Travatan generics — when can they launch?
Travatan (TRAVOPROST) · · 11 active US patents · 0 expired
Where Travatan sits in the generic timeline
Imminent generic cliff: earliest active US patent for Travatan expires in 2027 (~1 year 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 — 9 patents
- Method of Use — 1 patent
- Composition of Matter — 1 patent
FDA U-codes carved out by Travatan patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-4129 | (no description) |
Sample patent estate
Showing 6 of 11 active US patents. View full estate on the Travatan drug page →
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This patent describes self-preserved aqueous pharmaceutical compositions that do not require a conventional anti-microbial preservative.USPTO title: Self preserved aqueous pharmaceutical compositions
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This patent protects self-preserved ophthalmic compositions that can be used in multi-dose applications without the need for conventional antimicrobial preservatives.USPTO title: Self-preserved aqueous pharmaceutical compositions
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This patent protects pharmaceutical compositions, particularly ophthalmic compositions, that include a therapeutic agent and a low amount of surfactant for improved bioavailability.USPTO title: Pharmaceutical compositions having desirable bioavailability
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This patent protects pharmaceutical compositions, specifically ophthalmic compositions, that include a therapeutic agent like travoprost and a low amount of surfactant like castor oil.USPTO title: Pharmaceutical compositions having desirable bioavailability
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This patent protects pharmaceutical compositions, specifically ophthalmic compositions, that include a therapeutic agent like travoprost and a low amount of surfactant like castor oil.USPTO title: Pharmaceutical compositions having desirable bioavailability
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This patent protects pharmaceutical compositions, particularly ophthalmic compositions, that include a therapeutic agent and a low amount of surfactant for improved bioavailability.USPTO title: Pharmaceutical compositions having desirable bioavailability
Sources
- FDA Orange Book — patents listed against Travatan (NDA filed 2001)
- Travatan drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — 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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