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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.

This drug has twenty-seven patent family members in twenty-two countries.

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

Summary for TRACLEER

International Patents:	27
US Patents:	2
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	73
Clinical Trials:	37
Patent Applications:	2,910
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRACLEER
DailyMed Link:	TRACLEER at DailyMed

Generic Entry Opportunity Date for TRACLEER

NDA:

209279

Dosage::

TABLET, FOR SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

021290

Dosage::

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TRACLEER

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

Synonyms for TRACLEER

144096-EP2287165A2

144096-EP2287166A2

144096-EP2292620A2

147536-97-8

174227-18-0

212B550

4-?(1,?1-?DIMETHYLETHYL)-?N-?[6-?(2-?HYDROXYETHOXY)-?5-?(2-?METHOXYPHENOXY)[2,?2'-?BIPYRIMIDIN]-?4-?YL]-?BENZENESULFONAMIDE

4-(1,1-Dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl) benzenesulfornamide

4-(1,1-Dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl)benzenesulfornamide

4-(1,1-Dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2''-bipyrimidin)-4-yl) benzenesulfornamide

4-(1,1-dimethylethyl)-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide

4-(tert-butyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidin]-4-yl)benzenesulfonamide

4-(tert-Butyl)-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide

4-t-butyl-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide

4-tert butyl-N-[4-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)pyrimidin-6-yl]benzenesulphonamide

4-tert-Butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2']bipyrimidinyl-4-yl]-benzenesulfonamide

4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidine]-4-yl]benzene-1-sulfonamide

4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]benzenesulfonamide

4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzene-1-sulfonamide

4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide

4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]benzenesulfonamide

4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-ylpyrimidin-4-yl]benzenesulfonamide

4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl]benzenesulfonamide

4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2''-bipyrimidin-4-yl]benzenesulfonamide

4-tert-butyl-N-[6-(2-hydroxyethyloxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]benzenesulfonamide

A808658

AB0018010

AB01275536-01

ABP001094

AC-148

AC1L2XN2

ACN-048487

Actelion

AKOS015852063

AM84442

AN-16081

B5118

BCP9000445

BDBM50061101

Benzenesulfonamide, 4-(1,1-dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)(2,2'-bipyrimidin)-4-yl)-

Bosentan

Bosentan (INN)

Bosentan [USAN:INN:BAN]

bosentan anhydrous

bosentanum

C27H29N5O6S

CAS-147536-97-8

CCG-221182

CHEBI:51450

CHEMBL957

CS-0381

CTK4D4929

D07538

D0U4CE

DB00559

DR003249

DSSTox_CID_26627

DSSTox_GSID_46627

DSSTox_RID_81776

DTXSID7046627

EN002863

FT-0658809

GJPICJJJRGTNOD-UHFFFAOYSA-N

GTPL3494

HE226108

HE312639

HE312640

HMS2090N14

HMS3652F15

HY-A0013

I06-1873

J-008366

K86

KS-5062

L001086

LS-31532

MCULE-3074160312

MolPort-003-845-300

N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]-4-tert-butyl-benzenesulfonamide

NCGC00167440-01

NCGC00167440-02

p-tert-Butyl-N-(6-(2-hydroxyethoxy)-5-(o-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl)benzenesulfonamide

p-tert-Butyl-N-[6-(2-hydroxyethoxy)

PDSP1_001731

PDSP2_001714

PubChem19119

Ro 47-0203

Ro 47-0203/039

Ro-47-0203

Ro-47-0203-029

Ro-47-0203/029

Ro-47-0203/039

Ro-470203029

s4220

SC-19679

SCHEMBL4218

SR-05000001532

SR-05000001532-4

stayveer

TL8001039

Tox21_112444

Tox21_112444_1

Tracleer (TN)

UNII-XUL93R30K2

VA10428

W-5165

XUL93R30K2

Z1541632805

ZINC1538857

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			Y
Actelion Pharms	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes
Actelion Pharms	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes			Y
Actelion Pharms	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes

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Expired US Patents for TRACLEER

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

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International Patents for TRACLEER

Country	Document Number	Estimated Expiration
Slovenia	1883397
South Korea	20080014002
Cyprus	1110610
Brazil	PI0610187

Supplementary Protection Certificates for TRACLEER

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0042	France		PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
00097	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
90017-3	Sweden		PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
C/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