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Last Updated: May 24, 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 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. Twenty-one 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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Drug patent expirations by year for FORTESTA
Drug Prices for FORTESTA

See drug prices for FORTESTA

Drug Sales Revenue Trends for FORTESTA

See drug sales revenues for FORTESTA

Recent Clinical Trials for FORTESTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Endo PharmaceuticalsPhase 4
Johns Hopkins UniversityPhase 4
Endo PharmaceuticalsPhase 3

See all FORTESTA clinical trials

Pharmacology for FORTESTA
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
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 Pharms 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Withdrawn no no no 2006-07-28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 Chilcott  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

International Patents for FORTESTA

See the table below for patents covering FORTESTA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1030668 ⤷  Sign Up
Brazil 9814014 Composição para aplicação tópica tendo propriedades de melhora da penetração ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9924041 ⤷  Sign Up
Portugal 1510213 ⤷  Sign Up
European Patent Office 1510213 Systèmes comprenant de la testostérone améliorants la pénétration et reduisants les irritations (Penetration enhancing and irritation reducing systems comprising testosterone) ⤷  Sign Up
Australia 747041 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.