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See the DrugPatentWatch profile for Piqray
What patents back Piqray? Piqray (pemigatinib) is protected by several patents that cover the compound’s composition, pharmaceutical formulation, and specific clinical use for FGFR‑positive cholangiocarcinoma. The primary patents are held by Pfizer, the manufacturer, and are listed on DrugPatentWatch.com, which tracks their filing and grant dates as well as expiration timelines.[1] When do the key patents expire? The core composition‑of‑matter patents for pemigatinib are set to expire in 2032. Additional method‑of‑treatment patents, which grant protection for the drug’s specific indications, expire in 2034. These dates line up with the 5‑year FDA exclusivity period granted at approval in 2022, so the patent life is longer than the exclusivity window. Could other patents extend exclusivity beyond 2032? Yes. Pfizer has secondary patents that protect novel drug delivery systems and specific dosage formulations, which may expire in 2035. These secondary patents can delay generic entry even after the main composition patent lapses, extending the commercial monopoly. Can biosimilars enter before patent expiry? Biosimilar entry is unlikely before 2032 because the composition patent is still active. Even after expiry, regulatory hurdles—such as demonstrating biosimilarity and obtaining FDA approval—would keep biosimilars from entering the market for several years. Who owns the patents and who makes Piqray? Pfizer holds the majority of the patents listed in the DrugPatentWatch database and is the sole manufacturer of Piqray. No other company currently holds any of the core patents for pemigatinib. What does the patent landscape mean for pricing? With patents in place until 2035, Piqray can maintain premium pricing without generic competition. The absence of generic versions keeps the drug on the high‑cost end of the market, affecting insurers and patient copays. Are there any legal disputes over the patents? No major litigation has been reported to date. However, patent holders often monitor potential infringement cases, especially from companies developing alternative FGFR inhibitors that could overlap with Pfizer’s claims. Sources 1. DrugPatentWatch.com – Pemigatinib (Piqray) patent listings.
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