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Testosterone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for testosterone?

Testosterone 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, 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-five patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient 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

Tradenames:18
Patents:46
Applicants:26
NDAs:48
Drug Master File Entries: see list61
Suppliers / Packagers: see list18
Bulk Api Vendors: see list52
Clinical Trials: see list294
Patent Applications: see list9,832
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

Ingredient-typeAndrostanes
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo Israel
TESTOSTERONE
testosterone
GEL;TRANSDERMAL203098-003Jan 31, 2013RXNoNo► Subscribe► Subscribe
Auxilium Pharms
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 2002RXYesYes7,320,968► Subscribe ► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010RXYesYes8,419,307► Subscribe ► Subscribe
Auxilium Pharms
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 2002RXYesYes7,608,609► Subscribe ► Subscribe
Abbvie
ANDROGEL
testosterone
GEL, METERED;TRANSDERMAL021015-003Sep 26, 2003RXYesYes9,132,089*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: testosterone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
ANDRODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL020489-002May 2, 19974,855,294► Subscribe
Allergan Sales Llc
ANDRODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL020489-001Sep 29, 19954,983,395► Subscribe
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-001Oct 12, 19934,704,282► Subscribe
Allergan Sales Llc
ANDRODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL020489-001Sep 29, 19954,855,294► Subscribe
Allergan Sales Llc
ANDRODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL020489-001Sep 29, 19955,152,997► Subscribe
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Non-Orange Book Patents for Generic Ingredient: testosterone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,126,959 Pharmaceutical composition for treating dysmenorrhea and premature labor► Subscribe
6,916,487 Transdermal delivery of antiemetics► Subscribe
8,765,177Bioadhesive progressive hydration tablets► Subscribe
6,964,777 Transdermal delivery of antianxiety agents► Subscribe
6,916,486 Transdermal delivery of analgesics► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: testosterone

Country Document Number Estimated Expiration
Japan2001522804► Subscribe
Australia5258999► Subscribe
Australia2001286995► Subscribe
European Patent Office1511494► Subscribe
Norway20010919► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TESTOSTERONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00012Denmark► Subscribe
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
973Luxembourg► Subscribe91973, EXPIRES: 20220219
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
972Luxembourg► Subscribe91972, EXPIRES: 20220219
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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 verifification 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.

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