ANDROGEL Drug Patent Profile

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Which patents cover Androgel, and what generic alternatives are available?

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. Nineteen 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 27^th, 2006.

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Summary for ANDROGEL

International Patents:	45
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	55
Patent Applications:	4,284
Drug Prices:	Drug price information for ANDROGEL
Drug Sales Revenues:	Drug sales revenues for ANDROGEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANDROGEL
What excipients (inactive ingredients) are in ANDROGEL?	ANDROGEL excipients list
DailyMed Link:	ANDROGEL at DailyMed

Drug patent expirations by year for ANDROGEL

Recent Clinical Trials for ANDROGEL

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

Sponsor	Phase
VA Office of Research and Development	Phase 2
University Medical Center Groningen	N/A
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4

See all ANDROGEL clinical trials

Pharmacology for ANDROGEL

Drug Class	Androgen
Mechanism of Action	Androgen 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: ⤷ Sign Up

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

Testosterone gel and method of use
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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

EU/EMA Drug Approvals for ANDROGEL

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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.

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Country	Patent Number	Title	Estimated Expiration
South Africa	200407403	Androgen pharmaceutical composition and method for treating depression	⤷ Sign Up
South Africa	200301686	Method of increasing testosterone and related steroid concentrations in women.	⤷ Sign Up
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)	⤷ Sign Up
Eurasian Patent Organization	009815	УПАКОВКА С ДОЗИРОВАННОЙ ФОРМОЙ ТЕСТОСТЕРОНОВОГО ГЕЛЯ ДЛЯ ЛЕЧЕНИЯ ГИПОГОНАДИЗМА И СПОСОБ ЕЁ ПОЛУЧЕНИЯ (TESTOSTERONE GEL IN UNIT DOSE PACKET FOR TREATING HYPOGONADISM AND METHOD FOR PREPARING THEREOF)	⤷ Sign Up
South Korea	20050074896		⤷ Sign Up
Norway	20082170		⤷ Sign Up
Norway	20200014	Forbedret testosterongel og fremgangsmåte til anvendelse	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration