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]

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]

Has a generic version of CellCept been approved?

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

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: DR REDDYS LABS LTD
    Approval date: October 27, 2011
    Strength(s): 250MG [AB]
  • Manufacturer: MYLAN
    Approval date: May 4, 2009
    Strength(s): 250MG [AB]
  • Manufacturer: ROXANE
    Approval date: July 29, 2008
    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]

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: ROXANE
    Approval date: July 29, 2008
    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]

Note: No generic formulation of the following products are available.

  • mycophenolate mofetil - suspension;oral
  • mycophenolate mofetil hydrochloride - injectable;injection

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: 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.

  • Crystalline anhydrous mycophenolate mofetil and intravenous formulation thereof
    Patent 5,543,408
    Issued: August 6, 1996
    Inventor(s): Fu; Roger C. & Leung; De-Mei & Fleitman; Jeffrey S. & Rizzolio; Michele C. & Miksztal; Andrew R.
    Assignee(s): Syntex (U.S.A.) Inc.
    The crystalline anhydrous salt formed by complexing mycophenolate mofetil with an anion selected from the group chloride, sulfate, phosphate and acetate (in particular the hydrochloride salt), and pharmaceutical compositions, intravenous formulations and a kit thereof, and associated methods of treatment.
    Patent expiration dates:
    • September 15, 2013
      ✓ 
      Drug product
  • Mycophenolate mofetil high dose oral suspensions
    Patent 5,688,529
    Issued: November 18, 1997
    Inventor(s): Lidgate; Deborah Marilyn & Wang-Kessler; Li-hua & Joshi; Bindu & Hegde; Sayee Gojanan & Gu; Leo
    Assignee(s): Syntex (U.S.A) Inc.
    High dose, dry granulations or powder blends and aqueous oral suspensions of mycophenolate mofetil or mycophenolic acid, contain: active compound (7.5-30%), suspending/viscosity agent, sweetener, flavor, buffer (to a pH of 5-7.5), and optionally contain flavor enhancer, wetting agent, antimicrobial agent and color.
    Patent expiration dates:
    • November 18, 2014
      ✓ 
      Drug product

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.
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