Generic entry timeline

Cytarabine generics — when can they launch?

Cytarabine (Cytarabine) · Nippon Shinyaku Co., Ltd. · 15 active US patents · 0 expired

Earliest patent expiry
2026-06-07
expired
Full patent estate to
2033-04-15
complete protection through 2033
FDA approval
1969
Nippon Shinyaku Co., Ltd.

Where Cytarabine sits in the generic timeline

All listed Orange Book patents for Cytarabine have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.

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.

  • Other — 7 patents
  • Method of Use — 6 patents
  • Formulation — 2 patents

FDA U-codes carved out by Cytarabine 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-3147(no description)
U-3150(no description)
U-3149(no description)

Sample patent estate

Showing 6 of 15 active US patents. View full estate on the Cytarabine drug page →

  • US8518437 Formulation · expires 2026-06-07
    This patent protects lipid carrier compositions, specifically liposomes, that contain at least 10 mol % of a negatively charged lipid coupled to a non-zwitterionic moiety.
    USPTO title: Lipid carrier compositions with enhanced blood stability
  • US7850990 Method of Use · expires 2027-01-23
    This patent protects compositions that deliver non-antagonistic combinations of two or more agents, such as antineoplastic agents, like Cytarabine.
    USPTO title: Compositions for delivery of drug combinations
  • US9271931 Formulation · expires 2027-01-23
    This patent protects compositions that deliver non-antagonistic combinations of two or more agents, such as antineoplastic agents, in a stable form.
    USPTO title: Compositions for delivery of drug combinations
  • US7850990 Other · expires 2027-07-23
    This patent protects compositions that deliver non-antagonistic combinations of two or more agents, such as antineoplastic agents, together.
    USPTO title: Compositions for delivery of drug combinations
  • US9271931 Other · expires 2027-07-23
    This patent protects compositions that deliver non-antagonistic combinations of two or more agents, such as antineoplastic agents, together.
    USPTO title: Compositions for delivery of drug combinations
  • US8022279 Method of Use · expires 2027-09-14
    This patent protects liposomal formulations that combine an anthracycline agent with a cytidine analog, such as cytarabine, for sustained drug release.
    USPTO title: Liposomal formulations of anthracycline agents and cytidine analogs

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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