Generic Epivir Availability

See also: Generic Epivir-HBV

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

EPIVIR (lamivudine - solution;oral)

  • Manufacturer: VIIV HLTHCARE
    Approval date: November 17, 1995
    Strength(s): 10MG/ML [RLD]

EPIVIR (lamivudine - tablet;oral)

  • Manufacturer: VIIV HLTHCARE
    Approval date: November 17, 1995
    Strength(s): 150MG [AB]
  • Manufacturer: VIIV HLTHCARE
    Approval date: June 24, 2002
    Strength(s): 300MG [RLD] [AB]

Has a generic version of Epivir been approved?

A generic version of Epivir 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 Epivir and have been approved by the FDA:

lamivudine tablet;oral

  • Manufacturer: APOTEX
    Approval date: December 2, 2011
    Strength(s): 150MG [AB], 300MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: November 17, 2011
    Strength(s): 150MG [AB], 300MG [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: January 6, 2014
    Strength(s): 150MG [AB], 300MG [AB]

Note: No generic formulation of the following product is available.

  • lamivudine - solution;oral

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

  • Crystalline oxathiolane derivatives
    Patent 5,905,082
    Issued: May 18, 1999
    Inventor(s): Roberts; Tony Gordon & Evans; Paul
    Assignee(s): Glaxo Group Limited
    (-)cis-4-Amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(IH)-pyrimidine-2-on e in crystalline form, in particular as needle-shaped or bypyramidyl crystals, pharmaceutical formulations thereof, methods for their preparation and their use in medicine.
    Patent expiration dates:
    • May 18, 2016
    • May 18, 2016
      ✓ 
      Patent use: TREATMENT OF HIV
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • November 18, 2016
      ✓ 
      Pediatric exclusivity
  • Pharmaceutical compositions containing lamivudine
    Patent 6,004,968
    Issued: December 21, 1999
    Inventor(s): Casey; Warren Michael & Nguyen; Ngoc-Anh Thi
    Assignee(s): Glaxo Wellcome Inc.
    The present invention relates to pharmaceutical formulations containing (2R, cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2 -one (-)-2',3'-dideoxy,3'-thiacytidine, lamivudine, that are substantially free of ethanol and ethylenediamine-tetraacitic acid, and their use in medical therapy.
    Patent expiration dates:
    • March 20, 2018
    • September 20, 2018
      ✓ 
      Pediatric exclusivity

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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