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Serving leading biopharmaceutical companies globally:

Baxter
Covington
Express Scripts
Fish and Richardson
Farmers Insurance
Medtronic
Daiichi Sankyo
Citi
US Department of Justice
Teva

Generated: February 22, 2018

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-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 FORTESTA
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 for FORTESTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463-001 Dec 29, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharms FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463-001 Dec 29, 2010 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 FORTESTA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Gel 10 mg/actuation ➤ Subscribe 8/14/2012

Non-Orange Book US Patents for 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
7,157,097 Penetration enhancing and irritation reducing systems ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for FORTESTA

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Julphar
Merck
Fuji
Moodys
Fish and Richardson
Federal Trade Commission
Covington
UBS

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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