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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
McKinsey
Chinese Patent Office
Julphar
Daiichi Sankyo
Merck
Express Scripts
Novartis
US Army
Baxter

Generated: July 28, 2017

DrugPatentWatch Database Preview

ANDROGEL Drug Profile

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What is the patent landscape for Androgel, and what generic Androgel alternatives are available?

Androgel is a drug marketed by Abbvie and is included in two NDAs. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and thirty-six patent family members in thirty-five countries.

The generic ingredient in ANDROGEL is testosterone. There are sixty-one drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

Summary for Tradename: ANDROGEL

Patents:11
Applicants:1
NDAs:2
Suppliers / Packagers: see list3
Bulk Api Vendors: see list52
Clinical Trials: see list34
Patent Applications: see list9,772
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ANDROGEL at DailyMed

Pharmacology for Tradename: ANDROGEL

Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
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;TRANSDERMAL021015-002Feb 28, 2000AB1RXYesYes► Subscribe► SubscribeY► Subscribe
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-003Sep 7, 2012AB2RXYesYes► Subscribe► SubscribeY► Subscribe
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-003Sep 7, 2012AB2RXYesYes► Subscribe► Subscribe ► Subscribe
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-003Sep 7, 2012AB2RXYesYes► Subscribe► SubscribeY► Subscribe
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-003Sep 7, 2012AB2RXYesYes► Subscribe► Subscribe ► Subscribe
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Paragraph IV activity for: ANDROGEL

Drugname Dosage Strength RLD Submissiondate
testosteroneGel1.62% (1.25 g and 2.5 g packets)Androgel6/19/2013
testosteroneGel1.62%Androgel4/6/2012
testosteroneGel Metered-dose Pump1%Androgel12/19/2008

Non-Orange Book Patents for Tradename: ANDROGEL

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
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 Tradename: ANDROGEL

Country Document Number Estimated Expiration
Canada2624788► Subscribe
Morocco29941► Subscribe
World Intellectual Property Organization (WIPO)0217967► Subscribe
Georgia, Republic ofP20125432► Subscribe
World Intellectual Property Organization (WIPO)2007044976► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Federal Trade Commission
Healthtrust
Julphar
Cantor Fitzgerald
Queensland Health
Teva
Daiichi Sankyo
McKesson

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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