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Last Updated: March 18, 2024

ANDROGEL Drug Patent Profile


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Which patents cover Androgel, and when can generic versions of Androgel launch?

Androgel is a drug marketed by Besins Hlthcare and is included in two NDAs. There are eight patents protecting this drug.

This drug has forty-five patent family members in twenty-nine countries.

The generic ingredient in ANDROGEL is testosterone. There are sixty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the testosterone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Androgel

A generic version of ANDROGEL was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.

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Drug patent expirations by year for ANDROGEL
Drug Prices for ANDROGEL

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Drug Sales Revenue Trends for ANDROGEL

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Recent Clinical Trials for ANDROGEL

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SponsorPhase
University Medical Center GroningenN/A
Cedars-Sinai Medical CenterPhase 4
National Heart, Lung, and Blood Institute (NHLBI)Phase 4

See all ANDROGEL clinical trials

Pharmacology for ANDROGEL
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists

US Patents and Regulatory Information for ANDROGEL

ANDROGEL is protected by eight US patents.

Patents protecting ANDROGEL

Testosterone gel and method of use
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Patent Expiration: ⤷  Try a Trial

Testosterone gel and method of use
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Patent Expiration: ⤷  Try a Trial
Patented Use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

Testosterone gel and method of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

Testosterone gel and method of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Testosterone gel and method of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Testosterone gel and method of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

Testosterone gel and method of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Testosterone gel and method of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ANDROGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 021015-002 Feb 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 021015-003 Sep 26, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ANDROGEL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Warner Chilcott UK Ltd. Intrinsa testosterone EMEA/H/C/000634
Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Withdrawn no no no 2006-07-28
Warner Chilcott  Deutschland GmbH Livensa testosterone EMEA/H/C/000630
Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Withdrawn no no no 2006-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ANDROGEL

See the table below for patents covering ANDROGEL around the world.

Country Patent Number Title Estimated Expiration
Spain 2399763 ⤷  Try a Trial
South Africa 200407403 Androgen pharmaceutical composition and method for treating depression ⤷  Try a Trial
Brazil 0113670 ⤷  Try a Trial
Norway 20044342 ⤷  Try a Trial
Lithuania 2450041 ⤷  Try a Trial
Canada 2420895 METHODE POUR TRAITER LA DYSERECTION ET AUGMENTER LA LIBIDO CHEZ L'HOMME (METHOD FOR TREATING ERECTILE DYSFUNCTION AND INCREASING LIBIDO IN MEN) ⤷  Try a Trial
Australia 2003277388 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.