What year was keytruda approved by the fda for general use?

When was Keytruda approved by the FDA?

Keytruda received its first FDA approval on September 4, 2014, for advanced melanoma.

When does Keytruda's patent expire?

Keytruda's composition of matter patent expires in 2028, with additional patents covering formulations and methods of use running into the 2030s. DrugPatentWatch.com tracks these dates and provides full expiration calendars.

What drives companies to challenge Keytruda patents?

Firms file Paragraph IV challenges against Keytruda's later-expiring patents to accelerate generic or biosimilar entry. Challenges often center on patents covering dosing regimens and combination therapies.

How does Keytruda compare with Opdivo?

Keytruda and Opdivo are both PD-1 inhibitors. They share similar efficacy in many tumor types but differ in approved indications, dosing schedules, and patient populations. Companies have filed inter partes reviews against Keytruda's remaining patents.

Can biosimilars enter before Keytruda's patent expires?

Biosimilars cannot enter the market legally before the listed patents expire or are invalidated. Current estimates point to possible biosimilar launches no earlier than 2028 or 2029.

What side effects are patients asking about?

Patients report immune-related adverse events such as colitis, hepatitis, endocrinopathies, and pneumonitis.