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Generic CellCept Availability

CellCept is a brand name of mycophenolate mofetil, approved by the FDA in the following formulation(s):

CELLCEPT (mycophenolate mofetil - capsule;oral)

  • Manufacturer: ROCHE PALO
    Approval date: May 3, 1995
    Strength(s): 250MG [RLD] [AB]

CELLCEPT (mycophenolate mofetil - suspension;oral)

  • Manufacturer: ROCHE PALO
    Approval date: October 1, 1998
    Strength(s): 200MG/ML [RLD] [AB]

CELLCEPT (mycophenolate mofetil - tablet;oral)

  • Manufacturer: ROCHE PALO
    Approval date: June 19, 1997
    Strength(s): 500MG [RLD] [AB]

CELLCEPT (mycophenolate mofetil hydrochloride - injectable;injection)

  • Manufacturer: ROCHE PALO
    Approval date: August 12, 1998
    Strength(s): 500MG/VIAL [RLD] [AP]

Has a generic version of CellCept been approved?

Yes. The following products are equivalent to CellCept:

mycophenolate mofetil capsule;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: May 4, 2009
    Strength(s): 250MG [AB]
  • Manufacturer: ALKEM LABS LTD
    Approval date: June 13, 2013
    Strength(s): 250MG [AB]
  • Manufacturer: APOTEX CORP
    Approval date: April 22, 2009
    Strength(s): 250MG [AB]
  • Manufacturer: MYLAN
    Approval date: May 4, 2009
    Strength(s): 250MG [AB]
  • Manufacturer: SANDOZ
    Approval date: October 15, 2008
    Strength(s): 250MG [AB]
  • Manufacturer: STRIDES PHARMA
    Approval date: June 10, 2010
    Strength(s): 250MG [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: May 6, 2009
    Strength(s): 250MG [AB]
  • Manufacturer: VINTAGE PHARMS LLC
    Approval date: December 22, 2009
    Strength(s): 250MG [AB]
  • Manufacturer: WEST-WARD PHARMS INT
    Approval date: July 29, 2008
    Strength(s): 250MG [AB]
  • Manufacturer: ZHEJIANG HISUN PHARM
    Approval date: November 13, 2017
    Strength(s): 250MG [AB]

mycophenolate mofetil suspension;oral

  • Manufacturer: ALKEM LABS LTD
    Approval date: November 14, 2014
    Strength(s): 200MG/ML [AB]

mycophenolate mofetil tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: May 4, 2009
    Strength(s): 500MG [AB]
  • Manufacturer: ALKEM LABS LTD
    Approval date: November 4, 2011
    Strength(s): 500MG [AB]
  • Manufacturer: APOTEX
    Approval date: April 22, 2009
    Strength(s): 500MG [AB]
  • Manufacturer: MYLAN
    Approval date: May 4, 2009
    Strength(s): 500MG [AB]
  • Manufacturer: SANDOZ
    Approval date: October 15, 2008
    Strength(s): 500MG [AB]
  • Manufacturer: STRIDES PHARMA
    Approval date: June 10, 2010
    Strength(s): 500MG [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: May 4, 2009
    Strength(s): 500MG [AB]
  • Manufacturer: VINTAGE PHARMS LLC
    Approval date: July 16, 2010
    Strength(s): 500MG [AB]
  • Manufacturer: WEST-WARD PHARMS INT
    Approval date: July 29, 2008
    Strength(s): 500MG [AB]
  • Manufacturer: ZHEJIANG HISUN PHARM
    Approval date: November 16, 2017
    Strength(s): 500MG [AB]

mycophenolate mofetil hydrochloride injectable;injection

  • Manufacturer: AKORN INC
    Approval date: February 28, 2017
    Strength(s): 500MG/VIAL [AP]
  • Manufacturer: MYLAN LABS LTD
    Approval date: March 31, 2017
    Strength(s): 500MG/VIAL [AP]
  • Manufacturer: PAR STERILE PRODUCTS
    Approval date: October 28, 2016
    Strength(s): 500MG/VIAL [AP]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: August 31, 2017
    Strength(s): 500MG/VIAL [AP]

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

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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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.

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