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Last Updated: September 26, 2020

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BOSENTAN - Generic Drug Details

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

Bosentan is the generic ingredient in two branded drugs marketed by Actelion Pharms, Alembic Pharms Ltd, Alvogen Pine Brook, Amneal Pharms Co, Cipla, Hikma, Mylan, Natco Pharma Ltd, Par Pharm Inc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Actelion Pharms Ltd, 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. Fourteen suppliers are listed for this compound.

Drug Prices for BOSENTAN

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Recent Clinical Trials for BOSENTAN

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SponsorPhase
University Hospital, RouenPhase 2
Johns Hopkins UniversityPhase 3
National Cancer Institute (NCI)Phase 1

See all BOSENTAN clinical trials

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
Sun Pharm BOSENTAN bosentan TABLET;ORAL 209324-002 Apr 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms BOSENTAN bosentan TABLET;ORAL 207760-001 Apr 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Actelion Pharms TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Actelion Pharms Ltd TRACLEER bosentan TABLET;ORAL 021290-002 Nov 20, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Watson Labs Inc BOSENTAN bosentan TABLET;ORAL 207110-002 Apr 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan BOSENTAN bosentan TABLET;ORAL 205173-001 Jan 15, 2020 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for BOSENTAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526708 C300097 Netherlands   Start 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   Start 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   Start Trial PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
0526708 0290017-3 Sweden   Start 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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