Generic entry timeline

Angiomax generics — when can they launch?

Angiomax (BIVALIRUDIN) · Novartis · 8 active US patents · 0 expired

Earliest patent expiry
2028-07-27
2 years remaining
Full patent estate to
2039-05-20
complete protection through 2039
FDA approval
2000
Novartis

Where Angiomax sits in the generic timeline

Imminent generic cliff: earliest active US patent for Angiomax 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.

  • Formulation — 3 patents
  • Method of Use — 3 patents
  • Other — 2 patents

FDA U-codes carved out by Angiomax 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-3817(no description)

Sample patent estate

Showing 6 of 8 active US patents. View full estate on the Angiomax drug page →

  • US7598343 Formulation · expires 2028-07-27
    This patent protects pharmaceutical formulations of bivalirudin, including Angiomax, and methods for preparing them.
    USPTO title: Pharmaceutical formulations of bivalirudin and processes of making the same
  • US7582727 Formulation · expires 2028-07-27
    This patent protects pharmaceutical formulations of bivalirudin, including a specific method of preparing them, with certain quality control standards.
    USPTO title: Pharmaceutical formulations of bivalirudin and processes of making the same
  • US7582727 Other · expires 2029-01-27
    This patent protects pharmaceutical formulations of bivalirudin, including methods for making them, with specific impurity and reconstitution time requirements.
    USPTO title: Pharmaceutical formulations of bivalirudin and processes of making the same
  • US7598343 Other · expires 2029-01-27
    This patent protects pharmaceutical formulations of bivalirudin, including methods for making them, with specific impurity and reconstitution time requirements.
    USPTO title: Pharmaceutical formulations of bivalirudin and processes of making the same
  • US11903993 Method of Use · expires 2039-05-20
    This patent protects ready-to-use liquid bivalirudin compositions and methods for using and preparing them.
    USPTO title: Ready-to-use bivalirudin compositions
  • US12472224 Method of Use · expires 2039-05-20
    This patent protects ready-to-use liquid bivalirudin compositions and methods for using and preparing them.
    USPTO title: Ready-to-use bivalirudin compositions

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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