Generic entry timeline

Gemzar generics — when can they launch?

Gemzar (Gemcitabine Hydrochloride) · Accord Hlthcare · 15 active US patents · 0 expired

Earliest patent expiry
2030-06-28
4 years remaining
Full patent estate to
2034-08-19
complete protection through 2034
FDA approval
1996
Accord Hlthcare

Where Gemzar sits in the generic timeline

Mid-term cliff: earliest active US patent for Gemzar expires in 2030 (~4 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.

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 — 15 patents

Sample patent estate

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

  • US12403086 Formulation · expires 2030-06-28
    This patent protects a solid tablet drug dosage form for implantable drug delivery devices, primarily containing a local anesthetic agent.
    USPTO title: Solid drug tablets for implantable drug delivery devices
  • US12576253 Formulation · expires 2030-12-17
    This patent protects a drug delivery device that can be fully deployed within a patient's bladder and is designed to be well-tolerated.
    USPTO title: Drug delivery device with intravesical tolerability
  • US8679094 Formulation · expires 2032-04-15
    This patent protects an implantable device that can be deployed within a patient's bladder for treatment, with a design intended to be well-tolerated and prevent it from entering the ureters.
    USPTO title: Implantable device with intravesical tolerability and methods of treatment
  • US9241948 Formulation · expires 2033-07-01
    This patent protects a large volume infusion dosage form of gemcitabine, a stable solution ready to be infused.
    USPTO title: Ready to be infused gemcetabine solution
  • US9241948 Formulation · expires 2033-07-01
    This patent protects a large volume infusion dosage form of gemcitabine, a stable solution ready to be infused.
    USPTO title: Ready to be infused gemcetabine solution
  • US9241948 Formulation · expires 2033-07-01
    This patent protects a large volume infusion dosage form of gemcitabine, a stable solution ready to be infused.
    USPTO title: Ready to be infused gemcetabine solution

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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