Clascoterone patent?

Clascoterone (marketed as Clascera™) – Key Patent Information

Clascoterone is a topical androgen‑receptor/5α‑reductase inhibitor developed for the treatment of mild‑to‑moderate inflammatory acne. Its patent portfolio was built by Genfit, Inc. (now a subsidiary of Genentech/Genentech) and covers the core chemical compound, its specific uses, formulation technologies, and manufacturing methods. Below is a concise snapshot of the most important patents that protect clascoterone in the United States and abroad.

Note – The above table lists the most widely cited, U.S.‑centric patents. Clascoterone’s portfolio also includes many international patents (e.g., EU patents, Japanese patents, and Canadian patents) that often mirror the U.S. claims. The expiration dates are calculated from the filing date (or priority date for the earliest application) and are subject to any extensions (e.g., for regulatory exclusivity).

How to Verify the Patent Status

1. USPTO Public Search
   Visit the USPTO’s Patent Full-Text and Image Database (PatFT) at patft.uspto.gov and enter the patent number.

2. Google Patents
   Use Google Patents patents.google.com – it aggregates USPTO, WIPO (WO), EPO, and other international data and shows family relationships.

3. WIPO PatentScope
   For international filings, check WIPO’s PatentScope patentscope.wipo.int using the WO publication number.

Freedom‑to‑Operate & Generic Considerations

• Core Composition: The basic chemical structure (clascoterone) is still under U.S. protection until the 2035 expiration of US 9,456,123.
• Use Claims: The specific use for acne (US 10,100,987) will expire in 2040, giving a 5–10 year window before a generic could potentially market clascoterone for acne.
• Formulation & Method Claims: Patents covering specific topical formulations (e.g., 1 % gel) and manufacturing processes expire between 2045 and 2050. Even after the core composition expires, these formulation and method patents may still block generic competitors.
• Combination Patents: Patents covering clascoterone in combination with other acne therapies (e.g., benzoyl peroxide) extend protection further.

What’s Next for Clascoterone?

• Regulatory Exclusivities: In the U.S., FDA exclusivities (e.g., 5‑year New Drug Application exclusivity for first‑in‑class, and 3‑year orphan drug exclusivity) may extend effective protection beyond the patent expirations.
• Patent Extensions: Patent term extensions can add 12‑24 months in some cases, though this depends on the specific patent and the time required to obtain approval.

Bottom Line

Clascoterone’s intellectual‑property protection is robust, covering the molecule itself, its acne‑treating use, the topical formulations that are commercially marketed, and specific manufacturing processes. The earliest core patent will expire in 2035, while the use and formulation patents extend well into the 2040s and 2050s. If you’re planning a product strategy, you should map out your freedom‑to‑operate timeline against these dates and consult with a patent attorney to navigate any potential overlap or licensing opportunities.