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Last Updated: May 25, 2022

TRACLEER Drug Patent 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. Nine 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 HIKMA on April 26th, 2019.

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Drug patent expirations by year for TRACLEER
Drug Prices for TRACLEER

See drug prices for TRACLEER

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
University of Mississippi Medical CenterEarly Phase 1

See all TRACLEER clinical trials

Paragraph IV (Patent) Challenges for TRACLEER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRACLEER for Oral Suspension bosentan 32 mg 209279 1 2019-02-08

US Patents and Regulatory Information for TRACLEER

TRACLEER is protected by two US patents and two FDA Regulatory Exclusivities.

Patents protecting TRACLEER

Dispersible bosentan tablet
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dispersible bosentan tablet
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting TRACLEER

TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) IN PEDIATRIC PATIENTS AGED 3 YRS AND OLDER WITH IDIOPATHIC OR CONGENITAL PAH TO IMPROVE PULMONARY VASCULAR RESISTANCE (PVR), WHICH IS EXPECTED TO RESULT IN AN IMPROVEMENT IN EXERCISE ABILITY
Exclusivity Expiration: See Plans and Pricing

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion TRACLEER bosentan TABLET;ORAL 021290-001 Nov 20, 2001 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion TRACLEER bosentan TABLET;ORAL 021290-002 Nov 20, 2001 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for TRACLEER

When does loss-of-exclusivity occur for TRACLEER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06248593
Estimated Expiration: See Plans and Pricing

Austria

Patent: 1914
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0610187
Estimated Expiration: See Plans and Pricing

Canada

Patent: 07098
Estimated Expiration: See Plans and Pricing

China

Patent: 1175484
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 10610
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 83397
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 83397
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2006011150
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 20212
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7383
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19399
Estimated Expiration: See Plans and Pricing

Patent: 08540512
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07014454
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4167
Estimated Expiration: See Plans and Pricing

Norway

Patent: 9781
Estimated Expiration: See Plans and Pricing

Patent: 076325
Estimated Expiration: See Plans and Pricing

Poland

Patent: 83397
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 83397
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 04774
Estimated Expiration: See Plans and Pricing

Patent: 07146395
Estimated Expiration: See Plans and Pricing

Patent: 10129460
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 83397
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0710903
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 080014002
Estimated Expiration: See Plans and Pricing

Patent: 100093105
Estimated Expiration: See Plans and Pricing

Spain

Patent: 36943
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRACLEER around the world.

Country Patent Number Title Estimated Expiration
Denmark 1883397 See Plans and Pricing
Cyprus 2306 Sulfonamide, preparation and use thereof as medicine and intermediate. See Plans and Pricing
Portugal 1883397 See Plans and Pricing
Greece 3035162 See Plans and Pricing
Yugoslavia 61492 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRACLEER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526708 0290017-3 Sweden See Plans and Pricing PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
0526708 300097 Netherlands See Plans and Pricing
0526708 CA 2002 00026 Denmark See Plans and Pricing
0526708 C300097 Netherlands See Plans and Pricing 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 02C0042 France See Plans and Pricing 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
AstraZeneca
McKinsey
Colorcon
Baxter

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.