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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-one 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:	91
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	55
Clinical Trials:	7
Patent Applications:	30
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

{[5-(4-BROMOPHENYL)-6-{2-[(5-BROMOPYRIMIDIN-2-YL)OXY]ETHOXY}PYRIMIDIN-4-YL]SULFAMOYL}(PROPYL)AMINE

441798-33-0

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

AB0007893

ABP001066

ACT 064992

ACT 064992; ACT-064992

ACT-064992

ACT064992

Actelion-1

AK162704

AKOS024463406

AM81244

AOB87765

BC600464

BDBM50395626

C19H20Br2N6O4S

cas:441798-33-0;Macitentan

CHEBI:76607

CHEMBL2103873

CHEMBL3187061

CS-0686

D0S7JH

D10135

DB08932

DTXSID50196063

EX-A544

FT-0696675

GTPL7352

HE072094

HE343528

HMS3653N06

HY-14184

JGCMEBMXRHSZKX-UHFFFAOYSA-N

KS-000005UM

Macitentan

Macitentan (Actelion-1,ACT-064992)

Macitentan (JAN/USAN)

Macitentan [USAN:INN]

macitentanum

MFCD17167076

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

SCHEMBL1445625

SMR004702943

ST24048423

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

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

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Paragraph IV (Patent) Challenges for OPSUMIT

Drugname	Dosage	Strength	RLD	Date
	Tablets	10 mg

Non-Orange Book US Patents for OPSUMIT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,285,549	Sulfamides and their use as endothelin receptor antagonists
2,013,210,830

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International Patents for OPSUMIT

Country	Document Number	Estimated Expiration
Israel	155805
Croatia	P20131233
Japan	5208113
Taiwan	200803860

Supplementary Protection Certificates for OPSUMIT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2	Finland
00672	Netherlands		PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
381	Luxembourg		PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
C0017	France		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220