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Serving leading biopharmaceutical companies globally:

McKinsey
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Novartis
Daiichi Sankyo
Boehringer Ingelheim
Chinese Patent Office
Express Scripts
Cantor Fitzgerald
US Army
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Testosterone - Generic Drug Details

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

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, Auxilium Pharms Llc, Par Pharm, Perrigo Israel, Alza, Endo Pharms, Ani Pharms Inc, Perrigo Uk Finco, Aytu Bioscience Inc, Allergan Sales Llc, Upsher-smith Labs, Sandoz Inc, Sun Pharm Inds Ltd, Paddock Llc, Watson Pharms Inc, Pharmacia And Upjohn, Luitpold Pharms Inc, Hikma Farmaceutica, Mylan Institutional, West-ward Pharms Int, Bel Mar, Lilly, Elkins Sinn, and Endo Pharms Inc, and is included in fifty-two 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 four hundred and fourteen patent family members in forty-seven countries and nine supplementary protection certificates in three countries.

There are sixty-two drug master file entries for testosterone. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: testosterone

US Patents:46
Tradenames:18
Applicants:28
NDAs:52
Drug Master File Entries: see list62
Suppliers / Packagers: see list17
Bulk Api Vendors: see list52
Clinical Trials: see list747
Patent Applications: see list9,911
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. Strength Dosage Form
u► Subscribe30MG/1.5MLSOLUTION;TOPICAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-003Sep 7, 2012AB2RXYesYes► Subscribe► Subscribe ► Subscribe
Abbvie
ANDROGEL
testosterone
GEL, METERED;TRANSDERMAL022309-001Apr 29, 2011ABRXYesYes► Subscribe► SubscribeY► Subscribe
Elkins Sinn
TESTOSTERONE PROPIONATE
testosterone propionate
INJECTABLE;INJECTION080276-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Aytu Bioscience Inc
NATESTO
testosterone
GEL, METERED;NASAL205488-001May 28, 2014RXNoNo► Subscribe► SubscribeY ► Subscribe
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-002Sep 7, 2012AB2RXYesNo► Subscribe► Subscribe ► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010DISCNYesNo► Subscribe► Subscribe ► Subscribe
Pharmacia And Upjohn
DEPO-TESTOSTERONE
testosterone cypionate
INJECTABLE;INJECTION085635-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Ani Pharms Inc
TESTOSTERONE
testosterone
GEL;TRANSDERMAL202763-002Feb 14, 2012BXRXNoNo► Subscribe► Subscribe► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Pharmacia And Upjohn
DEPO-TESTOSTERONE
testosterone cypionate
INJECTABLE;INJECTION085635-003Approved Prior to Jan 1, 1982AORXNoYes► Subscribe► Subscribe► 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;TRANSDERMAL020489-001Sep 29, 1995► Subscribe► Subscribe
Allergan Sales Llc
ANDRODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL020489-002May 2, 1997► Subscribe► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010► Subscribe► Subscribe
Allergan Sales Llc
ANDRODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL020489-002May 2, 1997► Subscribe► Subscribe
Allergan Sales Llc
ANDRODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL020489-001Sep 29, 1995► Subscribe► Subscribe
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-002Oct 12, 1993► Subscribe► Subscribe
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-001Oct 12, 1993► Subscribe► Subscribe
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-001Oct 12, 1993► Subscribe► Subscribe
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-001Oct 12, 1993► Subscribe► Subscribe
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-002Oct 12, 1993► Subscribe► 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
8,357,393Transdermal delivery rate control using amorphous pharmaceutical compositions► Subscribe
8,177,449Spreading implement► Subscribe
9,238,072Controlled release delivery system for nasal applications and method of treatment► Subscribe
8,765,177Bioadhesive progressive hydration tablets► Subscribe
6,699,494 Pharmaceutical composition and method for treating premature labor► Subscribe
6,624,200 Bioadhesive progressive hydration tablets► Subscribe
7,094,422Topical delivery of antifungal agents► Subscribe
6,126,959 Pharmaceutical composition for treating dysmenorrhea and premature labor► Subscribe
6,964,777 Transdermal delivery of antianxiety agents► Subscribe
2,004,092,494► 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
Japan2005047932► Subscribe
Argentina039644► Subscribe
European Patent Office2283865► Subscribe
Japan2008542306► Subscribe
China1186009► Subscribe
Brazil9814014► Subscribe
European Patent Office1322336► Subscribe
Denmark1425019► Subscribe
Japan2005519985► Subscribe
Egypt24882► 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
973Luxembourg► Subscribe91973, EXPIRES: 20220219
971Luxembourg► Subscribe91971, EXPIRES: 20220219
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2012 00010Denmark► Subscribe
2012 00011Denmark► Subscribe
972Luxembourg► Subscribe91972, EXPIRES: 20220219
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
US Army
Express Scripts
Chinese Patent Office
Moodys
Johnson and Johnson
Queensland Health
Fuji
US Department of Justice
Harvard Business School

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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