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Last Updated: November 2, 2024

BOSENTAN Drug Patent Profile


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

Bosentan is a drug marketed by Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Endo Operations, Hikma, Mylan, Natco Pharma Ltd, Sun Pharm, Watson Labs Inc, and Zydus Pharms. and is included in eleven NDAs.

The generic ingredient in BOSENTAN is bosentan. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bosentan profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bosentan

A generic version of BOSENTAN was approved as bosentan by SUN PHARM on April 26th, 2019.

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Drug patent expirations by year for BOSENTAN
Drug Prices for BOSENTAN

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Recent Clinical Trials for BOSENTAN

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SponsorPhase
PPDPhase 1
CTI BioPharmaPhase 1
Jean-Pierre RoutyN/A

See all BOSENTAN clinical trials

Paragraph IV (Patent) Challenges for BOSENTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRACLEER for Oral Suspension bosentan 32 mg 209279 1 2019-02-08

US Patents and Regulatory Information for BOSENTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic BOSENTAN bosentan TABLET;ORAL 211461-001 Jan 23, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm BOSENTAN bosentan TABLET;ORAL 209324-002 Apr 26, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Molecular BOSENTAN bosentan TABLET;ORAL 210342-001 Jan 3, 2020 DISCN No 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 BOSENTAN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V.   Tracleer bosentan EMEA/H/C/000401
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in:, , , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology., , , Some improvements have also been shown in patients with PAH WHO functional class II., , Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.,
Authorised no no no 2002-05-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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