Generic entry timeline

Alphagan generics — when can they launch?

Alphagan (BRIMONIDINE TARTRATE) · Senju Pharmaceutical Co., Ltd · 18 active US patents · 0 expired

Earliest patent expiry
2029-07-27
3 years remaining
Full patent estate to
2042-11-10
complete protection through 2042
FDA approval
1996
Senju Pharmaceutical Co., Ltd

Where Alphagan sits in the generic timeline

Imminent generic cliff: earliest active US patent for Alphagan expires in 2029 (~3 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.

  • Method of Use — 14 patents
  • Formulation — 4 patents

FDA U-codes carved out by Alphagan 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-2222(no description)
U-3741(no description)
U-1428(no description)

Sample patent estate

Showing 6 of 18 active US patents. View full estate on the Alphagan drug page →

  • US11833245 Method of Use · expires 2029-07-27
    This patent protects compositions, preferably containing brimonidine, for inducing vasoconstriction at low concentrations.
    USPTO title: Vasoconstriction compositions and methods of use
  • US11596600 Method of Use · expires 2029-07-27
    This patent protects compositions, preferably containing brimonidine, for inducing vasoconstriction at low concentrations.
    USPTO title: Vasoconstriction compositions and methods of use
  • US11596600 Method of Use · expires 2029-07-27
    This patent protects compositions, preferably containing brimonidine, for inducing vasoconstriction at low concentrations.
    USPTO title: Vasoconstriction compositions and methods of use
  • US8455494 Method of Use · expires 2030-05-24
    This patent protects a pharmaceutical preparation and method for treating presbyopia using a combination of parasympathomimetic drugs and alpha agonists or antagonists.
    USPTO title: Preparations and methods for ameliorating or reducing presbyopia
  • US9421265 Formulation · expires 2030-06-17
    This patent protects multi-dose ophthalmic compositions containing borate-polyol complexes with antimicrobial activity.
    USPTO title: Aqueous pharmaceutical compositions containing borate-polyol complexes
  • US9259425 Method of Use · expires 2030-07-14
    This patent protects compositions and methods for whitening eyes using low concentrations of selective α-2 adrenergic receptor agonists, preferably including brimonidine.
    USPTO title: Compositions and methods for eye whitening

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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