Generic Plavix Availability

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

PLAVIX (clopidogrel bisulfate - tablet;oral)

Has a generic version of Plavix been approved?

A generic version of Plavix has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Plavix and have been approved by the FDA:

clopidogrel bisulfate tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: March 27, 2013
    Strength(s): EQ 75MG BASE [AB], EQ 300MG BASE [AB]
  • Manufacturer: ACTAVIS TOTOWA
    Approval date: May 28, 2013
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: APOTEX INC
    Approval date: May 17, 2012
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: APOTEX INC
    Approval date: March 4, 2014
    Strength(s): EQ 300MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: May 17, 2012
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: DR REDDYS LABS INC
    Approval date: January 14, 2008
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: May 17, 2012
    Strength(s): EQ 300MG BASE [AB]
  • Manufacturer: GATE PHARMS
    Approval date: May 17, 2012
    Strength(s): EQ 300MG BASE [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: February 10, 2014
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: MUTUAL PHARM
    Approval date: June 10, 2013
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: May 17, 2012
    Strength(s): EQ 75MG BASE [AB], EQ 300MG BASE [AB]
  • Manufacturer: ROXANE
    Approval date: May 17, 2012
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: May 17, 2012
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: TEVA
    Approval date: May 17, 2012
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: May 17, 2012
    Strength(s): EQ 300MG BASE [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: May 17, 2012
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: WOCKHARDT LTD
    Approval date: August 14, 2012
    Strength(s): EQ 75MG BASE [AB]
  • Manufacturer: WOCKHARDT LTD
    Approval date: November 20, 2012
    Strength(s): EQ 300MG BASE [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: October 10, 2012
    Strength(s): EQ 75MG BASE [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Plavix. 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

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.

  • Polymorphic clopidogrel hydrogenesulphate form
    Patent 6,429,210
    Issued: August 6, 2002
    Inventor(s): André ; Bousquet & Bertrand; Castro & Jean; Saint-Germain
    Assignee(s): Sanofi-Synthelabo
    Novel orthorombic polymorph of clopidogrel hydrogen sulfate or hydrogen sulfate of methyl (+)-(S)-&agr;-(2-chlorophenyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-5-acetate and a process for its preparation.
    Patent expiration dates:
    • June 10, 2019
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • December 10, 2019
      ✓ 
      Pediatric exclusivity
  • Polymorphic form of clopidogrel hydrogen sulphate
    Patent 6,504,030
    Issued: January 7, 2003
    Inventor(s): André ; Bousquet & Bertrand; Castro & Jean; Saint-Germain
    Assignee(s): Sanofi-Synthelabo
    Novel orthorombic polymorph of clopidogrel hydrogen sulfate or hydrogen sulfate of methyl (+)-(S)-&agr;-(2-chlorophenyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-5-acetate and a process for its preparation
    Patent expiration dates:
    • June 10, 2019
      ✓ 
      Drug substance
    • December 10, 2019
      ✓ 
      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • May 6, 2014 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • November 6, 2014 -

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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