Generic Glucophage XR Availability

See also: Generic Glucophage

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

GLUCOPHAGE XR (metformin hydrochloride - tablet, extended release;oral)

Has a generic version of Glucophage XR been approved?

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

metformin hydrochloride tablet, extended release;oral

  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: June 16, 2004
    Strength(s): 500MG [AB1]
  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: April 12, 2005
    Strength(s): 750MG [AB]
  • Manufacturer: AMNEAL PHARMS NY
    Approval date: January 3, 2008
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: APOTEX
    Approval date: December 14, 2004
    Strength(s): 500MG [AB1]
  • Manufacturer: APOTEX
    Approval date: December 29, 2005
    Strength(s): 750MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: July 20, 2012
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: BARR
    Approval date: October 14, 2004
    Strength(s): 750MG [AB]
  • Manufacturer: CSPC OUYI PHARM CO
    Approval date: April 17, 2008
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: IMPAX LABS
    Approval date: July 30, 2004
    Strength(s): 500MG [AB1]
  • Manufacturer: IMPAX LABS
    Approval date: September 13, 2005
    Strength(s): 750MG [AB]
  • Manufacturer: INVENTIA HLTHCARE
    Approval date: January 18, 2012
    Strength(s): 500MG [AB1]
  • Manufacturer: MYLAN
    Approval date: September 8, 2005
    Strength(s): 750MG [AB]
  • Manufacturer: MYLAN
    Approval date: September 13, 2005
    Strength(s): 500MG [AB1]
  • Manufacturer: NOSTRUM PHARMS LLC
    Approval date: July 26, 2006
    Strength(s): 500MG [AB1]
  • Manufacturer: NOSTRUM PHARMS LLC
    Approval date: December 12, 2011
    Strength(s): 750MG [AB]
  • Manufacturer: SANDOZ
    Approval date: December 14, 2004
    Strength(s): 500MG [AB1]
  • Manufacturer: SUN PHARM INDS (IN)
    Approval date: February 9, 2006
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: TEVA
    Approval date: June 18, 2004
    Strength(s): 500MG [AB1]
  • Manufacturer: TEVA
    Approval date: April 12, 2005
    Strength(s): 750MG [AB]
  • Manufacturer: TORRENT PHARM
    Approval date: December 30, 2009
    Strength(s): 500MG [AB1]
  • Manufacturer: ZYDUS PHARMS USA
    Approval date: April 20, 2005
    Strength(s): 500MG [AB1]
  • Manufacturer: ZYDUS PHARMS USA
    Approval date: April 21, 2005
    Strength(s): 750MG [AB]

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

  • Biphasic controlled release delivery system for high solubility pharmaceuticals and method
    Patent 6,475,521
    Issued: November 5, 2002
    Inventor(s): Peter; Timmins & Andrew B.; Dennis & Kiren A.; Vyas
    Assignee(s): Bristol-Myers Squibb Co.
    A biphasic controlled release delivery system for pharmaceuticals which have high water solubility, such as the antidiabetic metformin HCl salt, is provided which provides a dosage form that has prolonged gastric residence so that a dosing regimen of at least one gram metformin, once daily, may be achieved while providing effective control of plasma glucose. The delivery system includes (1) an inner solid particulate phase formed of substantially uniform granules containing a pharmaceutical having a high water solubility, and one or more hydrophilic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, and (2) an outer solid continuous phase in which the above granules of inner solid particulate phase are embedded and dispersed throughout, the outer solid continuous phase including one or more hydrophilic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, which may be compressed into tablets or filled into capsules. Methods for forming the so-described biphasic controlled release delivery system and using such biphasic controlled release delivery system for treating diabetes are also provided.
    Patent expiration dates:
    • March 19, 2018
  • Method of use of a biphasic controlled release delivery system for high solubility pharmaceuticals and method
    Patent 6,660,300
    Issued: December 9, 2003
    Inventor(s): Peter; Timmins & Andrew B.; Dennis & Kiren A.; Vyas
    Assignee(s): Bristol-Myers Squibb Co.
    A biphasic controlled release delivery system for pharmaceuticals which have high water solubility, such as the antidiabetic metformin HCl salt, is provided which provides a dosage form that has prolonged gastric residence so that a dosing regimen of at least one gram metformin, once daily, may be achieved while providing effective control of plasma glucose. The delivery system includes (1) an inner solid particulate phase formed of substantially uniform granules containing a pharmaceutical having a high water solubility, and one or more hydrophilic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, and (2) an outer solid continuous phase in which the above granules of inner solid particulate phase are embedded and dispersed throughout, the outer solid continuous phase including one or more hydrophobic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, which may be compressed into tablets or filled into capsules. Methods for forming the so-described biphasic controlled release delivery system and using such biphasic controlled release delivery system for treating diabetes are also provided.
    Patent expiration dates:
    • March 19, 2018
      ✓ 
      Patent use: METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES 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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