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Serving leading biopharmaceutical companies globally:

UBS
Novartis
Dow
Accenture
US Department of Justice
McKesson
Daiichi Sankyo
Cantor Fitzgerald
US Army
Farmers Insurance

Generated: December 13, 2017

DrugPatentWatch Database Preview

FORTESTA Drug Profile

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When do Fortesta patents expire, and when can generic versions of Fortesta launch?

Fortesta is a drug marketed by Endo Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in sixteen countries.

The generic ingredient in FORTESTA is testosterone. There are sixty-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Drug patent expirations by year for FORTESTA

Pharmacology for FORTESTA

Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for FORTESTA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Endo PharmsFORTESTAtestosteroneGEL, METERED;TRANSDERMAL021463-001Dec 29, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Endo PharmsFORTESTAtestosteroneGEL, METERED;TRANSDERMAL021463-001Dec 29, 2010ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for FORTESTA

Drugname Dosage Strength RLD Submissiondate
testosteroneGel10 mg/actuationFortesta8/14/2012

Non-Orange Book Patents for Tradename: FORTESTA

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
7,157,097Penetration enhancing and irritation reducing systems► 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: FORTESTA

Country Document Number Estimated Expiration
Hong Kong1074788► Subscribe
Portugal1510213► Subscribe
Canada2309688► Subscribe
World Intellectual Property Organization (WIPO)9924041► Subscribe
Brazil9814014► Subscribe
Denmark1510213► Subscribe
European Patent Office1030668► Subscribe
European Patent Office1510213► Subscribe
Norway20002422► Subscribe
Australia1313299► 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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Serving leading biopharmaceutical companies globally:

Queensland Health
UBS
Harvard Business School
Novartis
Julphar
Cerilliant
McKesson
US Department of Justice
Boehringer Ingelheim
McKinsey

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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