Generic Valtrex Availability

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

VALTREX (valacyclovir hydrochloride - tablet;oral)

  • Manufacturer: GLAXOSMITHKLINE
    Approval date: June 23, 1995
    Strength(s): EQ 1GM BASE [RLD] [AB], EQ 500MG BASE [AB]

Has a generic version of Valtrex been approved?

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

valacyclovir hydrochloride tablet;oral

  • Manufacturer: APOTEX INC
    Approval date: April 4, 2014
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: CIPLA LTD
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: JUBILANT GENERICS
    Approval date: April 3, 2012
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: RANBAXY
    Approval date: January 31, 2007
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: ROXANE
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: SANDOZ
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: WATSON LABS INC
    Approval date: March 16, 2011
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]
  • Manufacturer: WOCKHARDT
    Approval date: May 24, 2010
    Strength(s): EQ 1GM BASE [AB], EQ 500MG BASE [AB]

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

  • Valaciclovir tablets containing colloidal silicon dioxide
    Patent 5,879,706
    Issued: March 9, 1999
    Inventor(s): Carter; Barry Howard & Tillman; Lloyd Gary
    Assignee(s): Glaxo Wellcome Inc.
    A tablet comprising at least 50% w/w valaciclovir and 0.05 to 3% w/w colloidal silicon dioxide in which the valaciclovir is present within granules of the tablets and the silicon dioxide, a lubricant and a microcrystalline cellulose filler are present extragranularly has excellent hardness and friability properties while still maintaining lubrication of the tablet granules.
    Patent expiration dates:
    • January 19, 2016
      ✓ 
      Patent use: TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • January 19, 2016
      ✓ 
      Patent use: TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES, SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS, REDUCTION OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES
      ✓ 
      Drug product
    • July 19, 2016
      ✓ 
      Pediatric exclusivity
  • Guanine derivative
    Patent 6,107,302
    Issued: August 22, 2000
    Inventor(s): Carter; Barry Howard & Partin; Jane Muse & Varlashkin; Peter Gregory & Winnike; Richard Augustus & Grubb, III; William Bayne & Conway; Gregory Alan & Lake; Philip George & Skinner; David Michael & Whatrup; David James
    Assignee(s): Glaxo Wellcome Inc.
    The invention relates to an anhydrous crystalline form of (2-[2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy]ethyl L-valinate hydrochloride (otherwise known as valaciclovir hydrochloride) and a process for preparing it.
    Patent expiration dates:
    • January 19, 2016
      ✓ 
      Patent use: TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
      ✓ 
      Drug substance
    • January 19, 2016
      ✓ 
      Patent use: TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES, SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS, REDUCTION OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES
      ✓ 
      Drug substance
    • July 19, 2016
      ✓ 
      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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