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Last Updated: May 28, 2022

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 Abbvie and is included in two NDAs. There are eight patents protecting this drug.

This drug has forty-four 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 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

Identify potential brand extensions & 505(b)(2) entrants

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 Class Androgen
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Testosterone gel and method of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Testosterone gel and method of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Testosterone gel and method of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Testosterone gel and method of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-002 Feb 28, 2000 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ANDROGEL

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

Country Patent Number Title Estimated Expiration
Israel 215944 שימוש בתכשיר המכיל טסטוסטרון להכנת תרופה לטיפול במחסור בטסטוסטרון (Use of a testosterone comprising pharmaceutical composition in the preparation of medicament for treating a testosterone deficiency) See Plans and Pricing
Ukraine 87627 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ В ВИДЕ ТЕСТОСТЕРОНОВОГО ГЕЛЯ И ЕЕ ИСПОЛЬЗОВАНИЕ ПРИ ЛЕЧЕНИИ ГИПОГОНАДИЗМА У МУЖЧИН;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ У ВИГЛЯДІ ТЕСТОСТЕРОНОВОГО ГЕЛЮ ТА ЙОГО ЗАСТОСУВАННЯ ПРИ ЛІКУВАННІ ГІПОГОНАДИЗМУ В ЧОЛОВІКІВ (TESTOSTERONE GEL FORMULATION AND ITS USE FOR TREATING HYPOGONADISM IN MAN) See Plans and Pricing
Mexico PA05004093 METODO PARA EL TRATAMIENTO DE LA DISFUNCION ERECTIL E INCREMENTO EN EL LIBIDO DEL HOMBRE. (METHOD FOR TREATING ERECTILE DYSFUNCTION AND INCREASING LIBIDO IN MEN.) See Plans and Pricing
Portugal 1937276 See Plans and Pricing
Japan 2009511602 See Plans and Pricing
New Zealand 524601 Method for treating erectile dysfunction and increasing libido in men See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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