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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] [AB]

VALCYTE (valganciclovir hydrochloride - tablet;oral)

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

Has a generic version of Valcyte been approved?

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

valganciclovir hydrochloride for solution;oral

  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: July 18, 2016
    Strength(s): 50MG/ML [AB]

valganciclovir hydrochloride tablet;oral

  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: March 31, 2016
    Strength(s): EQ 450MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: November 4, 2014
    Strength(s): EQ 450MG BASE [AB]
  • Manufacturer: ENDO PHARMS INC
    Approval date: November 4, 2014
    Strength(s): EQ 450MG BASE [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: March 18, 2016
    Strength(s): EQ 450MG BASE [AB]

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: Generic Drug FAQs.

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.

  • Pharmaceutical dosage forms comprising valganciclovir hydrochloride
    Patent 9,642,911
    Issued: May 9, 2017
    Assignee(s): Hoffmann-La Roche Inc.
    The present invention provides novel solid pharmaceutical dosage forms for oral administration, after being constituted in water. The solid dosage forms comprise a therapeutically effective amount of valganciclovir hydrochloride and a non-hygroscopic organic acid present in an amount sufficient to stabilize the valganciclovir hydrochloride in a predetermined amount of water. The present invention also provides novel liquid pharmaceutical dosage forms for oral administration after constituting the solid pharmaceutical dosage form with water. A non-hygroscopic bulking agent may optionally be included in the above dosage form. These novel pharmaceutical dosage forms are useful in the treatment or control of viruses such as herpes simplex virus and cytomegalovirus. The present invention also provides a method for treating these diseases employing the solid and liquid pharmaceutical dosage forms and a method for preparing these pharmaceutical dosage forms.
    Patent expiration dates:
    • December 11, 2027
      Drug product

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:
    • April 23, 2018 - NEW PATIENT POPULATION
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.