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Last Updated: March 18, 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-five 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 sixty-six 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
Myovant Sciences GmbHPhase 2
Legorreta Cancer Center at Brown UniversityPhase 1
Brown UniversityPhase 1

See all testosterone clinical trials

Generic filers with tentative approvals for TESTOSTERONE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial30MG/1.5ML ACTUATIONSOLUTION, METERED;TRANSDERMAL
⤷  Try a Trial⤷  Try a Trial750MG/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
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Watson Labs TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 083595-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Ut Inc TESTOSTERONE testosterone GEL;TRANSDERMAL 204570-002 Jul 17, 2020 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 ⤷  Try a Trial ⤷  Try a Trial
Acerus NATESTO testosterone GEL, METERED;NASAL 205488-001 May 28, 2014 ⤷  Try a Trial ⤷  Try a Trial
>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

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