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Last Updated: March 3, 2021

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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 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

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

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 209324-001 Apr 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc BOSENTAN bosentan TABLET;ORAL 205699-002 Apr 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd BOSENTAN bosentan TABLET;ORAL 206987-001 Apr 26, 2019 AB RX 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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Express Scripts
Baxter
Merck
McKinsey

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