TRACLEER Drug Patent Profile

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. Six 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 SUN PHARM on April 26^th, 2019.

Summary for TRACLEER

International Patents:	28
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	43
Patent Applications:	4,619
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRACLEER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRACLEER
What excipients (inactive ingredients) are in TRACLEER?	TRACLEER excipients list
DailyMed Link:	TRACLEER at DailyMed

See drug prices for TRACLEER

Recent Clinical Trials for TRACLEER

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
University of Mississippi Medical Center	Early Phase 1

See all TRACLEER clinical trials

Pharmacology for TRACLEER

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for TRACLEER

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

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

FDA Regulatory Exclusivity protecting 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			Y
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001	AB	RX	Yes	No
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes			Y
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001	AB	RX	Yes	Yes

Expired US Patents for TRACLEER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001

EU/EMA Drug Approvals for TRACLEER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Tracleer	bosentan	EMEA/H/C/000401 Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in:, , , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology., , , Some improvements have also been shown in patients with PAH WHO functional class II., , Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.,	Authorised	no	no	no	2002-05-14

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

Austria

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Germany

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

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
Japan	2008540512
Denmark	1883397
New Zealand	564167	Dispersible tablet comprising 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-benzenesulfonamide (bosutan)
World Intellectual Property Organization (WIPO)	2006123285
European Patent Office	0526708	Sulfonamide, sa préparation et son usage comme médicament et intermédiaire (Sulfonamide, preparation and use thereof as medicine and intermediate)
Portugal	1883397

Supplementary Protection Certificates for TRACLEER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0526708	SPC/GB02/030	United Kingdom		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	C300097	Netherlands		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	0290017-3	Sweden		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
0526708	02C0042	France		PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
0526708	300097	Netherlands