Generic entry timeline

Tryptyr generics — when can they launch?

Tryptyr (ACOLTREMON) · Alcon Labs Inc · 5 active US patents · 0 expired

Earliest patent expiry
2031-09-08
5 years remaining
Full patent estate to
2042-12-16
complete protection through 2042
FDA approval
2025
Alcon Labs Inc

Where Tryptyr sits in the generic timeline

Mid-term cliff: earliest active US patent for Tryptyr expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.

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.

  • Method of Use — 5 patents

FDA U-codes carved out by Tryptyr 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-1900(no description)

Sample patent estate

Showing 5 of 5 active US patents. View full estate on the Tryptyr drug page →

  • US10028920 Method of Use · expires 2031-09-08
    This patent protects methods for treating ocular irritation involving tearing by administering modulators of the TRPM8 receptor.
    USPTO title: Methods for treating occular irritation involving tearing by administering modulators of TRPM8
  • US9433679 Method of Use · expires 2031-09-08
    This patent protects the use of TRMP8 receptor agonist and antagonist ligands for treating dry eye and epiphora.
    USPTO title: Use of TRMP8 for treating opthalmic diseases or conditions involving tearing
  • US9095609 Method of Use · expires 2031-09-08
    This patent protects ophthalmic compositions containing WS-12 and methods for treating dry eye and epiphora.
    USPTO title: Ophthalmic composition comprising ws-12 and methods to treat xerophthalmia
  • US11850221 Method of Use · expires 2042-12-16
    This patent protects ophthalmic pharmaceutical compositions containing WS-12 for treating, preventing, or ameliorating dry eye in a subject.
    USPTO title: Ophthalmic pharmaceutical compositions and uses thereof
  • US12336971 Method of Use · expires 2042-12-16
    This patent protects ophthalmic pharmaceutical compositions containing WS-12 for treating, preventing, or ameliorating dry eye in a subject.
    USPTO title: Ophthalmic pharmaceutical compositions and uses thereof

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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