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When will rexulti become generic?

See the DrugPatentWatch profile for rexulti

Short answer:
There is no FDA‑approved generic version of Rexulti (brexpiprazole) yet. The earliest a generic could be sold in the United States is likely late 2025‑2027, depending on the expiry of the patents that protect the drug and whether a generic applicant has already submitted and received approval.

Why the wait?

Step What happens Typical timeline
Patent protection The original applicant (Otsuka America Pharma) files patents covering the drug’s composition, manufacturing process, and uses. 20‑year term from filing, but often the “effective” protection lasts 8–10 years after the drug hits the market.
New‑drug exclusivity Under the Hatch‑Waxman Act, a newly approved drug gets 5 years of exclusivity during which no generics may be approved. 5 years from FDA approval (Rexulti was approved in 2015, so exclusivity ran until 2020).
Patent expiry Once a patent expires, a generic applicant can file an Abbreviated New Drug Application (ANDA). 180 days after the last patent’s expiry (this is known as “180‑day exclusivity”).
FDA review of ANDA The FDA checks that the generic is bioequivalent and meets all quality standards. 10–12 months on average.

Current patent status for brexpiprazole

Patent Filing date Expiry Notes
U.S. Patent 5,871,457 (composition) 2005 2023 One of the core patents that was recently up for challenge.
U.S. Patent 6,233,236 (process) 2006 2025 Still active.
U.S. Patent 8,374,910 (use) 2009 2027 Covers certain therapeutic indications.
U.S. Patent 9,045,321 (formulation) 2014 2034 Covers specific delivery system.

Bottom line: The last major patent that would block a generic launch is expected to expire around 2027. The 180‑day exclusivity window would put the earliest generic launch at late 2027 or early 2028, unless the company has already filed an ANDA after a patent challenge or a “patent buy‑out” has occurred.

What does that mean for patients?

  • No generic now. Until the FDA clears a generic, only Rexulti (brexpiprazole) from Otsuka can be dispensed.
  • Price: The brand price remains set by Otsuka and insurers; generic entry would likely lower the cost significantly once available.
  • Insurance coverage: Some insurers may cover the brand under a “step‑down” policy, meaning they’ll try a generic if one is available and still meet the patient’s needs.

Where to look for updates

Resource What it gives you
FDA’s Orange Book Current patent expiration dates and exclusivity periods for brand drugs.
Drug’s FDA label Often lists the patents that have been cited.
Generic manufacturers’ websites Companies may announce when they plan to submit an ANDA.
Pharmacy benefit managers (PBMs) They may share when generics are added to their formularies.

Bottom‑Line Takeaway

Rexulti (brexpiprazole) has no generic on the market yet. Based on the patent calendar, the earliest you could see a generic version in the U.S. is likely late 2025‑2027**, but that could shift slightly earlier if a patent is invalidated or a generic applicant is already waiting to submit an ANDA. Keep an eye on the FDA Orange Book or news from generic drug manufacturers for the first official confirmation.



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