Generic entry timeline

Vidaza generics — when can they launch?

Vidaza (azacitidine) · Bristol-Myers Squibb · 6 active US patents · 0 expired

Earliest patent expiry
2029-05-14
3 years remaining
Full patent estate to
2030-06-03
complete protection through 2030
FDA approval
2004
Bristol-Myers Squibb

Where Vidaza sits in the generic timeline

Imminent generic cliff: earliest active US patent for Vidaza 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 — 4 patents
  • Formulation — 2 patents

FDA U-codes carved out by Vidaza 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-2950(no description)

Sample patent estate

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

  • US12053482 Method of Use · expires 2029-05-14
    This patent protects pharmaceutical compositions of cytidine analogs for oral administration that release the active ingredient in the stomach.
    USPTO title: Oral formulations of cytidine analogs and methods of use thereof
  • US11571436 Formulation · expires 2029-05-14
    This patent protects oral formulations of cytidine analogs that release the active ingredient substantially in the stomach.
    USPTO title: Oral formulations of cytidine analogs and methods of use thereof
  • US12053482 Method of Use · expires 2029-05-14
    This patent protects pharmaceutical compositions of cytidine analogs for oral administration that release the active ingredient in the stomach.
    USPTO title: Oral formulations of cytidine analogs and methods of use thereof
  • US11571436 Formulation · expires 2029-05-14
    This patent protects oral formulations of cytidine analogs that release the active ingredient substantially in the stomach.
    USPTO title: Oral formulations of cytidine analogs and methods of use thereof
  • US8846628 Method of Use · expires 2030-06-03
    This patent protects oral formulations of cytidine analogs, such as 5-azacytidine or decitabine, for treating diseases and disorders.
    USPTO title: Oral formulations of cytidine analogs and methods of use thereof
  • US8846628 Method of Use · expires 2030-06-03
    This patent protects oral formulations of cytidine analogs, such as 5-azacytidine or decitabine, for use in treating diseases and disorders.
    USPTO title: Oral formulations of cytidine analogs and methods of use 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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