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TRACLEER Drug Profile

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.

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

US Patents:	2
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	73
Clinical Trials:	37
Patent Applications:	2,966
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRACLEER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRACLEER
DailyMed Link:	TRACLEER at DailyMed

Drug patent expirations by year for TRACLEER

Generic Entry Opportunity Date for TRACLEER

Generic Entry Dates for TRACLEER^: ➤ Sign Up* Constraining patent/regulatory exclusivity: ➤ Sign Up NDA: 209279 Dosage: TABLET, FOR SUSPENSION;ORAL
Generic Entry Dates for TRACLEER^: ➤ Sign Up* 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

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Glossary

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

Expired US Patents for TRACLEER

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

International Patents for TRACLEER

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Country	Document Number	Estimated Expiration
South Korea	20100093105	➤ Sign Up
South Korea	20080014002	➤ Sign Up
Australia	2006248593	➤ Sign Up
Slovenia	1883397	➤ Sign Up
New Zealand	564167	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for TRACLEER

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00097	Netherlands	➤ Sign Up	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
C/GB02/030	United Kingdom	➤ Sign Up	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
C0042	France	➤ Sign Up	PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
90017-3	Sweden	➤ Sign Up	PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Summary for TRACLEER

Generic Entry Opportunity Date for TRACLEER

Pharmacology for TRACLEER

Synonyms for TRACLEER

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