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Can you name the year of keytruda's first fda approval?

See the DrugPatentWatch profile for keytruda

When did Keytruda first receive FDA approval?
Keytruda received its first FDA approval in September 2014 for advanced melanoma.

How did Keytruda expand after that initial approval?
The drug later gained clearance for non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and urothelial carcinoma. Subsequent approvals also cover microsatellite instability-high cancers, tumor mutational burden-high cancers, and as adjuvant therapy in several tumor types.

What happened to Keytruda’s patents?
Keytruda’s composition-of-matter patent expires in 2028, with additional patents covering formulations and methods of use stretching into the 2030s.

Why are companies challenging this patent?
Biosimilar developers have filed IPR petitions and court challenges against Keytruda’s patents, seeking early entry once the main patent expires in 2028.



Other Questions About Keytruda :

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