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Last Updated: January 28, 2022

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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 Pharms Ltd, Alvogen Pine Brook, Amneal Pharms Co, Cipla, 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. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for bosentan

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Recent Clinical Trials for bosentan

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SponsorPhase
Johns Hopkins UniversityPhase 3
Brooke Army Medical CenterPhase 3
Ottawa Hospital Research InstitutePhase 3

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Generic filers with tentative approvals for BOSENTAN
Applicant Application No. Strength Dosage Form
⤷  Sign up for a Free Trial⤷  Sign up for a Free 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 NDA Submissiondate
TRACLEER TABLET, FOR SUSPENSION;ORAL bosentan 209279 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
Par Pharm Inc BOSENTAN bosentan TABLET;ORAL 205699-002 Apr 26, 2019 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Alembic Pharms Ltd BOSENTAN bosentan TABLET;ORAL 211461-002 Jan 23, 2020 DISCN No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Actelion TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Actelion TRACLEER bosentan TABLET;ORAL 021290-002 Nov 20, 2001 AB RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for bosentan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion TRACLEER bosentan TABLET;ORAL 021290-001 Nov 20, 2001 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Actelion TRACLEER bosentan TABLET;ORAL 021290-002 Nov 20, 2001 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for bosentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526708 0290017-3 Sweden ⤷  Sign up for a Free Trial PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
0526708 C300097 Netherlands ⤷  Sign up for a Free 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 SPC/GB02/030 United Kingdom ⤷  Sign up for a Free 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 02C0042 France ⤷  Sign up for a Free Trial PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.