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], 500MG

Has a generic version of Glumetza been approved?

No. There is currently no therapeutically equivalent version of Glumetza available in the United States.

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: 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.

  • Extending the duration of drug release within the stomach during the fed mode
    Patent 6,340,475
    Issued: January 22, 2002
    Inventor(s): John W.; Shell & Jenny; Louie-Helm & Micheline; Markey
    Assignee(s): DepoMed, Inc.
    Drugs are formulated as unit oral dosage forms by incorporating them into polymeric matrices comprised of hydrophilic polymers that swell upon imbibition of water to a size that is large enough to promote retention of the dosage form in the stomach during the fed mode. The oral formulation is designed for gastric retention and controlled delivery of an incorporated drug into the gastric cavity, and thus administered, the drug is released from the matrix into the gastric fluid by solution diffusion. The swollen polymeric matrix, having achieved sufficient size, remains in the gastric cavity for several hours if administered while the patient is in the fed mode, and remains intact long enough for substantially all of the drug to be released before substantial dissolution of the matrix occurs. The swelling matrix lowers the accessibility of the gastric fluid to the drug and thereby reduces the drug release rate. This process, together with diffusion retardation by selection of specific polymers, polymer molecular weights, and other variables, results in a sustained and controlled delivery rate of the drug to the gastric cavity.
    Patent expiration dates:
    • September 19, 2016
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      Patent use: INDICATION OF TYPE II DIABETES
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  • 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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  • Extending the duration of drug release within the stomach during the fed mode
    Patent 6,635,280
    Issued: October 21, 2003
    Inventor(s): John W.; Shell & Jenny; Louie-Helm & Micheline; Markey
    Assignee(s): DepoMed, Inc.
    Drugs are formulated as unit oral dosage forms by incorporating them into polymeric matrices comprised of hydrophilic polymers that swell upon imbibition of water to a size that is large enough to promote retention of the dosage form in the stomach during the fed mode. The oral formulation is designed for gastric retention and controlled delivery of an incorporated drug into the gastric cavity, and thus administered, the drug is released from the matrix into the gastric fluid by solution diffusion. The swollen polymeric matrix, having achieved sufficient size, remains in the gastric cavity for several hours if administered while the patient is in the fed mode, and remains intact long enough for substantially all of the drug to be released before substantial dissolution of the matrix occurs. The swelling matrix lowers the accessibility of the gastric fluid to the drug and thereby reduces the drug release rate. This process, together with diffusion retardation by selection of specific polymers, polymer molecular weights, and other variables, results in a sustained and controlled delivery rate of the drug to the gastric cavity.
    Patent expiration dates:
    • September 19, 2016
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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 23, 2025
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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.
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