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Last Updated: November 12, 2019

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Bosentan - Generic Drug Details

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What are the generic drug sources for bosentan and what is the scope of freedom to operate?

Bosentan is the generic ingredient in two branded drugs marketed by Actelion Pharms, Alvogen Pine Brook, Amneal Pharms Co, Natco Pharma Ltd, Par Pharm Inc, Sun Pharm, Watson Labs Inc, West-ward Pharms Int, Zydus Pharms, and Actelion Pharms Ltd, and is included in ten NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bosentan has twenty-seven patent family members in twenty-two countries.

There are nineteen drug master file entries for bosentan. Eleven suppliers are listed for this compound.

Summary for bosentan

International Patents:	27
US Patents:	2
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	19
Suppliers / Packagers:	11
Bulk Api Vendors:	83
Clinical Trials:	120
Patent Applications:	5,417
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bosentan
DailyMed Link:	bosentan at DailyMed

Recent Clinical Trials for bosentan

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins University	Phase 3
Retinset SL	Phase 1
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA	Phase 1

See all bosentan clinical trials

Recent Litigation for bosentan

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ACTELION PHARMACEUTICALS LTD. v. NATCO PHARMA LIMITED	2019-05-28

See all bosentan litigation

Pharmacology for bosentan

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

Synonyms for bosentan

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 (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
Tracleer
UNII-XUL93R30K2
VA10428
W-5165
XUL93R30K2
Z1541632805
ZINC1538857

Paragraph IV (Patent) Challenges for BOSENTAN

Tradename	Dosage	Ingredient	NDA	Submissiondate
TRACLEER	TABLET, FOR SUSPENSION;ORAL	bosentan	209279	2019-02-08

US Patents and Regulatory Information for bosentan

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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
Natco Pharma Ltd	BOSENTAN	bosentan	TABLET;ORAL	206987-001	Apr 26, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Par Pharm Inc	BOSENTAN	bosentan	TABLET;ORAL	205699-001	Apr 26, 2019	AB	RX	No	No	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				Start Trial
Watson Labs Inc	BOSENTAN	bosentan	TABLET;ORAL	207110-001	Apr 26, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Actelion Pharms Ltd	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Sun Pharm	BOSENTAN	bosentan	TABLET;ORAL	209324-002	Apr 26, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Par Pharm Inc	BOSENTAN	bosentan	TABLET;ORAL	205699-002	Apr 26, 2019	AB	RX	No	No	Start Trial	Start Trial				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 bosentan

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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 bosentan

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Country	Patent Number	Estimated Expiration
Cyprus	1110610	Start Trial
Denmark	1883397	Start Trial
Hong Kong	1120212	Start Trial
Mexico	2007014454	Start Trial
World Intellectual Property Organization (WIPO)	2006123285	Start Trial
Spain	2336943	Start Trial
European Patent Office	1883397	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for bosentan

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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	C300097	Netherlands	Start Trial	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
0526708	02C0042	France	Start Trial	PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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