Key Semaglutide Patents and Expiry Dates
Semaglutide, the active ingredient in drugs like Ozempic and Wegovy from Novo Nordisk, has multiple patents covering the compound, formulations, and delivery methods. The core compound patent (US 8,129,343) expires in 2032 in the US.[1] A key formulation patent (US 8,536,122, listed for Ozempic) runs until December 2031, with pediatric exclusivity potentially extending it to June 2032.[2]
Patents for Ozempic Specifically
Ozempic's autoinjector and dosing patents include US 9,295,781 (expires 2032) and US 10,335,462 (expires 2034). The FDA's Orange Book lists 17 patents for Ozempic, with the latest expiring in 2036. These block generics until at least 2032.[1][2]
Patents for Wegovy Specifically
Wegovy shares the compound patent (to 2032) but has unique ones like US 10,888,588 for oral formulations (expires 2039). Overall protection extends to 2036-2039, depending on the delivery system.[1][2]
When Can Generics or Biosimilars Enter?
No generics until 2032 at earliest due to compound patent, but challenges could shorten this. Novo Nordisk faces ANDA lawsuits from Teva and others, with trials ongoing. Biosimilars might launch post-2032 if secondary patents invalidated.[1][3]
International Patent Expiries
In Europe, the compound patent expires in 2026 (EP 2,116,555), but formulation patents extend to 2031-2033. Japan sees expiry in 2032 for key patents.[1]
Why Expiry Dates Vary and Ongoing Litigation
Patents layer protections: compound first, then devices and methods. Novo has sued Mylan, Sandoz, and others over Paragraph IV challenges, delaying approvals. A 2023 settlement with some firms sets tentative 2031 entry.[3]
[1]: DrugPatentWatch.com - Semaglutide Patents
[2]: FDA Orange Book - Ozempic/Wegovy Patents
[3]: Novo Nordisk Litigation Updates