Generic Fortamet Availability

Fortamet is a brand name of metformin, approved by the FDA in the following formulation(s):

FORTAMET (metformin hydrochloride - tablet, extended release;oral)

  • Manufacturer: ANDRX LABS LLC
    Approval date: April 27, 2004
    Strength(s): 1GM [RLD] [AB2], 500MG [AB2]

Has a generic version of Fortamet been approved?

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

metformin hydrochloride tablet, extended release;oral

  • Manufacturer: LUPIN LTD
    Approval date: June 29, 2011
    Strength(s): 1GM [AB2], 500MG [AB2]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: August 1, 2012
    Strength(s): 1GM [AB2], 500MG [AB2]

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

  • Controlled release oral tablet having a unitary core
    Patent 6,099,859
    Issued: August 8, 2000
    Inventor(s): Cheng; Xiu Xiu & Chen; Chih-Ming & Jan; Steve & Chou; Joseph
    Assignee(s): Andrx Pharmaceuticals, Inc.
    A controlled release antihyperglycemic tablet that does not contain an expanding polymer and comprising a core containing the antihyperglycemic drug, a semipermeable membrane coating the core and at least one passageway in the membrane.
    Patent expiration dates:
    • March 20, 2018
      ✓ 
      Drug product
  • Controlled release oral tablet having a unitary core
    Patent 6,495,162
    Issued: December 17, 2002
    Inventor(s): Xiu Xiu; Cheng & Chih-Ming; Chen & Steve; Jan & Joseph; Chou
    Assignee(s): Andrx Pharmaceuticals, Inc.
    A controlled release antihyperglycemic tablet that does not contain an expanding polymer and comprising a core containing the antihyperglycemic drug, a semipermeable membrane coating the core and at least one passageway in the membrane.
    Patent expiration dates:
    • March 20, 2018
      ✓ 
      Drug product
  • Methods for treating diabetes via administration of controlled release metformin
    Patent 6,790,459
    Issued: September 14, 2004
    Inventor(s): Xiu Xiu; Cheng & Chih-Ming; Chen & Steve; Jan & Joseph; Chou
    Assignee(s): Andrx Labs, LLC
    A method for treating patients having non-insulin-dependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a biguanide drug such as metformin, on a once-a-day basis. The dosage form provides a mean time to maximum plasma concentration (Tmax) of the drug which occurs at a 5.5 to 7.5 hours after oral administration on a once-a-day basis to human patients. Preferably, the dose of drug is administered at dinnertime to a patient in the fed state.
    Patent expiration dates:
    • March 17, 2021
      ✓ 
      Patent use: METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
  • Controlled release metformin compositions
    Patent 6,866,866
    Issued: March 15, 2005
    Inventor(s): Chen; Chih-Ming & Cheng; Xiu-Xiu & Jan; Steve & Chou; Joseph
    Assignee(s): Andrx Labs, LLC
    A composition for treating patients having non-insulin-dependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a biguanide drug such as metformin, on a once-a-day basis. The dosage form provides a mean time to maximum plasma concentration (Tmax) of the drug which occurs at 5.5 to 7.5 hours after oral administration on a once-a-day basis to human patients. Preferably, the dose of drug is administered at dinnertime to a patient in the fed state.
    Patent expiration dates:
    • March 17, 2021
      ✓ 
      Drug product
  • Controlled release metformin formulations
    Patent 7,919,116
    Issued: April 5, 2011
    Inventor(s): Chen; Chih-Ming & Cheng; Xiu Xiu & Jan; Steve & Chou; Joseph
    Assignee(s): Andrx Labs, LLC
    Sustained release pharmaceutical formulations comprising an antihyperglycemic drug or a pharmaceutically acceptable salt thereof are disclosed. The formulations provide therapeutic plasma levels of the antihyperglycemic drug to a human patient over a 24 hour period after administration.
    Patent expiration dates:
    • March 20, 2018
      ✓ 
      Drug product
  • Controlled release metformin formulations
    Patent 8,475,841
    Issued: July 2, 2013
    Assignee(s): Andrx Labs, LLC
    Sustained release pharmaceutical formulations comprising an antihyperglycemic drug or a pharmaceutically acceptable salt thereof are disclosed. The formulations provide therapeutic plasma levels of the antihyperglycemic drug to a human patient over a 24 hour period after administration.
    Patent expiration dates:
    • March 20, 2018
      ✓ 
      Patent use: METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION

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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