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Last Updated: November 27, 2022

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.

Drug Prices for testosterone

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Drug Sales Revenue Trends for testosterone

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Recent Clinical Trials for testosterone

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

SponsorPhase
Georgios PapadakisPhase 3
Johns Hopkins Bloomberg School of Public HealthPhase 2
University of California, San DiegoPhase 2

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Generic filers with tentative approvals for TESTOSTERONE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing30MG/1.5ML ACTUATIONSOLUTION, METERED;TRANSDERMAL
See Plans and PricingSee Plans and Pricing750MG/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 ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for testosterone
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
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

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

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

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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
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Express Scripts
Colorcon
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.