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Last Updated: January 28, 2021

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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, Amneal, Dr Reddys, Lupin, Perrigo Israel, Twi Pharms, Xiromed, Upsher Smith Labs, Auxilium Pharms Llc, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Auxilium Pharms Inc, Eli Lilly And Co, Cipla, Lupin Ltd, Pharmacia And Upjohn, Am Regent, Hikma Farmaceutica, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Wilshire Pharms Inc, Nexus Pharms, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Clarus, and Endo Pharms Inc, and is included in sixty-four NDAs. There are fifty-four patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Testosterone has two hundred and ninety-seven patent family members in forty-four countries.

There are sixty-nine drug master file entries for testosterone. Sixteen 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

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

SponsorPhase
North Florida Foundation for Research and EducationPhase 2
Brooks RehabilitationPhase 2
North Florida/South Georgia Veterans Health SystemPhase 2

See all testosterone clinical trials

Generic filers with tentative approvals for TESTOSTERONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial30MG/1.5ML ACTUATIONSOLUTION, METERED;TRANSDERMAL
  Start Trial  Start Trial750MG/3ML (250MG/ML)INJECTABLE;INTRAMUSCULAR
  Start Trial  Start TrialUNKNOWNUNKNOWN

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 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
Watson Labs TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 086029-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 210362-001 Jun 19, 2018 AO RX No No   Start Trial   Start Trial   Start Trial
Wilshire Pharms Inc TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 206368-001 Apr 24, 2019 AO RX No No   Start Trial   Start Trial   Start 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
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010   Start Trial   Start Trial
Alza TESTODERM TTS testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020791-001 Dec 18, 1997   Start Trial   Start Trial
Allergan ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.