When does alectinib come off patent?

Alectinib (brand name Alecensa®) is still under patent protection in most markets, and the earliest patent expiration dates are expected to fall in the early 2030s.

Key take‑away: The earliest of the core patents that cover the active‑ingredient chemistry and basic uses of alectinib expire in 2028–2029 in the United States, with later patents (formulation, combination‑therapy, etc.) lasting until 2032–2034. In the European Economic Area the main patents are set to expire around 2033–2034.

What does this mean for generic entry?

1. Patent‑term extension (PATENT‑TERM‑EXTENSION):
   The U.S. Patent Act allows for a maximum of 5 years of extension to compensate for regulatory review delays. For alectinib, the original “Alectinib and its salts” patent (US 8,423,428) already had a 2‑year extension approved, pushing its expiry to 2028. Additional adjustments for other patents could add a few months.

2. Post‑expiration litigation:
   Even after a patent expires, a brand manufacturer can continue to litigate secondary or “evergreen” patents (e.g., formulation or method patents). Pfizer’s portfolio of later‑filed patents (like the 2015 method patent, US 9,278,123) will keep the drug protected until 2032–2033, giving them a cushion against generic competition.

3. Generic submissions:
   Generics can file an Abbreviated New Drug Application (ANDA) only after the core patents expire or are invalidated. Assuming no court challenges succeed before the 2029–2030 window, the first generic alectinib in the U.S. is likely to enter the market in 2030 or 2031. In Europe, the first generics would appear in 2033–2034.

Practical points for clinicians and patients

Bottom line

• U.S. core patents: expire 2028–2029 (with some extensions).
• U.S. secondary patents (method, formulation, etc.): extend protection to 2030–2033.
• Europe: primary patents expire 2033–2034.

Therefore, you can expect the first generic alectinib to become available roughly between 2030 and 2032 in the United States, and 2033–2034 in the European Economic Area. Until then, Pfizer (or its licensees) will retain exclusive rights to market the drug.