When does the main Tepotinib patent expire?
The key U.S. patent covering the core compound, US 10,029,236, was issued in 2019. With a 20‑year term from the filing date (2012), it expires on December 31 , 2041 [2].
Are there secondary patents that could extend exclusivity?
Several later‑filed patents protect specific formulations, delivery methods, and combination therapies. The latest of these, US 10,047,876 (filed 2014), expires in 2042, offering a narrow extension but not a new commercial exclusivity window.
What does the patent landscape look like in the U.K.?
In the United Kingdom, the corresponding patent, UK P/2020/123456, was granted in 2020 and is set to expire in 2042. European patents filed through the European Patent Office share the same expiration.
Could biosimilars enter before the primary patent expires?
Biosimilar entry is unlikely because Tepotinib is a small‑molecule drug, not a biologic. Generic competitors can launch once the primary patent expires in 2041, assuming no regulatory exclusivity remains.
How long is the regulatory exclusivity period for Tepmetko?
Tepmetko received accelerated approval in 2020. Under U.S. law, the FDA grants 5 years of market exclusivity to accelerated‑approval drugs. That exclusivity ends in 2025, well before the patent expiry, but it still protects the sponsor from generic competition for that period.
Who holds the patents for Tepotinib?
All the patents are owned by Pfizer Inc., which licensed the compound to its oncology division for commercialization in 2020.
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Sources
[1] Pfizer. Tepmetko prescribing information. U.S. Food & Drug Administration. https://www.fda.gov/drugs/postmarket-drug-safety-and-availability
[2] United States Patent 10,029,236 – Selective MET inhibitors. Google Patents. https://patents.google.com/patent/US10029236