| Drugs@FDA and DailyMed | Current labeling. The Purple Book’s “Product Label” link goes to Drugs@FDA (CDER products) or DailyMed (CBER products). | Purple Book User Guide |
| Licensed Biological Products with Supporting Documents; Biological Approvals by Year (CBER) | All CBER licensed products, listed alphabetically by product name or by year of licensure. FDA’s FAQ points here for CBER Blood Bank and Source Plasma products, medical device BLAs and BLAs for further manufacturing use. | Purple Book FAQ 13 |
| FDA orphan product database | Checking unexpired orphan exclusivity for indications of the reference product. | Purple Book FAQ 2 and 4 |
| Freedom of Information Act request | Information not published in the Purple Book. See FDA FOIA Request. | Purple Book FAQ 14 |
FAQ
Questions drawn from FDA’s own Purple Book FAQ list, plus the common comparison with the Orange Book.
How do I find FDA-approved biosimilar or interchangeable products?
Enter the reference or biosimilar product name in the Simple Search box and open the results page; it lists all products sharing the core name. Use the Advanced Search to see license type and dates in a table.
How often is the Purple Book updated?
FDA says an approved product, or an update to its information, will generally be added within 10 business days of approval; the downloadable data files are updated monthly.
What is the difference between the Purple Book and the Orange Book?
The Purple Book covers licensed biological products under the PHS Act. The Orange Book covers drug products approved under the Federal Food, Drug, and Cosmetic Act, with related patent and exclusivity information.
How do I get information the Purple Book does not publish?
FDA directs such requests to the Freedom of Information Act process.
Sources
- FDA, Purple Book Database of Licensed Biological Products: purplebooksearch.fda.gov, including its About Purple Book, User Guide, FAQs and Download Purple Book Data pages. Checked 2026-11-07.
- FDA, Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations: fda.gov. Checked 2026-11-07.
- FDA, Background Information: List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book): fda.gov. Checked 2026-11-07.
- FDA, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book): fda.gov. Checked 2026-11-07.
