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U.S. Food and Drug Administration

Purple Book
Database of Licensed Biological Products

User Guide

Simple Search Steps

The Simple Search is the default search bar on the ‘Purple Book Homepage.’ 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 information for a particular product, please use the Advanced Search option.

  1. 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 in the auto-populated results list below the search box based on what you are typing.
  2. Click on a product from the auto-populated results list to view the ‘Simple Search Results’ page for your selected product.
    • 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).
    • Matching product card colors on the results page indicate a biological product is biosimilar to or interchangeable with a reference product with the same product card color.
    • 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.
  3. On the ‘Simple Search Results’ page, each product card includes both the proprietary (brand) name and proper (nonproprietary) name. On each product card, you will find product presentation icons. Hover over the icons to display additional information about the product’s usage. To view a list and definitions of product presentation icons, click the link at the bottom of the ‘Simple Search Results’ page.
  4. To view the current label, click on the ‘Product Label’ icon/link on a product card. This will bring up a new window with the product’s landing page within Drugs@FDA for CDER regulated products or the National Library of Medicine’s DailyMed website for CBER regulated products. For products where a label is not available (e.g., revoked products), the 'Product Label’ icon/link will not be active.
    • Within Drugs@FDA, click the ‘Labels for BLA’ header and click the most recently dated ‘Label’ link to view the current prescribing information or labeling (e.g., Medication Guide, Instructions for Use, etc.).
    • Within DailyMed, the link will go directly to the label or the search results page if there are multiple labels for a product.
  5. Click the ‘Proprietary Name’ link on a product card to access the ‘Product Details’ page, which will display additional information for a specific product.
    • If a BLA contains products biosimilar to their reference product as well as products interchangeable with their reference product, the ‘License Type’ column on the ‘Product Details’ page will list “351(k) Biosimilar” or “351(k) Interchangeable” for each product in that BLA, as appropriate.
  6. To view patent list information for certain licensed biological products where patent list information has been provided, click the ‘Yes’ link under the heading ‘Patent List Provided’ on the ‘Product Details’ page.
  7. To see additional product information for all results, click ‘Navigate to Advanced Search’ on the ‘Simple Search Results’ page.
  8. To conduct additional searches or make changes to your existing search, click ‘New Search’ on the ‘Simple Search Results’ page.

Advanced Search Steps

  1. From the ‘Purple Book Homepage’, click ‘Advanced Search’ found directly under the search box, to search for additional product information.
  2. The Advanced Search allows you to include multiple words, data, and product information in the search box by using a space between each search criteria. For example, you may include multiple proprietary names, proper names, and strengths, such as Nexsymeo replicimab-cznm 300 400.
  3. The table below the search box will begin to populate with potential results based on what you are typing. The table will update in real-time and display all products that match any of the terms entered.
  4. Each column of the table can be sorted by clicking on the column title or the arrows in the heading. 
  5. Click ‘Show/Hide Columns’ at the top left of the table (list icon) to view the list of column options for the table. Add or remove columns based on the desired data to be viewed. To view all columns in the table, click ‘Select all’ at the top of the list.
  6. Click ‘Additional Search Filters’ at the top left of the table (filter icon) to show the additional search filters drop-down box. The additional search filters can be used to expand your search by selecting from each drop-down list.
  7. Click on the Proprietary Name link in the table, to view the ‘Product Details’ page for a specific product.
  8. To view the current label, click on the ‘Product Label’ icon/link. This will bring up a new window to the product’s landing page within Drugs@FDA for CDER regulated products or the National Library of Medicine’s DailyMed website for CBER regulated products. For products where a label is not available (e.g., revoked products) the 'Product Label’ icon/link will not be active.
    • Within Drugs@FDA, click the ‘Labels for BLA’ header and click the most recently dated ‘Label’ hyperlink to view the current prescribing information or labeling (e.g., Medication Guide, Instructions for Use, etc.).
    • Within DailyMed, the link will go directly to the label or the search results page if there are multiple labels for a product.
  9. To view patent list information for certain licensed biological products where patent list information has been provided, click ‘Show/Hide Columns’ at the top left of the table (list icon) and select ‘Patent List Provided.’ Clicking the ‘Yes’ link in this column will bring up the ‘Patent List’ page.
  10. To change the number of rows shown per page, select the number you would like to show from the drop-down list at the top right of the table. To view all rows, select ‘All’ from the drop-down list.
  11. To download the search results, click the ‘Export data’ option (download icon) at the top left of the table. From the drop-down list, select ‘CSV’, ‘MS-Excel’, or ‘PDF’ based on the desired format of the downloaded data. The selected columns and applicable data will be included in the downloaded versions. To print or save the page, click ‘Print’ at the top left of the table (printer icon).
  12. To clear all previously entered text/filters and begin a new search, click ‘Reset’ at the top of the page.

Download Purple Book Data Steps

  1. From the ‘Purple Book Homepage’, click ‘Download Purple Book Data’ on the navigation bar to view monthly reports of Purple Book data.
  2. The reports contain any changes in product data for the selected month and the entire contents of the Purple Book for that month. The monthly reports can be downloaded in CSV or XLSX formats.
  3. To view monthly reports for previous years, click the archive folder to view the drop-down list of monthly reports for the desired year (e.g., 2020 Data Downloads Archive).
  4. Select the ‘CSV’ or ‘XLSX’ file link for the desired month.
    • Each monthly report is divided into two sections. The top section of the report lists the changes that occurred during that month in three different categories: updated products (U), newly approved products (N), and products added in current release (R). Updated products (U) include FDA-approved products previously in the Purple Book that experienced changes during the month, resulting in an update of the applicable product(s) information (e.g., change in applicant or proprietary name). Newly approved products (N) include those that received initial FDA-approval during the month. Products added in current release (R) include a set of products that are not newly approved but were not previously included in the database. For example, some already-approved biologic products that were regulated by the Center for Biologics Evaluation and Research (CBER) were added for the first time to the Purple Book as part of an August 2020 database release to include all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER. The monthly report for August 2020 begins by listing each of those products added as part of the release followed by a listing by BLA number of all products in the Purple Book for that month (starting at Row 1100 in the August 2020 report).
  5. Users can also download all current Purple Book product information from the Advanced Search page. See ‘Advanced Search Steps’ for additional details.

Download Patent List Steps

  1. From the ‘Purple Book Homepage’, click ‘Patent List’ on the navigation bar to view information about patents listed in Purple Book and the table of patent information provided for certain licensed biological products. The ‘Patent List’ page can also be accessed from the ‘Product Details’ page by clicking ‘Yes’ under ‘Patent List Provided’, if applicable. For additional information about the requirement for FDA to publish patent information for certain licensed biological products, see FAQ 5.
  2. The table includes patent information and corresponding expiry dates for certain licensed biological products.
  3. Each column of the table can be sorted by clicking on the column title or arrows in the heading of each column.
  4. The patent list table has two display options – row view and card view. The default table shows the patent information in row view. To switch to card view, click the ‘Show/Hide card view’ toggle icon at the top left of the table.
  5. Click ‘Show/Hide Columns’ at the top left of the table (list icon) to view the list of column options for the table. All columns are included in the table by default and users may unselect columns if desired.
  6. To download the patent information table, click the ‘Export data’ option at the top left of the table (download icon). From the drop-down list, select ‘CSV’, ‘MS-Excel’, or ‘PDF’ based on the desired format of the downloaded data. The selected columns and applicable data will be included in the downloaded versions. To print or save the page, click ‘Print’ at the top left of the table (printer icon).