What is Repatha's current patent situation?
Repatha (evolocumab) is a medication used to treat high cholesterol and prevent cardiovascular disease. The drug was first approved by the FDA in 2015 under a partnership between Amgen and Sanofi.
According to DrugPatentWatch.com [1], Repatha's original US patent (US 9,249,237) expired on January 14, 2025. However, the patent holder, Amgen, has filed multiple continuation patents, which are expected to provide additional exclusivity for the drug.
How long will Repatha remain under patent?
As of now, Repatha's US patent will expire in January 2025. However, Amgen's continuation patents will likely extend this exclusivity period. For instance, US patent US 11,444,142, a continuation of the original patent, expires on July 7, 2041. Another continuation patent, US 11,644,141, is set to expire on October 7, 2044.
What happens after Repatha goes off patent?
When Repatha goes off patent, other companies may start developing biosimilars or generic versions of the medication. However, it's worth noting that these products will need to undergo rigorous clinical testing and regulatory approval before they can be marketed in the US.
In fact, several biosimilar versions of Repatha are already under development, including those from Biosimilar Development Group (BDG), Mylan, and Samsung Bioepis [2][3][4].
Is there competition for Repatha already?
While Repatha's patent will expire soon, competition from established rivals like Praluent (alirocumab) from Sanofi and Regeneron, as well as newer entrants, will likely continue.
Sources:
[1] DrugPatentWatch.com - Evolocumab Patent Expiration Dates
[2] Biosimilar Development Group (BDG) - BDG Submits Biologics License Application to FDA for Its Biosimilar of Repatha
[3] Mylan - Mylan Announces Launch of Its First Biosimilar, Myojo, in the US
[4] Samsung Bioepis - Samsung Bioepis Announces Submission of Biologics License Application (BLA) to the FDA for SB11, a Proposed Biosimilar to Repatha in the US