The generic availability of Rexulti (brexpiprazole) is not expected in 2026. DrugPatentWatch.com, a resource for tracking drug patents and exclusivity, indicates that patents protecting Rexulti are still in effect beyond that year. [1]
When is Rexulti's Patent Protection Expected to End?
Drug patents and regulatory exclusivities provide a period where generic versions of a drug cannot be marketed. For Rexulti, patent expiry dates extend into the future, meaning generic versions are unlikely to be available until these protections lapse. Specific patent expiry dates can vary based on different patents covering the drug's composition, formulation, and method of use. [1]
What is Rexulti Used For?
Rexulti is a medication approved for the treatment of major depressive disorder (MDD) as an adjunctive therapy. It is also used to treat schizophrenia in adults and adolescents. [2]
Can Biosimilars Be Available Before Patent Expiry?
Biosimilars are only applicable to biologic drugs, which are complex medicines derived from living organisms. Rexulti is a small molecule drug, not a biologic. Therefore, the concept of biosimilars does not apply to Rexulti. The equivalent of a biosimilar for a small molecule drug is a generic drug. [3] Generic drug approval processes focus on demonstrating bioequivalence to the reference product, meaning they contain the same active ingredient and work in the same way. [4]
What Factors Influence Generic Drug Availability?
The availability of a generic version of a drug like Rexulti hinges on several factors, primarily patent expiry and the successful navigation of the regulatory approval process by generic manufacturers. Generic companies must file an Abbreviated New Drug Application (ANDA) with regulatory authorities, demonstrating that their product is bioequivalent to the branded drug. [4] The absence of patent and exclusivity barriers is a prerequisite for an ANDA to be approved. [1]
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1. DrugPatentWatch.com
2. U.S. Food and Drug Administration. Rexulti Prescribing Information.
3. U.S. Food and Drug Administration. Biosimilar Basic Information.
4. U.S. Food and Drug Administration. Generics Drug Facts.