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ANDROGEL Drug Profile

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

This drug has one hundred and thirty-three 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. Nineteen suppliers are listed for this compound. There are two tentative approvals 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 list4
Drug Prices: :see details

Pharmacology for Tradename: ANDROGEL

Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL021015-002Feb 28, 2000RXYes9,132,089*PED► subscribeY► subscribe
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-003Sep 7, 2012RXYes9,132,089*PED► subscribeY► subscribe
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-003Sep 7, 2012RXYes8,466,136► subscribeY ► 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
New Zealand535368► subscribe
Japan5728508► subscribe
South Africa200301705► 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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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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