Generic entry timeline

Brenzavvy generics — when can they launch?

Brenzavvy (BEXAGLIFLOZIN) · Theracosbio · 6 active US patents · 0 expired

Earliest patent expiry
2028-08-22
2 years remaining
Full patent estate to
2032-05-14
complete protection through 2032
FDA approval
2023
Theracosbio

Where Brenzavvy sits in the generic timeline

Imminent generic cliff: earliest active US patent for Brenzavvy 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.

  • Method of Use — 4 patents
  • Composition of Matter — 2 patents

FDA U-codes carved out by Brenzavvy 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-2214(no description)

Sample patent estate

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

  • US8802637 Method of Use · expires 2028-08-22
    This patent protects benzylbenzene derivatives, including Brenzavvy, for treating diseases and conditions affected by sodium-dependent glucose cotransporter SGLT inhibition.
    USPTO title: Benzylbenzene derivatives and methods of use
  • US8106021 Method of Use · expires 2028-08-22
    This patent protects compounds that inhibit sodium-dependent glucose cotransporter SGLT and methods of using them to treat diseases and conditions affected by SGLT inhibition.
    USPTO title: Benzylbenzene derivatives and methods of use
  • US7838499 Method of Use · expires 2029-01-30
    This patent protects benzylbenzene derivatives, including Brenzavvy, for use in treating diseases and conditions affected by sodium-dependent glucose cotransporter SGLT inhibition.
    USPTO title: Benzylbenzene derivatives and methods of use
  • US10981942 Composition of Matter · expires 2031-06-13
    This patent protects crystalline forms of a compound that inhibits sodium-dependent glucose cotransporter SGLT2.
    USPTO title: Crystalline form of benzylbenzene SGLT2 inhibitor
  • US10533032 Method of Use · expires 2031-07-03
    This patent protects crystalline forms of a compound that inhibits sodium-dependent glucose cotransporter SGLT2, and methods of using it to treat diseases affected by SGLT or SGLT2 inhibition.
    USPTO title: Crystalline form of benzylbenzene SGLT2 inhibitor
  • US8987323 Composition of Matter · expires 2032-05-14
    This patent protects crystalline forms of a compound that inhibits sodium-dependent glucose cotransporter SGLT2.
    USPTO title: Crystalline form of benzylbenzene SGLT2 inhibitor

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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