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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Johnson and Johnson
Cipla
Daiichi Sankyo
Queensland Health
Merck
Medtronic
Mallinckrodt
AstraZeneca

Generated: July 18, 2018

DrugPatentWatch Database Preview

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.
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
{[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 ➤ 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
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

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 ➤ Try a Free Trial
2,013,210,830 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for OPSUMIT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2 Finland ➤ Try a Free Trial
00672 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
381 Luxembourg ➤ Try a Free Trial PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
C0017 France ➤ Try a Free Trial PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Fish and Richardson
Deloitte
Colorcon
Boehringer Ingelheim
McKinsey
Mallinckrodt
UBS
Cipla

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