Tigecycline Injection Patent Basics
Tigecycline, sold as Tygacil by Wyeth (now Pfizer), treats complicated skin and intra-abdominal infections. Its key U.S. patent for the injection formulation, US Patent 7,485,620, covers the composition and method of use. The base patent term expired in 2021, but pediatric exclusivity added 6 months, extending protection to July 15, 2022.[1]
How the Patent Extension Works
The extension stems from FDA pediatric exclusivity under the Best Pharmaceuticals for Children Act (BPCA). This grants 6 additional months of marketing exclusivity upon completing required pediatric studies, tacked onto the end of patents or exclusivities. For Tygacil injection, FDA granted this in 2022, pushing effective exclusivity past the patent expiry.[1][2]
Exact Duration of the Extension
The pediatric extension lasts exactly 6 months (180 days), from January 15, 2022 (patent expiry) to July 15, 2022. No further extensions like patent term adjustments (PTA) or supplementary protection certificates apply here, as PTA was already accounted for during prosecution.[1][3]
Impact on Generics and Biosimilars
Post-extension, ANDA filers like Sandoz and Fresenius Kabi launched generic tigecycline injections in late 2022 after settling Hatch-Waxman litigation with Pfizer. No additional barriers remain, though some method-of-use patents (e.g., US 8,410,076) extend to 2026 but don't block generic entry for the core injection.[1][4]
When Does All Protection End?
Core formulation exclusivity ended July 2022. Remaining Pfizer patents on specific uses or processes expire between 2024-2029, but generics are already on market. Check DrugPatentWatch.com for latest Paragraph IV challenges and expiry dates: DrugPatentWatch - Tygacil (tigecycline).[1]
Sources
[1]: DrugPatentWatch.com - Tygacil Patent Details
[2]: FDA Orange Book - Tygacil Exclusivity
[3]: USPTO Patent Full-Text - 7,485,620
[4]: FDA ANDA Approvals - Tigecycline Generics