AndroGel

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: ABBOTT LABS
  
  Approval date: September 26, 2003
  
  Strength(s): 1% (1.25GM/ACTIVATION) ^[RLD]


• 
  Manufacturer: ABBOTT LABS
  
  Approval date: April 29, 2011
  
  Strength(s): 1.62% (20.25MG/1.25GM ACTIVATION) ^[RLD]

ANDROGEL (testosterone - gel; transdermal)

• 
  Manufacturer: ABBOTT LABS
  
  Approval date: February 28, 2000
  
  Strength(s): 1% (2.5GM/PACKET)
  

Has a generic version of AndroGel been approved?

No. There is currently no therapeutically equivalent version of AndroGel available.

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
  
  

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
  
  

See also...

• Androgel Consumer Information (Drugs.com)
• AndroGel Gel Consumer Information (Wolters Kluwer)
• AndroGel 2.5 g/packet Consumer Information (Cerner Multum)
• AndroGel 5 g/packet Consumer Information (Cerner Multum)
• AndroGel Packets Consumer Information (Cerner Multum)
• AndroGel Pump 1.25 g/actuation Consumer Information (Cerner Multum)
• Androgel Advanced Consumer Information (Micromedex)
• Testosterone Consumer Information (Drugs.com)
• Testosterone Consumer Information (Wolters Kluwer)
• Testosterone Gel Consumer Information (Wolters Kluwer)
• Testosterone Patch Consumer Information (Wolters Kluwer)
• Testosterone Solution Consumer Information (Wolters Kluwer)
• Testosterone buccal system Consumer Information (Cerner Multum)
• Testosterone injection Consumer Information (Cerner Multum)
• Testosterone topical Consumer Information (Cerner Multum)
• Androplex Advanced Consumer Information (Micromedex)
• Testosterone Buccal Advanced Consumer Information (Micromedex)
• Testosterone Topical application Advanced Consumer Information (Micromedex)
• Testosterone Transdermal Advanced Consumer Information (Micromedex)
• Testosterone AHFS DI Monographs (ASHP)