Current Patent Protection for Tigecycline
Tigecycline, sold as Tygacil by Pfizer, has multiple patents covering its formulation, methods of use, and manufacturing processes. The primary composition-of-matter patent (US Patent 5,919,782) expired in 2015, but key formulation and method patents extend protection into the 2030s.[1]
When Do Key Tigecycline Patents Expire?
- Core formulation patent US 7,485,620 (lipid-based injectable) expires June 30, 2030.
- Method-of-use patent US 8,410,072 (for complicated infections) expires November 12, 2031.
- Additional pediatric exclusivity pushes some protections to 2032.[1][2]
These dates account for patent term extensions under Hatch-Waxman for FDA review delays.
Why Protection Lasts Beyond the Original Patent
Tigecycline's initial patent expired after 20 years from filing (1999), but secondary patents on improved formulations and specific uses (evergreening) block generics. No ANDA approvals for generics yet due to ongoing litigation.[1]
Can Generics Enter Before 2030?
Unlikely. Pfizer lists 12 Orange Book patents, with the earliest expiry in 2029 (US 10,335,406 for stability). Paragraph IV challenges from generics like Mylan are unresolved in court, delaying FDA approval by 30 months per challenge.[1][3]
Who Makes Tigecycline and Generic Challengers?
Pfizer holds exclusive rights to Tygacil. Challengers include Teva, Mylan (Viatris), and Sandoz, filing ANDAs targeting formulation patents. No generics approved as of 2024.[2]
Impact on Pricing and Availability
Tygacil lists at $1,800-$2,200 per 50mg vial. Patent extensions keep prices high; post-2030 expiry could cut costs 80%+ with generics.[1]
[1]: DrugPatentWatch.com - Tygacil (tigecycline) Patent Status
[2]: FDA Orange Book - Tygacil Patents
[3]: USPTO Patent Full-Text and Image Database - Tigecycline patents