Loss-of-Exclusivity Calendar

• These are patent and exclusivity EVENTS, not generic launch dates. An expiry date is the date a listed protection lapses, and nothing more.
• A generic can arrive EARLIER than the dates shown. Paragraph IV settlements between a brand and a generic applicant routinely set an agreed entry date ahead of the listed patent expiry. Those agreements are private, they are not in the Orange Book, and this calendar does not model settlement-driven launch timing because the underlying data does not contain it.
• A generic can also arrive later, or not at all. Ongoing litigation, at-risk launches, authorised generics and manufacturing or commercial decisions all move real launches, and none of that is in this data either.
• This calendar is built from the FDA Orange Book. It covers small-molecule drugs approved under an NDA or ANDA. It does NOT cover biologics, whose exclusivities are published in the FDA Purple Book — a biologic showing no events here is absent from this dataset, which is not the same as being unprotected.
• A listed patent does not mean there is no generic today. A drug with marketed generics can still carry patents covering later formulations, combinations or delivery devices — atorvastatin has a patent running to 2037 and has been generic for years.
• Approved is not marketed. A drug can have several approved generic applications and still have nothing a pharmacy can dispense, because approval and launch are separated by patent litigation and settlement terms.
• This calendar covers the patents and exclusivities recorded in the Orange Book data we hold. A drug with no listed event is not promised a generic, and coverage may be incomplete for any individual product.
• Orange Book snapshot ingested 2026-09-13.

small-molecule drugs approved under an NDA or ANDA, and the patents and marketing exclusivities the FDA lists against them. Source: FDA Orange Book — Approved Drug Products with Therapeutic Equivalence Evaluations.

• Biologics. These are licensed under a BLA and their exclusivities are published in the FDA Purple Book, which this calendar does not read. A biologic returning no events here means it is not in this dataset — not that nothing protects it.
• Settlement and litigation outcomes. Paragraph IV settlements routinely set an agreed entry date that is EARLIER than the listed patent expiry, and those agreed dates are private and are not in the Orange Book. This calendar does not model them and cannot.
• At-risk launches, authorised generics, and manufacturing or commercial decisions.