✉ Email this page to a colleague
« Back to Dashboard
▶ Start for $1
Remove trial restrictions
Testosteroneis the generic ingredient in twenty-two 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, Padagis Us, Rising, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Slayback Pharma Llc, Nexus Pharms, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Clarus, Marius Pharms Llc, and Endo Pharms Inc, and is included in seventy-three NDAs. There are seventy-seven 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 eighty-two 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.
Summary for testosterone
|Drug Master File Entries:||69|
|Finished Product Suppliers / Packagers:||21|
|Raw Ingredient (Bulk) Api Vendors:||68|
|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|
|What excipients (inactive ingredients) are in testosterone?||testosterone excipients list|
|DailyMed Link:||testosterone at DailyMed|
Recent Clinical Trials for testosterone
Identify potential brand extensions & 505(b)(2) entrants
|Georgios Papadakis||Phase 3|
|Johns Hopkins Bloomberg School of Public Health||Phase 2|
|University of California, San Diego||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
Paragraph IV (Patent) Challenges for TESTOSTERONE
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Clarus||JATENZO||testosterone undecanoate||CAPSULE;ORAL||206089-001||Mar 27, 2019||RX||Yes||No||See Plans and Pricing||See Plans and Pricing||Y||See Plans and Pricing|
|Auxilium Pharms Llc||TESTIM||testosterone||GEL;TRANSDERMAL||021454-001||Oct 31, 2002||AB2||RX||Yes||Yes||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|Clarus||JATENZO||testosterone undecanoate||CAPSULE;ORAL||206089-003||Mar 27, 2019||RX||Yes||Yes||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|Sandoz Inc||TESTOSTERONE CYPIONATE||testosterone cypionate||INJECTABLE;INJECTION||040615-001||Aug 10, 2006||AO||RX||No||No||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|>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|
|Abbvie||ANDROGEL||testosterone||GEL;TRANSDERMAL||022309-002||Sep 7, 2012||See Plans and Pricing||See Plans and Pricing|
|Endo Pharms||FORTESTA||testosterone||GEL, METERED;TRANSDERMAL||021463-001||Dec 29, 2010||See Plans and Pricing||See Plans and Pricing|
|Alza||TESTODERM||testosterone||FILM, EXTENDED RELEASE;TRANSDERMAL||019762-001||Oct 12, 1993||See Plans and Pricing||See Plans and Pricing|
|Abbvie||ANDROGEL||testosterone||GEL;TRANSDERMAL||022309-003||Sep 7, 2012||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|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.
|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.
|>Company||>Drugname||>Inn||>Product Number / Indication||>Status||>Generic||>Biosimilar||>Orphan||>Marketing Authorisation||>Marketing Refusal|
|Country||Patent Number||Title||Estimated Expiration|
|Mexico||2007015255||METODO Y COMPOSICION PARA ADMINISTRACION TRANSDERMICA DE UN FARMACO. (METHOD AND COMPOSITION FOR TRANSDERMAL DRUG DELIVERY.)||See Plans and Pricing|
|Spain||2589077||See Plans and Pricing|
|Brazil||0312007||Controle de taxa de administração transcutânea usando composições farmacêuticas amorfas||See Plans and Pricing|
|China||102091079||Method and composition for transdermal drug delivery||See Plans and Pricing|
|>Country||>Patent Number||>Title||>Estimated Expiration|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.