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Last Updated: April 22, 2024

Bosentan - Generic Drug Details


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What are the generic drug sources for bosentan and what is the scope of freedom to operate?

Bosentan is the generic ingredient in two branded drugs marketed by Actelion, Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Hikma, Mylan, Natco Pharma Ltd, Par Pharm Inc, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bosentan has twenty-eight patent family members in twenty-three countries.

There are nineteen drug master file entries for bosentan. Six suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for bosentan

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Recent Clinical Trials for bosentan

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

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

See all bosentan clinical trials

Generic filers with tentative approvals for BOSENTAN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial125MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial62.5MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial32MGTABLET, FOR SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Actelion TRACLEER bosentan TABLET;ORAL 021290-002 Nov 20, 2001 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Co BOSENTAN bosentan TABLET;ORAL 209742-002 Apr 26, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan BOSENTAN bosentan TABLET;ORAL 205173-001 Jan 15, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc BOSENTAN bosentan TABLET;ORAL 207110-002 Apr 26, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alembic BOSENTAN bosentan TABLET;ORAL 211461-002 Jan 23, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Molecular BOSENTAN bosentan TABLET;ORAL 210342-002 Jan 3, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

International Patents for bosentan

Country Patent Number Title Estimated Expiration
Poland 1883397 ⤷  Try a Trial
China 101175484 Dispersible bosertan tablet ⤷  Try a Trial
European Patent Office 1883397 COMPRIME DISPERSIBLE (DISPERSIBLE BOSERTAN TABLET) ⤷  Try a Trial
Mexico 2007014454 TABLETA DE BOSENTAN DISPERSABLE. (DISPERSIBLE BOSERTAN TABLET.) ⤷  Try a Trial
Austria E451914 ⤷  Try a Trial
Cyprus 1110610 ⤷  Try a Trial
Denmark 1883397 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bosentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526708 SPC/GB02/030 United Kingdom ⤷  Try a Trial PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
0526708 C300097 Netherlands ⤷  Try a Trial PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
0526708 02C0042 France ⤷  Try a Trial PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
0526708 0290017-3 Sweden ⤷  Try a Trial PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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