Generic AndroGel Availability

See also: Generic Androderm

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

ANDROGEL (testosterone - gel, metered;transdermal)

  • Manufacturer: ABBVIE
    Approval date: September 26, 2003
    Strength(s): 1% (12.5MG/1.25GM ACTUATION) [RLD]
  • Manufacturer: ABBVIE
    Approval date: April 29, 2011
    Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [RLD]

ANDROGEL (testosterone - gel;transdermal)

  • Manufacturer: ABBVIE
    Approval date: February 28, 2000
    Strength(s): 1% (25MG/2.5GM PACKET)
  • Manufacturer: ABBVIE
    Approval date: September 7, 2012
    Strength(s): 1.62% (20.25MG/1.25GM PACKET), 1.62% (40.5MG/2.5GM PACKET) [RLD]

Has a generic version of AndroGel been approved?

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

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

  • Pharmaceutical composition and method for treating hypogonadism
    Patent 6,503,894
    Issued: January 7, 2003
    Inventor(s): Robert E.; Dudley & S. George; Kottayil & Olivier; Palatchi
    Assignee(s): Unimed Pharmaceuticals, Inc. Laboratories Besins Iscovesco
    A pharmaceutical composition useful for treating hypogonadism is disclosed. The composition comprises an androgenic or anabolic steroid, a C1-C4 alcohol, a penetration enhancer such as isopropyl myristate, and water. Also disclosed is a method for treating hypogonadism utilizing the composition.
    Patent expiration dates:
    • August 30, 2020
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
    • August 30, 2020
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
    • March 1, 2021
      ✓ 
      Pediatric exclusivity
  • Testosterone gel and method of use
    Patent 8,466,136
    Issued: June 18, 2013
    Assignee(s): Unimed Pharmaceuticals, LLC Laboratoires Besins International, SAS
    The present invention relates to an improved transdermal hydroalcoholic testosterone gen formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.
    Patent expiration dates:
    • October 12, 2026
      ✓ 
      Drug product
  • Testosterone gel and method of use
    Patent 8,466,137
    Issued: June 18, 2013
    Assignee(s): Unimed Pharmaceuticals, LLC Laboratoires Besins International, SAS
    The present invention relates to an improved transdermal hydroalcoholic testosterone gen formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.
    Patent expiration dates:
    • October 12, 2026
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
  • Testosterone gel and method of use
    Patent 8,466,138
    Issued: June 18, 2013
    Assignee(s): Unimed Pharmaceuticals, LLC Laboratoires Besins International, SAS
    The present invention relates to an improved transdermal hydroalcoholic testosterone gel formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.
    Patent expiration dates:
    • October 12, 2026
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
  • Testosterone gel and method of use
    Patent 8,486,925
    Issued: July 16, 2013
    Assignee(s): Unimed Pharmaceuticals, LLC Laboratoires Besins International, SAS
    The present invention relates to an improved transdermal hydroalcoholic testosterone gel formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.
    Patent expiration dates:
    • October 12, 2026
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • April 29, 2014 - NEW 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.

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