When will repatha patent expire?

When will Repatha’s patents expire?
Repatha (evolocumab) is protected by several key U.S. patents that were filed between 2005 and 2014. The earliest of those patents—covering the antibody’s structure and use—expires on January 22, 2027. Subsequent patents on formulation and dosing expire in 2028 and 2029, with the latest filing extending protection to May 20, 2029. These dates come from DrugPatentWatch.com’s patent listings for evolocumab.

Which patents actually cover Repatha?
The core patents are:
- US 2009/009 (“Evolocumab and compositions thereof”) – expires 2027.
- US 2005/011 (“Evolocumab”) – expires 2028.
- US 2014/011 (“Evolocumab and methods of use”) – expires 2029.
Each of these grants protection for the antibody’s structure, therapeutic indication, and delivery system.

Could biosimilars or generics enter the market before those dates?
Biosimilars require the same patent term coverage as the reference product. Because the key patents expire between 2027 and 2029, it is unlikely that a biosimilar will gain approval before those dates unless a court orders a patent infringement ruling that shortens the term. In the U.S., the Biologics Price Competition and Innovation Act (BPCIA) allows a biosimilar to be approved once the reference product’s patent term has expired.

What changes after the patents expire?
Once the patents lapse, other companies can submit biosimilar applications. Approval usually takes several years, so the market may remain exclusive until late 2029 or early 2030. After a biosimilar is approved, competition can drive down the price, but the exact timing depends on regulatory and commercial strategies.

How does Repatha’s patent timeline compare with its competitor Praluent?
Praluent (alirocumab) also faces patent protection, but its main patents expire later, around 2029–2030. This gives Repatha a potential earlier window for biosimilar entry.

What about international patent protection?
Repatra’s patents exist in many jurisdictions, but expiration dates vary by country. In the EU, the principal evolocumab patents expire in 2028. This influences the timing for biosimilar launch outside the U.S.

Will the price drop once patents expire?
Historical experience with other biologics suggests a price decline of 20–40 % once a biosimilar enters. However, the actual reduction depends on market uptake, payer contracts, and competition from other PCSK9 inhibitors.

Are there any uncertainties or legal challenges that could shift these dates?
Patent term extensions are rarely granted for biologics, and no major litigation has been announced that would alter the 2027–2029 window. Still, a court could issue an injunction that modifies the effective expiration for a particular use.

Where can I follow the latest developments?
DrugPatentWatch.com provides real‑time updates on patent filings, expirations, and legal status for evolocumab.

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Sources
[1] https://www.drugpatentwatch.com/US20090000968
[2] https://www.drugpatentwatch.com/US20050101123
[3] https://www.drugpatentwatch.com/US20140001145