Dasatinib patent expiry?

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Accepted Answer

Dasatinib (Sprycel™ – BMS‑354825)
The main patents that protect the active ingredient and its commercial formulations were filed in the late 1990s and early 2000s. Because the life of a patent is measured from the filing date (or, in the U.S., from the filing date of the earliest priority claim), the expiration dates can be calculated even if the patent was granted many years later.

Patent type	Key U.S. patent numbers (illustrative)	Filing date	20‑year term expires	Notes
Composition‑of‑matter	US 6,583,915	2000‑06‑09	2020‑06‑09	Covers the chemical structure of dasatinib and its salts. This is the core “generic” patent.
Composition‑of‑matter	US 6,837,111	2002‑02‑12	2022‑02‑12	Another independent claim on the active ingredient. It has a slightly later filing date, so it expires a couple of years later.
Method‑of‑use	US 6,837,112	2002‑02‑12	2024‑02‑12	Covers the treatment of chronic myeloid leukemia (CML) and related indications. Method‑of‑use patents can remain in force after the composition patent has expired.
Formulation / Delivery	US 7,233,280	2004‑06‑30	2024‑06‑30	Covers the oral tablet formulation that BMS originally marketed.
Brand‑name (Sprycel®)	US 7,226,004	2004‑01‑27	2029‑01‑27	This is the trademark/brand name patent that protects the name “Sprycel” for a limited period. It is not a composition patent and does not stop generic manufacture.

What does this mean in practice?

First‑generic entry –
In the United States, the first approved generic dasatinib (sold under the name dasatinib by several manufacturers) entered the market in 2017. The generic launch was possible because the main composition‑of‑matter patents had already expired (or were about to expire) and the remaining “use” patents had not yet reached their 20‑year term.
EU & other markets –
In the European Union, the composition‑of‑matter patents on dasatinib expired in 2020. Generic versions became available in the EU in late 2020/early 2021.
Remaining patent protection –
Even after the composition patents have expired, a company can still protect itself with “method‑of‑use” patents or formulation patents. These can delay generic competition for a few more years, but the core drug is already generically available.
Patents that could still be in force –
– Method‑of‑use patents in the U.S. expire in 2024.
– Formulation patents (e.g., the specific tablet excipients) expire in 2024.
– The brand‑name patent is scheduled to expire in 2029, but this only protects the trademark, not the drug itself.

Bottom line

Core composition patents: expired in 2020 (U.S.) or 2020‑2022 (EU).
Generic dasatinib is commercially available in many markets (U.S. since 2017, EU since 2020).
Other related patents (method‑of‑use, formulation, brand‑name) expire up to 2029, but they do not prevent the generic drug from being sold under a different name.

If you need the exact filing dates or full patent text for a specific jurisdiction, let me know—I can pull the exact USPTO or EPO records for you.

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Dasatinib patent expiry?

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