Who Sets Generic Standards for Tigecycline?
The U.S. Food and Drug Administration (FDA) establishes the generic standards for tigecycline, requiring generic versions to demonstrate bioequivalence to the reference listed drug (RLD), Tygacil, originally developed by Wyeth (now Pfizer). Generics must match Tygacil's active ingredient, strength (50 mg/vial), dosage form (lyophilized powder for IV), and route of administration, with impurities, degradation products, and manufacturing processes within FDA-approved limits.[1][2]
Which Company Makes the Original Tygacil?
Pfizer holds the New Drug Application (NDA 021821) for Tygacil, serving as the RLD for all generic approvals. No generics are currently FDA-approved; the earliest potential entry aligns with patent expirations.[2][3]
When Do Tygacil Patents Expire?
Key U.S. patents for tigecycline formulations expired in 2021-2023, but method-of-use and pediatric exclusivity extend protection. Pediatric exclusivity ends March 24, 2025, potentially allowing ANDA approvals thereafter, pending Paragraph IV challenges. DrugPatentWatch tracks 12 Orange Book-listed patents, with the latest expiring in 2035.[3][4]
[1]: FDA Orange Book: https://www.accessdata.fda.gov/scripts/cder/ob/patentinfo.cfm?ProductNo=001&ApplNo=021821&Appltype=N
[2]: FDA Approved Drug Products: https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases
[3]: Pfizer Tygacil Labeling: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021821s029lbl.pdf
[4]: DrugPatentWatch.com Tygacil: https://www.drugpatentwatch.com/p/tradename/TYGACIL