Generic AndroGel Availability
Last updated on Oct 9, 2024.
AndroGel is a brand name of testosterone, approved by the FDA in the following formulation(s):
ANDROGEL (testosterone - gel, metered;transdermal)
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Manufacturer: BESINS HLTHCARE
Approval date: September 26, 2003
Strength(s): 12.5MG/1.25GM ACTUATION (discontinued) [RLD] -
Manufacturer: BESINS HLTHCARE
Approval date: April 29, 2011
Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [RLD] [AB]
ANDROGEL (testosterone - gel;transdermal)
-
Manufacturer: BESINS HLTHCARE
Approval date: February 28, 2000
Strength(s): 25MG/2.5GM PACKET (discontinued) [RLD], 50MG/5GM PACKET (discontinued) [RLD] -
Manufacturer: BESINS HLTHCARE
Approval date: September 7, 2012
Strength(s): 1.62% (20.25MG/1.25GM PACKET) (discontinued) [RLD], 1.62% (40.5MG/2.5GM PACKET) (discontinued) [RLD]
Has a generic version of AndroGel been approved?
A generic version of AndroGel 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 AndroGel and have been approved by the FDA:
testosterone gel, metered;transdermal
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Manufacturer: ACTAVIS LABS UT INC
Approval date: April 10, 2019
Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [AB] -
Manufacturer: AMNEAL
Approval date: April 10, 2019
Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [AB] -
Manufacturer: ENCUBE
Approval date: April 10, 2019
Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [AB] -
Manufacturer: LUPIN
Approval date: April 10, 2019
Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [AB] -
Manufacturer: PADAGIS ISRAEL
Approval date: August 4, 2015
Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [AB] -
Manufacturer: TWI PHARMS
Approval date: September 23, 2019
Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [AB] -
Manufacturer: XIROMED
Approval date: April 16, 2020
Strength(s): 1.62% (20.25MG/1.25GM ACTUATION) [AB]
Note: No generic formulation of the following product is available.
- testosterone - gel;transdermal
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: Generic Drug FAQ.
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.
-
Testosterone gel and method of use
Patent 8,466,136
Issued: June 18, 2013
Inventor(s): Malladi Ramana & Stahlman JodiThe 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✓
- October 12, 2026
-
Testosterone gel and method of use
Patent 8,466,137
Issued: June 18, 2013
Inventor(s): Malladi Ramana & Stahlman JodiThe 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✓
- October 12, 2026
-
Testosterone gel and method of use
Patent 8,466,138
Issued: June 18, 2013
Inventor(s): Malladi Ramana & Miller JodiThe 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✓
- October 12, 2026
-
Testosterone gel and method of use
Patent 8,486,925
Issued: July 16, 2013
Inventor(s): Malladi Ramana & Miller JodiThe 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✓
- October 12, 2026
-
Testosterone gel and method of use
Patent 8,729,057
Issued: May 20, 2014
Inventor(s): Malladi Ramana & Stahlman JodiThe 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✓
- October 12, 2026
-
Testosterone gel and method of use
Patent 8,741,881
Issued: June 3, 2014
Inventor(s): Malladi Ramana & Stahlman JodiThe 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✓
- October 12, 2026
-
Testosterone gel and method of use
Patent 8,754,070
Issued: June 17, 2014
Inventor(s): Malladi Ramana & Stahlman JodiThe 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✓
- October 12, 2026
-
Testosterone gel and method of use
Patent 8,759,329
Issued: June 24, 2014
Inventor(s): Malladi Ramana & Stahlman JodiThe 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✓
- October 12, 2026
More about AndroGel (testosterone)
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Glossary
Term | Definition |
---|---|
Drug Patent | A 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 Exclusivity | Exclusivity 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. |
RLD | A 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. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.