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Generic Glumetza Availability

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

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

  • Manufacturer: SANTARUS INC
    Approval date: June 3, 2005
    Strength(s): 1GM [RLD] [AB3], 500MG [RLD] [AB3]

Has a generic version of Glumetza been approved?

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

metformin hydrochloride tablet, extended release;oral

  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: August 1, 2016
    Strength(s): 1GM [AB3], 500MG [AB3]
  • Manufacturer: LUPIN LTD
    Approval date: July 19, 2013
    Strength(s): 1GM [AB3], 500MG [AB3]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: August 1, 2016
    Strength(s): 1GM [AB3], 500MG [AB3]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Glumetza. 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: Generic Drug FAQs.

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.

  • Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
    Patent 6,488,962
    Issued: December 3, 2002
    Inventor(s): Bret; Berner & Jenny; Louie-Helm
    Assignee(s): DepoMed, Inc.
    The retention of oral drug dosage forms in the stomach is improved by using swellable dosage forms that are shaped in a manner that will prevent them from inadvertently passing through the pylorus as a result of being in a particular orientation. The planar projection of the shape is one that has two orthogonal axes of different lengths, the longer being short enough to permit easy swallowing prior to swelling while the shorter is long enough within one-half hour of swelling to prevent passage through the pylorus.
    Patent expiration dates:
    • June 20, 2020
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  • Optimal polymer mixtures for gastric retentive tablets
    Patent 6,723,340
    Issued: April 20, 2004
    Inventor(s): Gloria; Gusler & Bret; Berner & Mei; Chau & Aimee; Padua
    Assignee(s): DepoMed, Inc.
    Unit dosage form tablets for the delivery of pharmaceuticals are formed of the pharmaceutical dispersed in a solid unitary matrix that is formed of a combination of poly(ethylene oxide) and hydroxypropyl methylcellulose. The combination offers unique benefits in terms of release rate control and reproducibility while allowing both swelling of the tablet to effect gastric retention and gradual disintegration of the tablet to clear the tablet from the gastrointestinal tract after release of the drug has occurred.
    Patent expiration dates:
    • October 25, 2021
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  • Controlled release dosage forms
    Patent 7,780,987
    Issued: August 24, 2010
    Inventor(s): Zhou; Fang & Maes; Paul
    Assignee(s): Biovail Laboratories International SRL
    The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.
    Patent expiration dates:
    • March 23, 2025
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  • Controlled release dosage forms
    Patent 8,323,692
    Issued: December 4, 2012
    Inventor(s): Frisbee; Steven
    Assignee(s): Valeant International Bermuda
    The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.
    Patent expiration dates:
    • March 30, 2023
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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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