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Last Updated: November 21, 2024

FORTESTA Drug Patent Profile


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

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

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

DrugPatentWatch® 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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  • What is the 5 year forecast for FORTESTA?
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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
Endo PharmaceuticalsPhase 4
Johns Hopkins UniversityPhase 4
Endo PharmaceuticalsPhase 3

See all FORTESTA clinical trials

Paragraph IV (Patent) Challenges for FORTESTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FORTESTA Gel testosterone 10 mg/actuation 021463 1 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 Operations FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463-001 Dec 29, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for FORTESTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Warner Chilcott UK Ltd. Intrinsa testosterone EMEA/H/C/000634
Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Withdrawn no no no 2006-07-28
Warner ChilcottĀ  Deutschland GmbH Livensa testosterone EMEA/H/C/000630
Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Withdrawn no no no 2006-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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