When does keytruda go off patent?

When does Keytruda lose patent protection?

Keytruda loses primary U.S. patent protection in 2028. The main composition-of-matter patent covering pembrolizumab expires on 6 December 2028. Additional patents on specific indications and formulations may extend effective exclusivity beyond that date.

Why are companies already challenging this patent?

Several generic manufacturers have filed Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications against Merck’s Keytruda patents. These challenges focus on the 2028 expiration date and attempt to clear a path for earlier launch. Merck has responded by filing suit against multiple filers, keeping the process in litigation.

How long does Keytruda remain under regulatory exclusivity?

Regulatory exclusivity under the Hatch-Waxman Act runs parallel to patent life. Keytruda’s five-year new-chemical-entity exclusivity expired years ago. Its seven-year orphan-drug exclusivity for certain indications also has already expired. Remaining regulatory barriers are therefore largely patent-driven.

What happens if a generic enters before 2028?

A successful Paragraph IV challenge could produce an at-risk launch before the Hauptsache patent expires. Such launches are rare because they carry high damages risk. Merck’s ongoing litigation may push any first generic launch into 2029 or later.

Can biosimilars enter before patent expiry?

Keytruda is a biologic, so future entrants will be biosimilars rather than traditional generics. Biosimilar applicants require an abbreviated Biologics License Application (aBLA) under the BPCIA. The BPCIA’s 12-year data exclusivity for Keytruda expired in 2024, so biosimilars can now file applications. Filing, however, does not mean launch; they still must resolve patent disputes.

Who makes Keytruda and what price range does it currently command?

Merck manufactures Keytruda. Current average wholesale price exceeds $11,000 per dose, depending on patient weight. The company reported 2024 sales of roughly $25 billion.