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Serving leading biopharmaceutical companies globally:

Express Scripts
Novartis
US Army
McKinsey
Healthtrust
Daiichi Sankyo
Moodys
Federal Trade Commission
Johnson and Johnson
Baxter

Generated: February 20, 2018

DrugPatentWatch Database Preview

ANDROGEL Drug Profile

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When do Androgel patents expire, and what generic 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 forty-eight patent family members in thirty-six countries.

The generic ingredient in ANDROGEL is testosterone. There are sixty-three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for ANDROGEL
Drug patent expirations by year for ANDROGEL
Pharmacology for ANDROGEL
Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for ANDROGEL

US Patents and Regulatory Information for ANDROGEL

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;TRANSDERMAL 021015-002 Feb 28, 2000 AB1 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 AB2 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 AB2 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 AB1 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ANDROGEL
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Gel 1.62% (1.25 g and 2.5 g packets) ➤ Subscribe 6/19/2013
➤ Subscribe Gel 1.62% ➤ Subscribe 4/6/2012
➤ Subscribe Gel Metered-dose Pump 1% ➤ Subscribe 12/19/2008

Non-Orange Book US Patents for 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for ANDROGEL

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Covington
Cipla
Accenture
Dow
Queensland Health
Fish and Richardson
Federal Trade Commission
Daiichi Sankyo

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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