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Last Updated: January 24, 2022

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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 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, Mylan Institutional, Padagis Us, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Nexus Pharms, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Clarus, and Endo Pharms Inc, and is included in seventy NDAs. There are fifty-nine patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Testosterone has three hundred and one patent family members in forty-four countries.

There are sixty-nine drug master file entries for testosterone. Twenty suppliers are listed for this compound. There are three 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

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SponsorPhase
University of UtahPhase 2
University of Texas Southwestern Medical CenterPhase 2
Children's Hospital Los AngelesPhase 2

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Generic filers with tentative approvals for TESTOSTERONE
Applicant Application No. Strength Dosage Form
⤷  Sign up for a Free Trial⤷  Sign up for a Free Trial30MG/1.5ML ACTUATIONSOLUTION, METERED;TRANSDERMAL
⤷  Sign up for a Free Trial⤷  Sign up for a Free Trial750MG/3ML (250MG/ML)INJECTABLE;INTRAMUSCULAR
⤷  Sign up for a Free Trial⤷  Sign up for a Free TrialUNKNOWNCAPSULE;ORAL

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 NDA Submissiondate
AXIRON SOLUTION, METERED;TRANSDERMAL testosterone 022504 2013-01-29
FORTESTA GEL, METERED;TRANSDERMAL testosterone 021463 2012-08-14
TESTIM GEL;TRANSDERMAL testosterone 021454 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
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 021015-003 Sep 26, 2003 DISCN Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Actavis Labs Ut Inc TESTOSTERONE testosterone GEL;TRANSDERMAL 204570-002 Jul 17, 2020 AB2 RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Twi Pharms TESTOSTERONE testosterone SOLUTION, METERED;TRANSDERMAL 209836-001 Sep 3, 2021 AT RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Dr Reddys TESTOSTERONE testosterone INJECTABLE;INJECTION 086417-001 Jul 7, 1983 DISCN No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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
Alza TESTODERM TTS testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020791-001 Dec 18, 1997 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Allergan ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Alza TESTODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 019762-001 Oct 12, 1993 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-002 Feb 28, 2000 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Allergan ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for testosterone

Country Patent Number Estimated Expiration
Russian Federation 2331423 ⤷  Sign up for a Free Trial
Hungary 230920 ⤷  Sign up for a Free Trial
World Intellectual Property Organization (WIPO) 2004000263 ⤷  Sign up for a Free Trial
Japan 2012162557 ⤷  Sign up for a Free Trial
New Zealand 524473 ⤷  Sign up for a Free Trial
China 101212975 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

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