Valtrex

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: ACTAVIS PHARMA
  
  Approval date: March 16, 2011
  
  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: DR REDDYS LABS LTD
  
  Approval date: May 24, 2010
  
  Strength(s): EQ 1GM BASE ^[AB], EQ 500MG BASE ^[AB]


• 
  Manufacturer: MATRIX LABS LTD
  
  Approval date: May 24, 2010
  
  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: 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
  
  Approval date: May 24, 2010
  
  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 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
  
  
  
  • January 19, 2016
    
    ✓ 
    Patent use: TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
    ✓ 
    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 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
  
  
  
  • January 19, 2016
    
    ✓ 
    Patent use: TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
    ✓ 
    Drug substance
  
  
  
  • July 19, 2016
    
    ✓ 
    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:
  • September 2, 2011 - NEW PATIENT POPULATION
  
  
  • September 2, 2011 - TREATMENT OF CHICKEN POX IN IMMUNOCOMPETENT PEDIATRIC PATIENTS 2 TO
    
  • March 2, 2012 - PEDIATRIC EXCLUSIVITY
  
  

See also...

• Valtrex Consumer Information (Drugs.com)
• Valtrex Consumer Information (Wolters Kluwer)
• Valtrex Consumer Information (Cerner Multum)
• Valtrex Advanced Consumer Information (Micromedex)
• Valtrex AHFS DI Monographs (ASHP)
• Valacyclovir Consumer Information (Drugs.com)
• Valacyclovir Consumer Information (Wolters Kluwer)
• Valacyclovir Consumer Information (Cerner Multum)
• Valacyclovir Advanced Consumer Information (Micromedex)
• Valacyclovir Hydrochloride AHFS DI Monographs (ASHP)