Testosterone - Generic Drug Details

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

Testosterone is the generic ingredient in twenty-two branded drugs marketed by Allergan, Alza, Acerus, Abbvie, Endo Pharms, Actavis Labs Ut Inc, Aleor Dermaceuticals, Amneal, Dr Reddys, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Upsher Smith Labs, Auxilium Pharms Llc, Ani Pharms, Encube, Strides Pharma, 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 Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Slayback Pharma Llc, Nexus Pharms, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Clarus, Marius Pharms Llc, and Endo Pharms Inc, and is included in seventy-three NDAs. There are seventy-seven 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-two 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:	182
US Patents:	77
Tradenames:	22
Applicants:	45
NDAs:	73
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	997
Patent Applications:	7,160
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

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
Georgios Papadakis	Phase 3
Johns Hopkins Bloomberg School of Public Health	Phase 2
University of California, San Diego	Phase 2

See all testosterone clinical trials

Generic filers with tentative approvals for TESTOSTERONE

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL
See Plans and Pricing	See Plans and Pricing	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

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
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Auxilium Pharms Llc	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	AB2	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Sandoz Inc	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	040615-001	Aug 10, 2006	AO	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	See Plans and Pricing	See Plans and Pricing
Endo Pharms	FORTESTA	testosterone	GEL, METERED;TRANSDERMAL	021463-001	Dec 29, 2010	See Plans and Pricing	See Plans and Pricing
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-001	Oct 12, 1993	See Plans and Pricing	See Plans and Pricing
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	See Plans and Pricing	See Plans and Pricing
>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
Mexico	2007015255	METODO Y COMPOSICION PARA ADMINISTRACION TRANSDERMICA DE UN FARMACO. (METHOD AND COMPOSITION FOR TRANSDERMAL DRUG DELIVERY.)	See Plans and Pricing
Spain	2589077		See Plans and Pricing
Brazil	0312007	Controle de taxa de administração transcutânea usando composições farmacêuticas amorfas	See Plans and Pricing
China	102091079	Method and composition for transdermal drug delivery	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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