Orange Book Patent and Exclusivity Expiry

Every date here is a date in FDA's Orange Book: the day a listed patent or a listed exclusivity ends. It is not the day a generic reaches the market, and it says nothing about sales. Several things move the real date.

• Extensions. FDA's patent dates already include patent term extensions. Pediatric exclusivity adds six months to existing patents and exclusivities, and FDA lists the patent a second time with the later date. This page counts both dates, so a drug's last listed date includes the pediatric six months where FDA lists them.
• Patents that are not listed. NDA holders list drug substance, drug product and method-of-use patents under 21 CFR 314.53. Process patents are not eligible, so a company can hold patents that run longer than anything listed. The Orange Book vs Purple Book guide covers the limits of both lists.
• Challenges and litigation. A generic applicant can certify that a listed patent is invalid or not infringed. If the patent owner sues within 45 days, FDA approval can be held for up to 30 months, or a shorter or longer period a court orders, under section 505(j)(5)(B)(iii) of the FD&C Act. The first applicant to file such a challenge can earn 180 days of exclusivity. Settlements often set an entry date that appears nowhere in the Orange Book.
• Method-of-use patents. A generic can leave a patented use out of its label by saying so in its application, and launch for the other uses. A listed use patent does not always block a launch.
• Delisted patents. A sponsor can ask FDA to delist a patent. FDA keeps it listed, flagged, while a first generic applicant could still earn 180-day exclusivity from challenging it. We count those dates.
• Exclusivity is separate from patents. FDA lists exclusivity such as 5-year new chemical entity, 7-year orphan drug and 3-year new clinical investigation exclusivity. It can end before or after any patent.

For a launch date, a patent attorney needs the patents, the litigation record and any settlement. This page tells you where to start looking.

• Drugs. One row per new drug application (NDA, including 505(b)(2) applications) with at least one listed patent or exclusivity and at least one product not marked discontinued. Generic applications (ANDAs) are left out. Their only listed exclusivities are the 180-day patent challenge and competitive generic therapy codes.
• Last listed expiry. The latest date among every listed patent, patent plus pediatric extension and exclusivity for the NDA. The headline counts drugs where that date falls between today and Nov 12, 2028.
• Next listed expiry. The earliest listed date that has not passed.
• Already ended. FDA removes expired patents and exclusivities from the Orange Book. The monthly file lags, so 43 drugs in the current file have only dates that have passed. They are left out.
• Sponsors. The applicant FDA lists for the NDA. Names that differ only by a corporate suffix such as Inc or LLC are merged. Parent companies and subsidiaries are not combined, and a sponsor can hold an NDA for a drug another company discovered.
• Notable expiries. A fixed rule, not a judgement: drugs ending in the window with a listed drug substance patent or NCE exclusivity, soonest first, one per sponsor. Drug substance flags exist only for patents listed after August 18, 2003, so the list can miss older drugs.

Biologics are licensed under the Public Health Service Act and sit in the Purple Book, not the Orange Book. The Purple Book is thinner on dates. In its October 2026 data file, 36 of 2,256 product rows carry a reference product exclusivity expiration date, and 49 show a patent list. A blank does not mean there is no exclusivity or patent, so a biologics expiry table built from it would mislead. See the Orange Book vs Purple Book guide for how to read a Purple Book record.

The data comes from FDA's Orange Book data files: a zip of three tilde-delimited files for products, patents and exclusivity. FDA updates it monthly. A scheduled job on this site checks FDA daily, and when the file is new it rebuilds the table, checks that it has the expected structure and size, and only then replaces the saved copy. If FDA is unreachable or the file looks wrong, the last good copy stays. Current file: EOBZIP_2026_09.zip, 48,865 products, 22,438 patent rows, 2,421 exclusivity rows.

The same table is available as a CSV. Each NDA number links to FDA's own patent and exclusivity page for the product.

How many drugs reach the end of their listed patents and exclusivity in the next 24 months?

112 of 1,125 drugs with a listed patent or exclusivity still running have a last listed date between Nov 12, 2026 and 24 months later. 466 more have a listed date in that window but keep a later one.

Is an Orange Book expiry date the date generics launch?

No. Patent term extensions, pediatric exclusivity, patents that are not listed, litigation, settlements, method-of-use carve-outs and delisted patents all change when a generic can enter. Treat the date as a starting point for patent counsel, not a forecast.

Why is a drug I expected missing?

Biologics are in the Purple Book. Generic applications are left out. A drug with no listed patent or exclusivity has nothing to expire, and a drug whose products are all discontinued is not counted. The Orange Book also holds 5,538 applications in total, most with nothing listed.

How often is the data updated?

FDA publishes new Orange Book data files monthly. This site checks daily and rebuilds the table when FDA posts a new file.

Does this show revenue at risk?

No. The Orange Book has no sales data, and this page adds none. A listed expiry date says when a listed protection ends, not what the product earns or when its sales will change.

Can I download the table?

Yes. The button above the table downloads the current list, or the filtered list when a filter is on. The full table is also at arca.inc/tools/exclusivity-expiry/csv.