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Generic Infugem Availability

Last updated on Sep 8, 2022.

Infugem is a brand name of gemcitabine, approved by the FDA in the following formulation(s):

INFUGEM (gemcitabine hydrochloride - solution;intravenous)

  • Manufacturer: SUN PHARM
    Approval date: July 16, 2018
    Strength(s): EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) [RLD], EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) [RLD], EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) [RLD], EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) [RLD], EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) [RLD], EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) [RLD], EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) [RLD], EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) [RLD], EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) [RLD], EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) [RLD]

Has a generic version of Infugem been approved?

No. There is currently no therapeutically equivalent version of Infugem available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Infugem. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Ready to be infused gemcetabine solution
    Patent 9,241,948
    Issued: January 26, 2016
    Assignee(s): Sun Pharmaceutical Industries Ltd.

    A large volume infusion dosage form of gemcitabine, comprising a stable large volume solution of gemcitabine or its pharmaceutically acceptable salt in an aqueous vehicle filled in a large volume infusion container, wherein the solution is ready-to-be-infused.

    Patent expiration dates:

    • July 1, 2033
      Drug product


Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.