public-service · FDA Orange Book update cadence
Why the FDA Orange Book Shows Several 'Current' Dates
The Orange Book's own governing supplement lists four different update cadences, not one single "current as of" date.
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Updated: Sources: 2

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What matters now
- The live Orange Book query interface currently displays "Current through September 2026" on its own page.
- Generic drug (ANDA) approval data has been added to the Electronic Orange Book daily since February 2005.
- Patent information is also updated daily in the Electronic Orange Book, current to its date of publication.
- Exclusivity information is updated monthly and is current as of its date of publication.
- The annual edition's Appendices A, B, and C (PDF format) update quarterly; the Cumulative Supplement targets a monthly publish goal.
The FDA’s Orange Book — officially Approved Drug Products with Therapeutic Equivalence Evaluations — does not update on one schedule. According to the publication’s own governing Cumulative Supplement document, generic (ANDA) approval data and patent information refresh daily, exclusivity information refreshes monthly, the annual edition’s PDF appendices refresh quarterly, and the Cumulative Supplement itself targets a monthly publishing goal. Separately, the live online query tool displays its own single “Current through” stamp, which reflects that tool’s own update, not every part of the underlying publication.
This original record-reading guide is a general reading aid, not cited evidence. It does not depict a source record; the article text and source links provide the facts.
Key points
- The live Orange Book query interface displays “Current through September 2026” on its own page (FDA query tool).
- The supplement says generic-drug (ANDA) approval data has been added to the Electronic Orange Book daily since February 2005 (FDA supplement).
- Patent information is updated daily in the Electronic Orange Book and is current to its date of publication (FDA supplement).
- Exclusivity information is updated monthly and is current as of its date of publication (FDA supplement).
- The annual edition’s Appendices A, B, and C (PDF format) are updated quarterly, while the Cumulative Supplement has a monthly publishing goal (FDA supplement).
Live query date stamp
Readers who open the FDA’s online Orange Book search tool see one timestamp at the top of the page: “Current through September 2026” (accessdata.fda.gov). That single stamp sits alongside a separate governing document — the Cumulative Supplement — that describes several different cadences running underneath the same named publication.
Daily approval data
The Cumulative Supplement states: “Since February 2005, we have been providing daily Electronic Orange Book (EOB) product information for new generic drug approvals” (fda.gov/media/72973). Patent listings use the same daily cadence: “Patent information, also updated daily in the EOB, is current to the date of publication” (fda.gov/media/72973).
Monthly: exclusivity data
Exclusivity information — a separate category from patents — runs on a slower, monthly cadence: “Exclusivity information is updated monthly and is current as of the date of publication” (fda.gov/media/72973).
Quarterly: the annual edition’s PDF appendices
The print-style annual edition sits on the slowest cadence of the four. The governing document states: “The annual Orange Book Edition Appendices A, B, and C in PDF format are updated quarterly” (fda.gov/media/72973).
The Cumulative Supplement’s own publishing goal
The monthly Cumulative Supplement does not claim to post the moment a month ends. Its stated target is: “The CS monthly update publish goal is by the end of the following month’s second work week (e.g., November’s supplement will be updated by the end of the second full work week in December)” (fda.gov/media/72973).
What this article does not answer
This article explains, in the governing document’s own words, that the Orange Book runs on at least four different update cadences at once — daily, monthly, monthly, and quarterly — rather than a single refresh schedule. It does not say which of these cadences applies to any specific entry a reader happens to be viewing on a given day, since that depends on which part of the publication (electronic generic/patent data, exclusivity data, the annual edition’s PDF appendices, or the Cumulative Supplement itself) the reader is looking at and when the FDA last completed that particular update. It also does not describe or characterize the substance of any drug listing, therapeutic-equivalence code, or product entry in the Orange Book — only the publication’s own documented update mechanics.