Testosterone - Generic Drug Details

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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 Operations, Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Upsher Smith Labs, Ani Pharms, Strides Pharma, Dr Reddys, Watson Labs, Eli Lilly And Co, Apotex, Cipla, Lupin Ltd, Auxilium Pharms Llc, Pfizer, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Azurity, Endo Pharms, Nexus, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Tolmar, Marius Pharms Llc, and Verity, and is included in seventy-six NDAs. There are seventy-six 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 twenty patent family members in thirty-nine countries.

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

Summary for testosterone

International Patents:	120
US Patents:	76
Tradenames:	22
Applicants:	45
NDAs:	76
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	1,045
Patent Applications:	7,232
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

Drug Sales Revenue Trends for testosterone

See drug sales revenues for testosterone

Recent Clinical Trials for testosterone

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

Sponsor	Phase
Morten Hostrup, PhD	N/A
VA Office of Research and Development	Early Phase 1
Jonsson Comprehensive Cancer Center	Phase 2

See all testosterone clinical trials

Generic filers with tentative approvals for TESTOSTERONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL
⤷ Sign Up	⤷ Sign Up	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

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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
Padagis Us	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	040530-001	Jan 31, 2005	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hikma Farmaceutica	TESTOSTERONE ENANTHATE	testosterone enanthate	INJECTABLE;INJECTION	091120-001	Sep 18, 2012	AO	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 testosterone

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-001	Oct 12, 1993	⤷ Sign Up	⤷ Sign Up
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-001	Oct 12, 1993	⤷ Sign Up	⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-001	Feb 28, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for testosterone

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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 testosterone

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007044976		⤷ Sign Up
Norway	338665		⤷ Sign Up
Eurasian Patent Organization	200900987	ИНСТРУМЕНТ ДЛЯ НАНЕСЕНИЯ ОБЪЕМА ЖИДКОСТИ НА ОБРАБАТЫВАЕМУЮ ПОВЕРХНОСТЬ, СИСТЕМА И СПОСОБ ТРАНСДЕРМАЛЬНОГО ВВЕДЕНИЯ ФИЗИОЛОГИЧЕСКИ АКТИВНОГО ВЕЩЕСТВА В ОРГАНИЗМ БОЛЬНОГО	⤷ Sign Up
Japan	4616270		⤷ Sign Up
European Patent Office	1530965	Composition à liberation prolongée pour application nasale comprenant des hormones sexuelles (Controlled release delivery system of sexual hormones for nasal application)	⤷ Sign Up
Japan	5728508		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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