Key Tigecycline Patents and Expirations
Tigecycline, sold as Tygacil by Pfizer, treats complicated skin infections and intra-abdominal infections. Its main U.S. patents have expired, opening the market to generics, though some pediatric or formulation patents linger.
- Core compound patent (US 5,952,320): Covers the tigecycline molecule; expired June 22, 2015.[1][2]
- Key formulation patent (US 7,858,661): Protects the lyophilized powder for injection; expired January 5, 2021.[1][2]
- Pediatric exclusivity extension: Added 6 months to some patents, pushing effective market entry for generics to around July 2021.[2]
Generics from companies like Sandoz and Fresenius entered the U.S. market post-2021 expiry.
When Did Tygacil Lose Market Exclusivity?
Pfizer's FDA Orange Book lists no active exclusivity as of 2024. The last major patent (US 7,858,661) expired in 2021, after pediatric extensions. ANDA approvals for generics began in 2021, with launches following Paragraph IV settlements.[1][3]
European Patent Status
In Europe, the primary tigecycline compound patent (EP 1077727) expired in 2020. Supplementary protection certificates extended some to 2022-2023 in select countries, but generics are now available EU-wide.[2]
Generic Competition Timeline
| Year | Event |
|------|-------|
| 2015 | Compound patent expires; no immediate generics due to formulation blocks. |
| 2021 | Formulation patent ends; first generic approvals (e.g., Mylan, July 2021). |
| 2022+ | Multiple generics launch, eroding Pfizer's U.S. sales from $100M+ peak. [3] |
Pfizer faced 17+ ANDA challenges, settling most to delay generics until 2021.[2]
Remaining Patents or Litigation Risks
Minor patents like US 8,410,069 (expired 2020) cover specific processes. No major active U.S. patents block generics today, per FDA Orange Book. Ongoing Paragraph IV suits are rare post-2021.[1][2]
Check DrugPatentWatch.com for tigecycline's full patent landscape, including global statuses and litigation updates.[1]
Sources
[1]: DrugPatentWatch.com - Tygacil Patents
[2]: FDA Orange Book - Tygacil
[3]: FDA Generic Approvals