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Last Updated: March 7, 2021

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FORTESTA Drug Profile

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When do Fortesta patents expire, and what generic alternatives are available?

Fortesta is a drug marketed by Endo Pharms and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Fortesta

A generic version of FORTESTA was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.

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Drug patent expirations by year for FORTESTA
Drug Prices for FORTESTA

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Drug Sales Revenue Trends for FORTESTA

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Recent Clinical Trials for FORTESTA

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SponsorPhase
Johns Hopkins UniversityPhase 4
Endo PharmaceuticalsPhase 4
Endo PharmaceuticalsPhase 3

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Pharmacology for FORTESTA
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Paragraph IV (Patent) Challenges for FORTESTA
Tradename Dosage Ingredient NDA Submissiondate
FORTESTA GEL, METERED;TRANSDERMAL testosterone 021463 2012-08-14

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   Start Trial   Start Trial   Start 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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