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Last Updated: May 6, 2021

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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 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.

DrugPatentWatch® 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
University of Mississippi Medical CenterEarly Phase 1
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 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 TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Actelion TRACLEER bosentan TABLET;ORAL 021290-001 Nov 20, 2001 AB RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Actelion TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Actelion TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Actelion TRACLEER bosentan TABLET;ORAL 021290-002 Nov 20, 2001 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>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   Get Started for $10 PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
0526708 CA 2002 00026 Denmark   Get Started for $10
0526708 300097 Netherlands   Get Started for $10
0526708 02C0042 France   Get Started for $10 PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
0526708 C300097 Netherlands   Get Started for $10 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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