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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 26^th, 2020.

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Summary for TRACLEER

International Patents:	28
US Patents:	2
Applicants:	2
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	84
Clinical Trials:	39
Patent Applications:	3,375
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

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
Geropharm	Phase 1

See all TRACLEER clinical trials

Recent Litigation for TRACLEER

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ACTELION PHARMACEUTICALS LTD. v. ZYDUS PHARMACEUTICALS (USA), INC.	2019-12-31
ACTELION PHARMACEUTICALS LTD. v. NATCO PHARMA LIMITED	2019-05-28

See all TRACLEER litigation

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) 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

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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	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

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

International Patents for TRACLEER

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Country	Patent Number	Estimated Expiration
Japan	2008540512	Start Trial
South Africa	200710903	Start Trial
Poland	1883397	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for TRACLEER

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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