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Last Updated: July 21, 2024

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, Slayback Pharma Llc, 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-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-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
Jonsson Comprehensive Cancer CenterPhase 2
QuantumLeap Healthcare CollaborativePhase 2
Pakistan Science FoundationPhase 1

See all TESTOSTERONE clinical trials

Generic filers with tentative approvals for TESTOSTERONE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up30MG/1.5ML ACTUATIONSOLUTION, METERED;TRANSDERMAL
⤷  Sign Up⤷  Sign Up750MG/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 ClassAndrogen
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
Lilly TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 080254-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 040615-002 Aug 10, 2006 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
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 ⤷  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 019762-002 Oct 12, 1993 ⤷  Sign Up ⤷  Sign Up
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 ⤷  Sign Up ⤷  Sign Up
>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
Russian Federation 2006120468 СИСТЕМА ДОСТАВКИ С КОНТРОЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ НАЗАЛЬНОГО ПРИМЕНЕНИЯ ⤷  Sign Up
Argentina 047722 SISTEMA DE TRANFERENCIA DE LIBERACION CONTROLADA PARA APLICACIONES NASALES ⤷  Sign Up
Canada 2674661 INSTRUMENT D'ETALEMENT (SPREADING IMPLEMENT) ⤷  Sign Up
South Korea 20060109903 CONTROLLED RELEASE DELIVERY SYSTEM FOR NASAL APPLICATIONS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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