TESTIM Drug Patent Profile

When do Testim patents expire, and what generic alternatives are available?

Testim is a drug marketed by Endo Operations and is included in one NDA.

The generic ingredient in TESTIM 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 Testim

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

Summary for TESTIM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
Patent Applications:	4,809
Drug Prices:	Drug price information for TESTIM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TESTIM
What excipients (inactive ingredients) are in TESTIM?	TESTIM excipients list
DailyMed Link:	TESTIM at DailyMed

See drug prices for TESTIM

See drug sales revenues for TESTIM

Recent Clinical Trials for TESTIM

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

Sponsor	Phase
Endo Pharmaceuticals	Phase 4
Instituto de Investigacion Sanitaria La Fe	Phase 3
Marianne Andersen	Phase 4

See all TESTIM clinical trials

Pharmacology for TESTIM

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Paragraph IV (Patent) Challenges for TESTIM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TESTIM	Gel	testosterone	1%	021454	1	2008-08-21

US Patents and Regulatory Information for TESTIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	AB2	RX	Yes	Yes

Expired US Patents for TESTIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002

EU/EMA Drug Approvals for TESTIM

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 TESTIM

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

Country	Patent Number	Title	Estimated Expiration
Poland	372083	Kompozycja farmaceutyczna (PHARMACEUTICAL COMPOSITION)
Eurasian Patent Organization	009839	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ УСИЛЕНИЯ ТРАНСДЕРМАЛЬНОЙ ДОСТАВКИ АНДРОГЕНА И СПОСОБЫ ЕЕ ПРИМЕНЕНИЯ (PHARMACEUTICAL COMPOSITION FOR ENHANCING TRANSDERMAL DELIVERY OF ANDROGEN AND METHOD FOR USE THEREOF)
Denmark	1425019

Supplementary Protection Certificates for TESTIM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
8703473	91289	Luxembourg		PRODUCT NAME: TESTIM; REGISRATION NO 1768/92