ANDROGEL Drug Patent Profile

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 27^th, 2006.

Summary for ANDROGEL

International Patents:	44
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	54
Patent Applications:	4,319
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
Cedars-Sinai Medical Center	Phase 4
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

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

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
Abbvie	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012
Abbvie	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-001	Feb 28, 2000
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012

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)
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)
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.)
Portugal	1937276
Japan	2009511602
New Zealand	524601	Method for treating erectile dysfunction and increasing libido in men