Generic Gemzar Availability

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

GEMZAR (gemcitabine hydrochloride - injectable;injection)

  • Manufacturer: LILLY
    Approval date: May 15, 1996
    Strength(s): EQ 1GM BASE/VIAL [RLD] [AP], EQ 200MG BASE/VIAL [RLD] [AP]

Has a generic version of Gemzar been approved?

Yes. The following products are equivalent to Gemzar:

gemcitabine hydrochloride injectable;injection

  • Manufacturer: ACCORD HLTHCARE
    Approval date: July 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: July 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: CIPLA LTD
    Approval date: July 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: July 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: EMCURE PHARMS LTD
    Approval date: September 11, 2012
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: FRESENIUS KABI ONCOL
    Approval date: July 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: HAMELN RDS GMBH
    Approval date: September 10, 2012
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: HOSPIRA
    Approval date: July 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: JIANGSU HANSOH PHARM
    Approval date: May 7, 2013
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: LUITPOLD
    Approval date: May 7, 2013
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: ONCO THERAPIES LTD
    Approval date: July 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: SAGENT PHARMS
    Approval date: May 7, 2013
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: July 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]
  • Manufacturer: TEVA PHARMS
    Approval date: January 25, 2011
    Strength(s): EQ 1GM BASE/VIAL [AP], EQ 200MG BASE/VIAL [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gemzar. 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: About generic drugs.

Related Patents

There are no current U.S. patents associated with Gemzar.

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.
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