Current Status of Onglyza Generics
Onglyza (saxagliptin), Bristol Myers Squibb and AstraZeneca's DPP-4 inhibitor for type 2 diabetes, faces delayed generic entry due to ongoing patent protections and litigation. No generics are approved or available in the U.S. as of late 2024.[1]
Key Patent Expirations
The primary composition of matter patent (U.S. Patent 6,995,181) expired in 2016, but secondary patents block generics longer. The main formulation patent (U.S. Patent 8,414,955) expires July 8, 2026. Pediatric exclusivity adds six months, pushing full expiry to January 8, 2027.[2][3]
FDA Approvals for Generic Competitors
Mylan (now Viatris) won FDA approval for its saxagliptin tablet ANDA in March 2023, but entry is stayed by a patent lawsuit. A settlement reportedly allows launch no earlier than January 2027, aligning with pediatric exclusivity end.[4][2]
Impact of Ongoing Litigation
Bristol Myers Squibb sued multiple generic makers, including Mylan, over patents covering the drug's crystalline form and manufacturing. A 2023 settlement with Mylan sets the launch date post-exclusivity. Other challengers like Lupin and Aurobindo face similar hurdles, with no immediate ANDA approvals permitting at-risk launch.[3][5]
When to Expect Generics on the Market
Earliest generic availability is January 8, 2027, barring further court rulings or settlements. If additional Paragraph IV challenges succeed, limited entry could occur sooner, but current cases favor brand exclusivity.[2][3]
Pricing and Market Impact
Post-generic entry, prices could drop 80-90%, based on typical diabetes drug patterns. Brand Onglyza wholesales around $500 for a 30-day supply; generics would likely start under $50.[6]
Sources
[1]: FDA Orange Book for Onglyza
[2]: DrugPatentWatch.com - Onglyza Patents
[3]: FDA Paragraph IV Patent Challenge Tracker
[4]: Viatris Press Release on Saxagliptin Approval
[5]: USPTO Patent Litigation Database
[6]: IQVIA National Prescription Audit