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Testosteroneis 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.
Summary for testosterone
|Drug Master File Entries:||69|
|Suppliers / Packagers:||16|
|Bulk Api Vendors:||61|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for testosterone|
|Drug Sales Revenues:||Drug sales revenues for testosterone|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for testosterone|
|DailyMed Link:||testosterone at DailyMed|
Recent Clinical Trials for testosterone
Identify potential brand extensions & 505(b)(2) entrants
|North Florida Foundation for Research and Education||Phase 2|
|Brooks Rehabilitation||Phase 2|
|North Florida/South Georgia Veterans Health System||Phase 2|
Generic filers with tentative approvals for TESTOSTERONE
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 Action||Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories 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|
|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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