Generic MetroGel Availability

See also: Generic MetroCream, Generic MetroGel-Vaginal, Generic MetroLotion

MetroGel is a brand name of metronidazole topical, approved by the FDA in the following formulation(s):

METROGEL (metronidazole - gel;topical)

Has a generic version of MetroGel been approved?

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

metronidazole gel;topical

  • Manufacturer: FOUGERA PHARMS
    Approval date: June 6, 2006
    Strength(s): 0.75% [AB]
  • Manufacturer: G AND W LABS INC
    Approval date: January 19, 2011
    Strength(s): 0.75% [AB]
  • Manufacturer: TARO
    Approval date: July 18, 2006
    Strength(s): 0.75% [AB]
  • Manufacturer: TOLMAR
    Approval date: July 13, 2006
    Strength(s): 0.75% [AB]
  • Manufacturer: TOLMAR
    Approval date: July 22, 2011
    Strength(s): 1% [AB]

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

  • Aqueous compositions containing metronidazole
    Patent 6,881,726
    Issued: April 19, 2005
    Inventor(s): Chang; Yunik & Dow; Gordon J.
    Assignee(s): Dow Pharmaceutical Sciences
    An aqueous solution of metronidazole in which the concentration of metronidazole is higher than 0.75%. The solution contains a combination of solubility-enhancing agents, one of which is a cyclodextrin such as beta-cyclodextrin and the second is a compound other than a cyclodextrin. Methods of manufacture and therapeutic use of the solution are disclosed.
    Patent expiration dates:
    • February 21, 2022
      ✓ 
      Patent use: ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
      ✓ 
      Drug product
  • Aqueous compositions containing metronidazole
    Patent 7,348,317
    Issued: March 25, 2008
    Inventor(s): Chang; Yunik & Dow; Gordon J.
    Assignee(s): Dow Pharmaceutical Sciences
    An aqueous solution of metronidazole in which the concentration of metronidazole is higher than 0.75%. The solution contains a combination of solubility-enhancing agents, one of which is a cyclodextrin such as beta-cyclodextrin and the second is niacin or niacinamide. Methods of manufacture and therapeutic use of the solution are disclosed.
    Patent expiration dates:
    • February 21, 2022
      ✓ 
      Patent use: ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
      ✓ 
      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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