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OPSUMIT Drug Profile

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When do Opsumit patents expire, and when can generic versions of Opsumit launch?

Opsumit is a drug marketed by Actelion Pharms Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-two patent family members in thirty-one countries.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.

Summary for OPSUMIT

International Patents:	92
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	60
Clinical Trials:	7
Patent Applications:	33
Drug Prices:	Drug price information for OPSUMIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OPSUMIT
Prior Art and Litigation Support	Order Prior Art and Litigation support for OPSUMIT
DailyMed Link:	OPSUMIT at DailyMed

Generic Entry Opportunity Date for OPSUMIT

NDA:

204410

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 OPSUMIT

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Synonyms for OPSUMIT

(non-labelled)Macitentan-d7

441798-33-0

5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine

AB0007893

ABP001066

AC-30102

ACN-034475

ACT 064992

ACT 064992; ACT-064992

ACT-064992

ACT064992

Actelion-1

AKOS024463406

AM81244

AOB87765

BC600464

BCP05309

BDBM50395626

C19H20Br2N6O4S

cas:441798-33-0;Macitentan

CHEBI:76607

CHEMBL2103873

CS-0686

D10135

DB08932

DTXSID50196063

EX-A544

FT-0696675

GTPL7352

HMS3653N06

HY-14184

JGCMEBMXRHSZKX-UHFFFAOYSA-N

KS-000005UM

Macitentan

Macitentan (Actelion-1,ACT-064992)

Macitentan (JAN/USAN)

Macitentan [USAN:INN]

macitentanum

MLS006011174

MolPort-023-299-418

N-(5-(4-Bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-N'-propylsulfamide

N-(5-(4-Bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxy)ethoxy)pyrimidin-4-yl)-N'-propylsulfamide

n-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propyl-sulfamide

N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide

N-[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-N'-propylsulfuric diamide

NCGC00346456-01

Opsumit (TN)

QC-10426

S-7749

s8051

SB14841

SCHEMBL1445625

SMR004702943

ST24048423

Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl-

SW219473-1

UNII-Z9K9Y9WMVL

X6162

Z9K9Y9WMVL

ZINC43202140

ZLA0005

zlchem 5

US Patents and Regulatory Information for OPSUMIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actelion Pharms Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes
Actelion Pharms Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y	Y
Actelion Pharms Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y
Actelion Pharms Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y
Actelion Pharms Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes

Paragraph IV (Patent) Challenges for OPSUMIT

Drugname	Dosage	Strength	RLD	Date
	Tablets	10 mg

International Patents for OPSUMIT

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008026156
Japan	5054061
Brazil	PI0715698
South Korea	20030066713
Japan	2009519893
Taiwan	I388556

Supplementary Protection Certificates for OPSUMIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	122014000056	Germany		PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920	CA 2014 00012	Denmark		PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220
1345920	1490025-2	Sweden		PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
1345920	CR 2014 00012	Denmark		PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227
1345920	300672	Netherlands		PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920	C01345920/01	Switzerland		PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014