Is generic Cosentyx available now?
No, no generic version of Cosentyx (secukinumab) is available in the US or major markets as of 2024. The brand remains protected by active patents and regulatory exclusivity, blocking FDA approval of generics until at least the mid-2030s.[1][2]
When do Cosentyx patents expire?
Key US patents for Cosentyx, held by Novartis, extend protection through 2034-2036 for the subcutaneous formulation and specific methods of use. The primary composition-of-matter patent expired earlier, but formulation and method patents maintain exclusivity. Paragraph IV challenges from generics makers like Alvotech and Formycon are pending, with no final FDA approvals yet.[2][3]
What about biosimilars for Cosentyx?
Cosentyx is a biologic, so it faces biosimilars rather than traditional generics. No interchangeable biosimilars are approved or launched. Alvotech's AVT04 is in late-stage development with a BLA submitted to the FDA in 2024, targeting launch post-patent expiry around 2034. European filings are also underway, but no market entry yet.[2][4]
Why no generics or biosimilars sooner?
Novartis has layered patents covering the drug's delivery device (pen/syringe), manufacturing processes, and indications like psoriasis and arthritis. Ongoing litigation, including recent wins against challengers, delays ANDA/BLA approvals by 30 months under Hatch-Waxman/BPCIA rules.[2][5]
How does this compare to other biologics like Humira?
Unlike Humira, which saw multiple biosimilars launch in 2023 after patent cliffs, Cosentyx's protections are more recent and robust. Expect fewer early entrants; first biosimilars likely post-2034, similar to Stelara's timeline.[2][6]
Where to check latest patent and approval status
Track updates on DrugPatentWatch.com for Cosentyx patent expirations, litigation, and generic/biosimilar pipelines: DrugPatentWatch - Cosentyx.[2]
Sources
[1]: FDA Orange Book - Cosentyx approvals and exclusivities: fda.gov
[2]: DrugPatentWatch - Cosentyx patents: drugpatentwatch.com/p/tradename/COSENTYX
[3]: Novartis investor updates on IP: novartis.com
[4]: Alvotech pipeline: alvotech.com
[5]: USPTO patent database: uspto.gov
[6]: FDA biosimilar approvals tracker: fda.gov