Core Patent Expiry for Tigecycline Injection
Tigecycline injection (brand name Tygacil), developed by Wyeth (now Pfizer), has its primary U.S. composition-of-matter patent (U.S. Patent No. 5,998,369) expiring on November 23, 2023.[1] This covers the active ingredient and basic formulation for intravenous use.
Pediatric Exclusivity Extension
The patent term was extended by 6 months via pediatric exclusivity under the FDA's Best Pharmaceuticals for Children Act (BPCA). This adds exclusivity until May 23, 2024, delaying generic entry even if patents expire earlier. Pediatric studies supported label expansions for pediatric sepsis and complicated intra-abdominal infections.[1][2]
Additional Formulation and Method Patents
- Method-of-use patents (e.g., U.S. Patent No. 7,858,661 for specific infections) extend to March 31, 2027, with potential pediatric extension to September 30, 2027.[1]
- A crystalline formulation patent (U.S. Patent No. 8,410,154) lasts until April 24, 2028, potentially blocking certain generics.[1]
When Do Generics Enter the Market?
No generics are approved yet due to ongoing patent challenges and 30-month FDA stays from Pfizer's litigation against Sandoz and others. First generic approvals are possible post-May 2024 for basic formulations, but Paragraph IV suits could delay until 2027-2028. Check DrugPatentWatch.com for live Paragraph IV updates and exact expiry timelines.[1]
Why the Extensions Matter for Pricing and Access
Pediatric exclusivity keeps Tygacil prices high (~$2,000 per course) despite patent expiry, as it blocks ANDA approvals. Biosimilar-like generics face formulation hurdles, unlike small-molecule antibiotics.[1][3]
Sources:
[1]: DrugPatentWatch.com - Tygacil Patents
[2]: FDA Orange Book - Tygacil Exclusivities
[3]: FDA Paragraph IV Litigation Tracker