Frequently Asked Questions on The Orange Book
1. How often is the Orange Book updated?
Since February 2005, we have been providing daily Electronic Orange Book (EOB) product information for new generic drug approvals. Daily generic updates provide the consumer with the current list of approved generic products which is important for substitution purposes. Previously, a first-time-generic product approved early in the month would not be published in the EOB for several weeks.
The monthly EOB update goal is by the end of the following month’s second work week (e.g., November’s EOB will be updated by the end of the second full work week in December).
The EOB content includes:
- New Drug Application (NDA) approvals in the EOB month they were approved. NDA application numbers are preceded with “N”
- Abbreviated New Drug Application approvals (ANDA or Generic) as of the date of the daily update. Generic application numbers are preceded with “A”.
- All product changes received and processed as of the monthly update date.
(Discontinued products will be processed as of the date of publication. There will be circumstances where a product is discontinued in one month, however, it will be reported in a different month's EOB. For example, the Orange Book Staff received a letter November 7 that the product has been discontinued from manufacturing and marketing. The Orange Book subsequently updates the October EOB on November 14. The product will show in the October EOB that it is discontinued even though the date of discontinuance is the day that the Orange Book Staff receives notification (November 7)).
- Patent information, also updated daily in the EOB, as of the date of the daily update.
- Exclusivity information updated monthly and current to the date of the monthly EOB update date.
2. How do I obtain the Orange Book?
Commencing with the 25th edition, the Annual Edition and monthly Cumulative Supplements have been provided in downloadable Portable Document Format (PDF) at the EOB home page by clicking on Annual Edition. The PDF annual and cumulative supplements duplicate previous paper versions. Over time, there will be an archive for the annuals and each year's December Cumulative Supplement.
The downloaded Annual Edition and Cumulative Supplements are also available in a paper version (Approved Drug Products with Therapeutic Equivalence Evaluations, ADP) from the U.S. Government Printing Office: http://bookstore.gpo.gov/ ; toll free 866-512-1800/
There are ASCII text files of the Orange Book drug product, patent, and exclusivity data at the Orange Book Information Data Files page. The text files are provided in eobzip.exe and eobzip.zip format. The files are updated concurrently with the monthly cumulative supplements. Also, the annual Orange Book Edition Appendices A, B, and C in PDF format are updated quarterly.
3. How Do I use the Electronic Orange Book to find approved generic drugs?
First, if you have the trade name, search the Electronic Orange Book Rx or OTC section using the Proprietary Name search. This determines the ingredient(s). Then use the Ingredient Search for all approved products that contain the ingredient(s). The resulting list will provide approved products by dosage form and route.
For each dosage form; route grouping, there will be a Reference Listed Drug (RLD) that is the innovator product. One or more strengths will have a Yes RLD. If there are approved generic products of another firm, the RLD will be No and all the products within the dosage form; route grouping will have a therapeutic Equivalence Code (TE Code). Products that have been discontinued are in the Discontinued Section and do not RLD or TE Codes. The OTC Section products are not evaluated for therapeutic Equivalence.
Refer to the EOB home page preface for discussion and definitions of the TE Code and Reference Listed Drug (RLD). There is also a link on the query column headings which will link to the definition of these terms.
4. I want drug information not found in the Orange Book. How do I go about getting it?
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 Freedom of Information Staff at:
Food and Drug Administration
Freedom of Information Office, HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 827-6500
The CDER Freedom of Information Office Electronic Reading Room also has additional information available.
A Handbook for Requesting Information and Records from FDA is also available.