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Generated: April 29, 2017

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Testosterone - Generic Drug Details

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What are the generic sources for testosterone and what is the scope of freedom to operate?

is the generic ingredient in eighteen branded drugs marketed by Eli Lilly And Co, Abbvie, Auxilium Pharms Inc, Watson Labs, Actavis Labs Ut Inc, Par Pharm, Auxilium Pharms, Perrigo Israel, Alza, Endo Pharms, Ani Pharms Inc, Aytu Bioscience Inc, Allergan Sales Llc, Upsher-smith Labs, Sandoz Inc, Sun Pharm Inds Ltd, Paddock Llc, Watson Pharms Inc, Pharmacia And Upjohn, Hikma Farmaceutica, Mylan Institutional, West-ward Pharms Int, Bel Mar, Lilly, Elkins Sinn, and Endo Pharms Inc, and is included in forty-eight NDAs. There are forty-six 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 eighty patent family members in forty-six countries.

There are sixty-one drug master file entries for testosterone. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: testosterone

Drug Master File Entries: see list61
Suppliers / Packagers: see list18
Bulk Api Vendors: see list52
Clinical Trials: see list294
Patent Applications: see list9,898
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:testosterone at DailyMed

Pharmacology for Ingredient: testosterone

Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists

Tentative approvals for TESTOSTERONE

Applicant Application No. Form Dosage
► Subscribe► SubscribeSOLUTION;TOPICAL30MG/1.5ML
► Subscribe► SubscribeSOLUTION;TOPICAL30MG/1.5ML
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010ATRXYesYes6,299,900► SubscribeY ► Subscribe
Eli Lilly And Co
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010ATRXYesYes6,923,983► SubscribeY ► Subscribe
GEL;TRANSDERMAL021015-001Feb 28, 2000AB1RXYesNo9,132,089*PED► SubscribeY► Subscribe
Endo Pharms
testosterone enanthate
INJECTABLE;INJECTION009165-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
GEL, METERED;TRANSDERMAL022309-001Apr 29, 2011ABRXYesYes8,754,070► SubscribeY ► Subscribe
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