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Last Updated: August 14, 2020

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TRACLEER Drug Profile

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When do Tracleer patents expire, and when can generic versions of Tracleer launch?

Tracleer is a drug marketed by Actelion Pharms and Actelion Pharms Ltd and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in twenty-three countries.

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

US ANDA Litigation and Generic Entry Outlook for Tracleer

A generic version of TRACLEER was approved as bosentan by AMNEAL PHARMS CO on April 26th, 2019.

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Drug patent expirations by year for TRACLEER
Drug Prices for TRACLEER

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Recent Clinical Trials for TRACLEER

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 1
GeropharmPhase 1

See all TRACLEER clinical trials

Paragraph IV (Patent) Challenges for TRACLEER
Tradename Dosage Ingredient NDA Submissiondate
TRACLEER TABLET, FOR SUSPENSION;ORAL bosentan 209279 2019-02-08

US Patents and Regulatory Information for TRACLEER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes   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
>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 TRACLEER

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 300097 Netherlands   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
AstraZeneca
McKinsey
Colorcon
Baxter

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