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Generated: April 23, 2019

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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.

Drug patent expirations by year for OPSUMIT
Generic Entry Opportunity Date for OPSUMIT
Generic Entry Date for OPSUMIT*:
Constraining patent/regulatory exclusivity:
NDA:
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
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for OPSUMIT
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 10 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for OPSUMIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 122014000056 Germany ➤ Try a Free Trial PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 CA 2014 00012 Denmark ➤ Try a Free Trial PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220
1345920 1490025-2 Sweden ➤ Try a Free Trial PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
1345920 CR 2014 00012 Denmark ➤ Try a Free Trial PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227
1345920 300672 Netherlands ➤ Try a Free Trial 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 ➤ Try a Free Trial PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Daiichi Sankyo
AstraZeneca
Teva
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