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Last Updated: January 26, 2020

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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 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. Eleven suppliers are listed for this compound. Additional details are available on the bosentan profile page.

US ANDA Litigation and Generic Entry Outlook for Tracleer

A generic version of TRACLEER was approved as bosentan by AMNEAL PHARMS CO on January 26th, 2020.

  Start Trial

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
City of Hope Medical CenterPhase 1
National Cancer Institute (NCI)Phase 1
GeropharmPhase 1

See all TRACLEER clinical trials

Recent Litigation for TRACLEER

Identify potential future generic entrants

District Court Litigation
Case NameDate
ACTELION PHARMACEUTICALS LTD. v. ZYDUS PHARMACEUTICALS (USA), INC.2019-12-31
ACTELION PHARMACEUTICALS LTD. v. NATCO PHARMA LIMITED2019-05-28

See all TRACLEER litigation

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) 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-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide
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
BCP05202
BCP9000445
BDBM50061101
Benzenesulfonamide, 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]-
Bosentan
Bosentan (INN)
Bosentan [USAN:INN:BAN]
bosentanum
C27H29N5O6S
CAS-147536-97-8
CCG-221182
CHEBI:51450
CHEMBL957
CS-0381
CTK4D4929
D07538
DB00559
DSSTox_CID_26627
DSSTox_GSID_46627
DSSTox_RID_81776
DTXSID7046627
EN002863
FT-0658809
GJPICJJJRGTNOD-UHFFFAOYSA-N
GTPL3494
HMS2090N14
HMS3652F15
HMS3715N05
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
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
SB17356
SC-19679
SCHEMBL4218
SR-05000001532
SR-05000001532-1
SR-05000001532-2
SR-05000001532-4
SW199648-3
TL8001039
Tox21_112444
Tox21_112444_1
UNII-XUL93R30K2
VA10428
W-5165
XUL93R30K2
Z1541632805
ZINC1538857
Paragraph IV (Patent) Challenges for TRACLEER
Tradename Dosage Ingredient NDA Submissiondate
TRACLEER TABLET, FOR SUSPENSION;ORAL bosentan 209279 2019-02-08

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   Start Trial   Start Trial Y   Start Trial
Actelion Pharms TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Actelion Pharms TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TRACLEER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526708 0290017-3 Sweden   Start Trial PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
0526708 SPC/GB02/030 United Kingdom   Start Trial 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 02C0042 France   Start Trial 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

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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
AstraZeneca
Johnson and Johnson
Boehringer Ingelheim
Express Scripts

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