Medication Guide App

Generic Myfortic Availability

Myfortic is a brand name of mycophenolic acid, approved by the FDA in the following formulation(s):

MYFORTIC (mycophenolic acid - tablet, delayed release;oral)

  • Manufacturer: NOVARTIS
    Approval date: February 27, 2004
    Strength(s): 180MG [AB], 360MG [RLD] [AB]

Has a generic version of Myfortic been approved?

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

mycophenolic acid tablet, delayed release;oral

  • Manufacturer: APOTEX INC
    Approval date: August 21, 2012
    Strength(s): 180MG [AB]
  • Manufacturer: APOTEX INC
    Approval date: August 19, 2014
    Strength(s): 360MG [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: January 8, 2014
    Strength(s): 180MG [AB], 360MG [AB]

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

  • Enteric-coated pharmaceutical compositions of mycophenolate
    Patent 6,025,391
    Issued: February 15, 2000
    Inventor(s): Haeberlin; Barbara & Mak; Ching-Pong & Meinzer; Armin & Vonderscher; Jacky
    Assignee(s): Novartis AG
    Disclosed are pharmaceutical compositions which have been modified to release pharmaceutically acceptable mycophenolate salts in the upper part of the intestinal tract and methods of treatment using the pharmaceutical compositions.
    Patent expiration dates:
    • April 10, 2017
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING ALLOGENEIC RENAL TRANSPLANTS
      ✓ 
      Drug product
  • Entric-coated pharmaceutical compositions
    Patent 6,172,107
    Issued: January 9, 2001
    Inventor(s): Haeberlin; Barbara & Mak; Ching-Pong & Meinzer; Armin & Vonderscher; Jacky
    Assignee(s): Novartis AG
    This invention provides a pharmaceutical composition comprising a mycophenolate salt, the composition being adapted to release mycophenolate in the upper part of the intestinal tract.
    Patent expiration dates:
    • April 10, 2017
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING ALLOGENEIC RENAL TRANSPLANTS
      ✓ 
      Drug product
  • Enteric coated pharmaceutical compositions
    Patent 6,306,900
    Issued: October 23, 2001
    Inventor(s): Haeberlin; Barbara & Mak; Ching-Pong & Meinzer; Armin & Vonderscher; Jacky
    Assignee(s): Novartis AG
    This invention provides a pharmaceutical composition comprising a mycophenolate salt, the composition being adapted to release mycophenolate in the upper part of the intestinal tract.
    Patent expiration dates:
    • February 27, 2018
      ✓ 
      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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