ANDROGEL Drug Patent Profile

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 27^th, 2006.

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:	54
Patent Applications:	6,646
Formulation / Manufacturing:	see details
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

See drug prices for ANDROGEL

See drug sales revenues for ANDROGEL

Recent Clinical Trials for ANDROGEL

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

Sponsor	Phase
University Medical Center Groningen	N/A
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
Harvard University	Phase 4

See all ANDROGEL clinical trials

Pharmacology for ANDROGEL

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ANDROGEL

G03BA	3-oxoandrosten (4) derivatives
G03B	ANDROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for ANDROGEL

ANDROGEL is protected by eight US patents.

Patents protecting ANDROGEL

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

Expired US Patents for ANDROGEL

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

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

International Patents for ANDROGEL

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

Country	Patent Number	Title	Estimated Expiration
Australia	9059801
Eurasian Patent Organization	007431	АНДРОГЕННАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБ ДЛЯ ЛЕЧЕНИЯ ДЕПРЕССИИ (ANDROGEN PHARMACEUTICAL COMPOSITION AND METHODS FOR TREATING DEPRESSION)
European Patent Office	1315502	METHODE POUR TRAITER LA DYSERECTION ET AUGMENTER LA LIBIDO CHEZ L'HOMME (METHOD FOR TREATING ERECTILE DYSFUNCTION AND INCREASING LIBIDO IN MEN)
Canada	2502607
Israel	154692
European Patent Office	1322336	PROCÉDÉ POUR AUGMENTER LA CONCENTRATION DE TESTOSTÉRONE ET DE STÉROIDES APPARENTÉS CHEZ LA FEMME (METHOD OF INCREASING TESTOSTERONE AND RELATED STEROID CONCENTRATIONS IN WOMEN)
Japan	2009511602