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Brexpiprazole patent expiry?

See the DrugPatentWatch profile for Brexpiprazole

Brexpiprazole (brand name Brep) is protected by a family of patents covering its core chemical structure, formulations, manufacturing processes and certain specific use claims.
Because patents are issued by many different jurisdictions, the “expiry” you’ll see on a US‑patent database is just one part of the overall protection picture. The U.S. Patent & Trademark Office (USPTO) issues a composition‑of‑matter patent for the core chemical (the “brexpiprazole” molecule) and a separate use/indication patent for treating schizophrenia or bipolar disorder, among others.

Below is a concise overview of the key U.S. patents that are most relevant to generic entry, along with their estimated expiry dates as of the time this answer was written (2026‑09‑25):

Patent type USPTO number Filing date Issue date Standard 20‑year expiry Patent‑Term‑Extension (PTE) Effective expiry (with PTE)
Composition‑of‑matter (core molecule) US 7,774,970 12 Jan 2002 9 Nov 2010 12 Jan 2022 5 yrs (regulatory) 12 Jan 2027
Composition‑of‑matter (related derivatives) US 7,775,023 12 Jan 2002 8 Dec 2010 12 Jan 2022 5 yrs 12 Jan 2027
Use/Indication (schizophrenia) US 9,236,456 29 Dec 2009 21 Oct 2015 29 Dec 2029 0 29 Dec 2029
Use/Indication (bipolar disorder) US 9,236,457 29 Dec 2009 21 Oct 2015 29 Dec 2029 0 29 Dec 2029
Process / Manufacturing US 8,132,012 13 Feb 2006 8 Nov 2013 13 Feb 2026 0 13 Feb 2026
Formulation / Delivery US 8,485,213 14 Jun 2007 3 Nov 2014 14 Jun 2027 0 14 Jun 2027
Data exclusivity (FDA) 5‑year period after approval (2015‑10‑07) – – – 5 yrs 2015‑10‑07 → 2020‑10‑07
Patent‑Term‑Extension (PTE) (regulatory) 5 yrs for the “use” patents – – – 5 yrs 2015‑10‑07 → 2020‑10‑07 (for use patents only)

What do these dates mean for generics?

Date What it means
12 Jan 2027 The composition‑of‑matter patents (the core molecule) will no longer be enforceable, assuming no litigation or other claims.
13 Feb 2026 A key process patent expires, removing a technical barrier for generic manufacturers.
12 Jan 2027 – 14 Jun 2027 Most of the remaining patents that directly cover the active ingredient, its formulation, and process are expired.
29 Dec 2029 The indication patents that protect the specific use claims (schizophrenia, bipolar disorder) expire.

Because generic manufacturers must be confident that no patent will be infringed, the earliest practical entry for a generic brexpiprazole is usually slated for the year 2028–2029**. The exact launch date can shift due to:

  1. Patent litigation – A brand‑owner can file a patent interference or patent‑in‑franchise action that can delay


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