Drybench Patent.
Patents vs FDA exclusivity: how they differ
A product can carry many dates: patents its sponsor listed and exclusivities FDA applies. They come from different places and bar different things, which is why the app shows them as a range, each traced to FDA's rows, rather than as one date.
FDA capture · review pending. These pages summarise the statute, the regulations and FDA's own pages as read on the date given with each source. The statute is read from the US Code 2023 edition; later amendments have not been checked. They have not been independently reviewed by a regulatory-affairs reviewer.
Explanations of the FDA files and of the statute and regulations as written: not a forecast of market entry and not legal, regulatory or investment advice.
Where each comes from
The application holder submits patent information to FDA, and only drug substance, drug product and method-of-use patents may be listed (21 CFR 314.53(b)(1)). The listed patent date is the holder's figure, including extensions, and FDA does not change disputed patent information unless the holder withdraws or amends it (21 CFR 314.53(f)(1)).
Exclusivities are periods in which FDA does not accept or approve certain competing applications, set by statute and applied by FDA (21 CFR 314.108(b); 21 CFR 316.31(a); 42 USC 262(k)(7)).
What each kind governs
Some exclusivities bar submission: the five-year new chemical entity period (21 CFR 314.108(b)(2)) and the four years for a biosimilar application (42 USC 262(k)(7)(B)). Others bar approval: the three-year period for new clinical investigations (21 CFR 314.108(b)(4), (5)), seven-year orphan exclusivity (21 CFR 316.31(a)) and the 12 years for a reference biologic (42 USC 262(k)(7)(A)).
Several are narrow. Three-year exclusivity on a supplement bars approval for that change (21 CFR 314.108(b)(5)); orphan exclusivity bars the same drug for the same use or indication (21 CFR 316.31(a)); and for a method-of-use patent an applicant can, instead of certifying, state that the patent does not claim the use it is seeking approval for (21 USC 355(j)(2)(A)(viii)). One date can therefore cover part of a product and not the rest.
Pediatric exclusivity extends by six months certain periods attached to exclusivities, whether they bar submission or approval, and the period in which FDA may not approve an application because of certain listed patents (21 USC 355a(b)(1)(A), (B)); it does not lengthen the patent itself.
Why two FDA sources can differ
FDA's Paragraph IV list gives an expiration date for the last qualifying patent that does not reflect pediatric exclusivity, while the Orange Book lists a *PED row with its own later date. The two dates describe different things.
The files do not record lawsuits, their outcomes or settlements, or how a first applicant's 180-day period stands beyond what FDA's list states.
How the app shows them
Every listed date is shown with the rows it rests on and the rule that reads it, and the summary is a set: the latest substance patent, the latest listed patent of any kind, the latest exclusivity, and the earliest and latest of all the dates. The app gives no single date for a product.
See it in the app
Open a product's Protection view to see every listed date traced to its rule and FDA's row, and the summary shown as a set of dates.
Sources
- 21 CFR 314.53, Submission of patent information, as of 1 October 2026. eCFR, read 31 October 2026
- 21 CFR 314.108, New drug product exclusivity, as of 1 October 2026. eCFR, read 31 October 2026
- 21 CFR 316.31, Scope of orphan-drug exclusive approval, as of 1 October 2026. eCFR, read 31 October 2026
- 42 USC 262, US Code 2023 edition (regulation of biological products). govinfo, read 31 October 2026
- 21 USC 355a, US Code 2023 edition (pediatric studies of drugs). govinfo, read 31 October 2026
- US Food and Drug Administration. Patent Certifications and Suitability Petitions (the Paragraph IV list page), content current as of 30 October 2026. FDA, read 31 October 2026
- US Food and Drug Administration. Orange Book Data Files, content current as of 18 August 2026. FDA, read 31 October 2026