Generic entry timeline

Travatan generics — when can they launch?

Travatan (TRAVOPROST) · · 11 active US patents · 0 expired

Earliest patent expiry
2027-09-20
1 year remaining
Full patent estate to
2031-02-14
complete protection through 2031
FDA approval
2001

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-codeDescription
U-4129(no description)

Sample patent estate

Showing 6 of 11 active US patents. View full estate on the Travatan drug page →

  • US8388941 Formulation · expires 2027-09-20
    This patent describes self-preserved aqueous pharmaceutical compositions that do not require a conventional anti-microbial preservative.
    USPTO title: Self preserved aqueous pharmaceutical compositions
  • US8323630 Formulation · expires 2027-09-20
    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
  • US9144561 Formulation · expires 2029-03-13
    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
  • US8754123 Formulation · expires 2029-05-19
    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
  • US8722735 Formulation · expires 2029-10-10
    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
  • US8178582 Formulation · expires 2029-10-10
    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

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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