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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Baxter
Chubb
Harvard Business School
Dow
US Army
Boehringer Ingelheim
Fish and Richardson
QuintilesIMS

Generated: July 19, 2018

DrugPatentWatch Database Preview

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.
Drug patent expirations by year for TRACLEER
Generic Entry Opportunity Date for TRACLEER
Generic Entry Dates for TRACLEER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
TABLET, FOR SUSPENSION;ORAL
Generic Entry Dates for TRACLEER*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
NDA:
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.

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 ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for TRACLEER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0042 France ➤ Sign Up PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Cipla
Covington
US Army
Cerilliant
AstraZeneca
Chinese Patent Office
Cantor Fitzgerald
Fuji

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