Venetoclax patent expiry in india?

Venetoclax (Venclexta™) – Indian Patent Landscape & Expiry

Key take‑away: The core composition‑of‑matter patent (the 20‑year term from 2010) will expire in mid‑2026. The method‑of‑treatment and combination‑therapy patents extend the protection well into the early to mid‑2030s.

How These Dates Are Determined

1. Patent Term – Indian law grants a 20‑year term from the first filing date (not the grant date). For the composition patent, the earliest filing in India was 2006, so the term ends in 2026.

2. Patent Term Extensions – In India, the patent term restoration (PTR) is limited to a maximum of 3 years for delays caused by the Patent Office, and patent term extension (PTE) for therapeutic goods is up to 5 years if the drug was approved after the patent expired. For Venetoclax, the Indian regulatory approval (CDSCO) was in 2016; because the core composition patent expired in 2026, no PTE is applicable.

3. Data Exclusivity – India does not grant data exclusivity for small‑molecule drugs. The 5‑year exclusivity period that exists in the U.S. and EU does not apply, so generics can be launched as soon as the patents have expired and the product meets Indian regulatory requirements.

Implications for Generics

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