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OPSUMIT Drug Profile

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:	67
Clinical Trials:	7
Patent Applications:	34
Drug Prices:	Drug price information for OPSUMIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OPSUMIT
DailyMed Link:	OPSUMIT at DailyMed

Drug patent expirations by year for OPSUMIT

Generic Entry Opportunity Date for OPSUMIT

Generic Entry Date for OPSUMIT^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial 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.

Recent Clinical Trials for OPSUMIT

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
Ochsner Health System	Phase 4
Medical University of South Carolina	Phase 4

See all OPSUMIT clinical trials

Recent Litigation for OPSUMIT

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Actelion Pharmaceuticals, Ltd. v. Lee	2013-11-14
ACTELION PHARMACEUTICALS LTD. v. KAPPOS	2010-07-06

See all OPSUMIT litigation

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

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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 Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Actelion Pharms Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Actelion Pharms Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Actelion Pharms Ltd	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		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

Paragraph IV (Patent) Challenges for OPSUMIT

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	10 mg	➤ Subscribe	Start Trial

International Patents for OPSUMIT

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Country	Patent Number	Estimated Expiration
Netherlands	300672	Start Trial
Spain	2260318	Start Trial
South Korea	100819668	Start Trial
Australia	2002227984	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for OPSUMIT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	C300672	Netherlands	Start Trial	PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920	122014000056	Germany	Start Trial	PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920	1490025-2	Sweden	Start Trial	PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
1345920	2014C/019	Belgium	Start Trial	PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description