Wednesday, 23 December 2009

CellCept


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 INC

    Approval date: May 4, 2009

    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: ENDO PHARMS

    Approval date: December 22, 2009

    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 ARCOLAB LTD

    Approval date: June 10, 2010

    Strength(s): 250MG [AB]


  • Manufacturer: TEVA PHARMS

    Approval date: May 6, 2009

    Strength(s): 250MG [AB]


  • Manufacturer: ZYDUS PHARMS USA INC

    Approval date: May 4, 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: ENDO PHARMS

    Approval date: July 16, 2010

    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 ARCOLAB LTD

    Approval date: June 10, 2010

    Strength(s): 500MG [AB]


  • Manufacturer: TEVA PHARMS

    Approval date: May 4, 2009

    Strength(s): 500MG [AB]


  • Manufacturer: ZYDUS PHARMS USA INC

    Approval date: May 4, 2009

    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



See also...

  • Cellcept Consumer Information (Drugs.com)
  • CellCept Consumer Information (Wolters Kluwer)
  • CellCept Capsules Consumer Information (Wolters Kluwer)
  • CellCept Solution Consumer Information (Wolters Kluwer)
  • CellCept Suspension Consumer Information (Wolters Kluwer)
  • CellCept Consumer Information (Cerner Multum)
  • Cellcept Advanced Consumer Information (Micromedex)
  • Cellcept Oral Advanced Consumer Information (Micromedex)
  • Mycophenolate Mofetil Consumer Information (Wolters Kluwer)
  • Mycophenolate Mofetil Capsules Consumer Information (Wolters Kluwer)
  • Mycophenolate Mofetil Solution Consumer Information (Wolters Kluwer)
  • Mycophenolate Mofetil Suspension Consumer Information (Wolters Kluwer)
  • Mycophenolate mofetil Consumer Information (Cerner Multum)
  • Mycophenolate Intravenous Advanced Consumer Information (Micromedex)
  • Mycophenolate mofetil Advanced Consumer Information (Micromedex)
  • Mycophenolate mofetil Oral, Intravenous Advanced Consumer Information (Micromedex)
  • Mycophenolate AHFS DI Monographs (ASHP)

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