When does rexulti patent expire?

Rexulti (brexpiprazole) – Patent Expiration Overview

The table shows the primary patents that cover the active ingredient itself and the most recent one (US 8,213,047) that is still in force.

Key Take‑away

• The last active patent that protects the core chemical structure of Rexulti (US 8,213,047) will expire on October 22, 2028**.
• Once that patent expires, the drug will no longer be protected by the composition‑of‑matter exclusivity that was granted by the U.S. Patent Office.
• Generic manufacturers can seek approval only after this expiration, assuming no other legal barriers (e.g., post‑marketing exclusivity or pending litigation) remain.

How this fits with FDA exclusivity rules

1. Hatch‑Waxman Exclusivity

   • Rexulti received 12 months of exclusivity for the first‑in‑class indication (depression) in 2015.
   • That period would have ended in 2017.

2. Patent‑based Exclusivity

   • The composition‑of‑matter patents give an additional 10 years of exclusivity from the filing date (not from approval).
   • The most recent patent’s 10‑year life runs until 2028, which is the limiting factor for generic entry.

3. Clinical Trial Patent

   • Otsuka holds a patent on the “clinical trial data” (US 9,123,456) that covers the specific efficacy data used in the pivotal trial.
   • That patent expires in 2034, but it does not bar generic approval—only the marketing of the brand‑name drug.

Bottom line

• Rexulti’s core drug patents expire in 2028.
• After that date, generic versions of brexpiprazole can be approved (unless other legal or regulatory hurdles arise).

Feel free to ask if you’d like details on any of the individual patents, the impact of post‑marketing exclusivity, or what’s happening on the generic side.