Generic entry timeline

Tygacil generics — when can they launch?

Tygacil (TIGECYCLINE) · Fresenius Kabi · 4 active US patents · 3 expired

Earliest patent expiry

2028-10-24

2 years remaining

Full patent estate to

2033-04-07

complete protection through 2033

FDA approval

2005

Fresenius Kabi

Where Tygacil sits in the generic timeline

Imminent generic cliff: earliest active US patent for Tygacil expires in 2028 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

Formulation — 4 patents

Sample patent estate

Showing 4 of 4 active US patents. View full estate on the Tygacil drug page →

US8975242 Formulation · expires 2028-10-24

This patent protects novel tigecycline compositions with improved stability in both solid and solution states and processes for making these compositions.

USPTO title: Tigecycline compositions and methods of preparation
US7879828 Formulation · expires 2029-02-05

This patent protects novel tigecycline compositions with improved stability, comprising tigecycline, a carbohydrate, and an acid or buffer.

USPTO title: Tigecycline compositions and methods of preparation
US8372995 Formulation · expires 2030-10-08

This patent protects crystalline solid forms of tigecycline, specifically Forms I, II, III, IV, and V, and methods for preparing them.

USPTO title: Crystalline solid forms of tigecycline and methods of preparing same
US9855335 Formulation · expires 2033-04-07

This patent protects a tigecycline composition for injection that includes a propping agent and a stabilization agent.

USPTO title: Tigecycline composition for injection

Sources

FDA Orange Book — patents listed against Tygacil (NDA filed 2005)
Tygacil drug profile — full patent estate, indications, clinical trials, pricing
Fresenius Kabi patent portfolio
Patent cliff 2028 — every drug losing US exclusivity that year

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

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