Generic Valcyte Availability

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

VALCYTE (valganciclovir hydrochloride - for solution; oral)

  • Manufacturer: HOFFMANN LA ROCHE
    Approval date: August 28, 2009
    Strength(s): 50MG/ML [RLD]

VALCYTE (valganciclovir hydrochloride - tablet; oral)

  • Manufacturer: HOFFMANN LA ROCHE
    Approval date: March 29, 2001
    Strength(s): EQ 450MG BASE [RLD]

Has a generic version of Valcyte been approved?

No. There is currently no therapeutically equivalent version of Valcyte available.

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

  • 2- (2-amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3- propanediol derivative
    Patent 6,083,953
    Issued: July 4, 2000
    Inventor(s): Nestor; John Joseph & Womble; Scott William & Maag; Hans
    Assignee(s): Syntex (U.S.A.) Inc.
    The L-monovaline ester derived from 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol and its pharmaceutically acceptable salts are of value as antiviral agents with improved absorption.
    Patent expiration dates:
    • March 29, 2015
      ✓ 
      Patent use: TREATMENT OF CMV RETINITIS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • March 29, 2015
      ✓ 
      Patent use: PREVENTION OF CMV DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 29, 2015
      ✓ 
      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:
    • August 28, 2012 - PREVENTION OF CMV DISEASE IN KIDNEY AND HEART TRANSPLANT PATIENTS 4 MONTHS TO 16 YEARS AT HIGH RISK
    • August 28, 2012 - NEW DOSAGE FORM
    • February 28, 2013 - PEDIATRIC EXCLUSIVITY
    • August 5, 2013 - EXTEND CURRENT DOSING REGIMEN TO 900MG (2-450MG TABLETS) ONCE A DAY WITHIN 10 DAYS OF TRANSPLANTATION UNTIL 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT PATIENTS AT HIGH RISK.

See also...

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.
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