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Last Updated: April 19, 2024

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 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, Eugia Pharma, 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, Verity, and Endo Pharms Inc, and is included in seventy-six NDAs. There are seventy-five 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. Twenty suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for testosterone

International Patents:	120
US Patents:	75
Tradenames:	22
Applicants:	47
NDAs:	76
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	1,020
Patent Applications:	6,869
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
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
⤷ Try a Trial	⤷ Try a Trial	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL
⤷ Try a Trial	⤷ Try a Trial	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
Slayback Pharma Llc	TESTOSTERONE CYPIONATE	testosterone cypionate	SOLUTION;INTRAMUSCULAR	216318-001	Jun 2, 2022		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995	⤷ Try a Trial	⤷ Try a Trial
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995	⤷ Try a Trial	⤷ Try a Trial
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-002	Oct 12, 1993	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	⤷ Try a Trial	⤷ Try a Trial
>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
Canada	2624788	GEL AMELIORE A BASE DE TESTOSTERONE ET PROCEDE D'UTILISATION (IMPROVED TESTOSTERONE GEL AND METHOD OF USE)	⤷ Try a Trial
South Korea	100861443		⤷ Try a Trial
Poland	379867	Układ dostarczania o kontrolowanym uwalnianiu do podawania donosowego (CONTROLLED RELEASE DELIVERY SYSTEM FOR NASAL APPLICATIONS)	⤷ Try a Trial
Canada	2857286	COMPOSITIONS DE GEL DE TESTOSTERONE ET PROCEDES CONNEXES (TESTOSTERONE GEL COMPOSITIONS AND RELATED METHODS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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