Valcyte

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

VALCYTE (valganciclovir hydrochloride - for solution; oral)

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

VALCYTE (valganciclovir hydrochloride - tablet; oral)

• 
  Manufacturer: ROCHE PALO
  
  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
    
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    Patent use: TREATMENT OF CMV RETINITIS
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    Drug substance
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    Drug product
  
  
  
  • March 29, 2015
    
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    Patent use: PREVENTION OF CMV DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)
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    Drug substance
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    Drug product
  
  
  
  • September 29, 2015
    
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    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...

• Valcyte Consumer Information (Wolters Kluwer)
• Valcyte Solution Consumer Information (Wolters Kluwer)
• Valcyte Consumer Information (Cerner Multum)
• Valcyte Advanced Consumer Information (Micromedex)
• Valcyte AHFS DI Monographs (ASHP)
• Valganciclovir Consumer Information (Wolters Kluwer)
• Valganciclovir Solution Consumer Information (Wolters Kluwer)
• Valganciclovir Consumer Information (Cerner Multum)
• Valganciclovir Advanced Consumer Information (Micromedex)
• Valganciclovir Hydrochloride AHFS DI Monographs (ASHP)