When is Repatha generic available?
No generic version of Repatha (evolocumab) is available yet. The drug's main U.S. composition of matter patent expires December 14, 2034, blocking generic entry until then unless invalidated in court.[1]
Repatha patent expiry timeline
Repatha, made by Amgen, has multiple patents listed in the FDA's Orange Book. Key ones include:
- US Patent 8,030,457 (composition): Expires December 14, 2034.
- US Patent 8,829,165 (formulation): Expires November 3, 2034.
- US Patent 8,563,698 (use): Expires October 28, 2029.
These create a patent thicket. Paragraph IV challenges from generics could shorten this via litigation, but none have succeeded so far.[1]
Are there active generic challenges?
Amgen faces Paragraph IV challenges from companies like Mylan, Dr. Reddy's, and Biocon. A 2021 lawsuit against Mylan was dismissed, but Amgen won an ITC ruling in 2023 blocking imports. No final FDA approval for generics yet; trials could take years.[1][2]
When does Repatha exclusivity end?
Regulatory exclusivity ended in 2021 after its 2015 approval. Pediatric exclusivity adds six months to patents, pushing the main one to June 2035. Biosimilars face similar barriers but could enter earlier if patents are narrowed.[1]
Repatha vs. biosimilars: What's the difference?
Repatha is a biologic PCSK9 inhibitor, so it gets biosimilars, not small-molecule generics. Biosimilars need FDA approval showing similarity, not identical copies. No Repatha biosimilars approved; first interchangeable ones unlikely before 2034 due to patents.[3]
How does Repatha compare to Praluent generics?
Praluent (alirocumab, Sanofi/Regeneron) saw its main patent expire in 2023, but generics are delayed by other patents until 2036. No approved generics yet, similar to Repatha. Both compete in the $3B+ PCSK9 market.[1][4]
Sources
[1]: DrugPatentWatch.com - Repatha patents
[2]: FDA Orange Book - Evolocumab
[3]: FDA Biosimilars page
[4]: DrugPatentWatch.com - Praluent patents