Testosterone - Generic Drug Details

What are the generic drug sources for testosterone and what is the scope of freedom to operate?

Testosterone is the generic ingredient in twenty-two branded drugs marketed by Abbvie, Alza, Acerus, Besins Hlthcare, Endo Pharms, Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Upsher Smith Labs, Auxilium Pharms Llc, Ani Pharms, Strides Pharma, Dr Reddys, Watson Labs, Auxilium Pharms Inc, Eli Lilly And Co, Apotex, Cipla, Dash Pharms, Lupin Ltd, Pfizer, Am Regent, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Slayback Pharma Llc, Nexus, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Tolmar, Marius Pharms Llc, and Endo Pharms Inc, and is included in seventy-four NDAs. There are eighty-four patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Testosterone has one hundred and eighty-five patent family members in forty-two countries.

There are sixty-nine drug master file entries for testosterone. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for testosterone

International Patents:	185
US Patents:	84
Tradenames:	22
Applicants:	45
NDAs:	74
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	1,020
Patent Applications:	7,239
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for testosterone
Drug Sales Revenues:	Drug sales revenues for testosterone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for testosterone
What excipients (inactive ingredients) are in testosterone?	testosterone excipients list
DailyMed Link:	testosterone at DailyMed

See drug prices for testosterone

See drug sales revenues for testosterone

Recent Clinical Trials for testosterone

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

Sponsor	Phase
Myovant Sciences GmbH	Phase 2
Legorreta Cancer Center at Brown University	Phase 1
Brown University	Phase 1

See all testosterone clinical trials

Generic filers with tentative approvals for TESTOSTERONE

Applicant	Application No.	Strength	Dosage Form
		30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL
		750MG/3ML (250MG/ML)	INJECTABLE;INTRAMUSCULAR

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for testosterone

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for testosterone

Androgens

Anatomical Therapeutic Chemical (ATC) Classes for testosterone

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

Paragraph IV (Patent) Challenges for TESTOSTERONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXIRON	Topical Solution	testosterone	30 mg/1.5 mL	022504	1	2013-01-29
FORTESTA	Gel	testosterone	10 mg/actuation	021463	1	2012-08-14
TESTIM	Gel	testosterone	1%	021454	1	2008-08-21

US Patents and Regulatory Information for testosterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No			Y
Auxilium Pharms Llc	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	AB2	RX	Yes	Yes
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes			Y
Strides Pharma	TESTOSTERONE	testosterone	GEL;TRANSDERMAL	076744-002	May 23, 2007	AB1	RX	No	No
Antares Pharma Inc	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes

Expired US Patents for testosterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997
Auxilium Pharms Llc	STRIANT	testosterone	TABLET, EXTENDED RELEASE;BUCCAL	021543-001	Jun 19, 2003
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	021015-003	Sep 26, 2003
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997

EU/EMA Drug Approvals for testosterone

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 testosterone

Country	Patent Number	Title	Estimated Expiration
Brazil	0312007	Controle de taxa de administração transcutânea usando composições farmacêuticas amorfas
Israel	190522	תכשיר רפואי המכיל ג'ל טסטוסטרון הידרואלכוהולי ושימוש בטסטוסטרון ליצור התכשיר (Hydroalcoholic testosterone gel pharmaceutical composition and the use of testosterone for the manufacture of a composition)
China	1662243	Pharmaceutical composition
South Africa	200711040	Method and composition for transdermal drug delivery
Georgia, Republic of	P20125432	IMPROVED TESTOSTERONE GEL AND USE THEREOF