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Generated: March 22, 2019

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Macitentan - Generic Drug Details

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What are the generic sources for macitentan and what is the scope of macitentan patent protection?

Macitentan is the generic ingredient in one branded drug marketed by Actelion Pharms Ltd and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Macitentan has ninety-one patent family members in thirty-one countries.

There are ten drug master file entries for macitentan. One supplier is listed for this compound.

Pharmacology for macitentan
Synonyms for macitentan
(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 (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
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 macitentan

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 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 ➤ 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
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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Supplementary Protection Certificates for macitentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 2014C/019 Belgium ➤ Try a Free Trial PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227
1345920 502 Finland ➤ Try a Free Trial
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 CR 2014 00012 Denmark ➤ Try a Free Trial PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Army
Fuji
Covington
Mallinckrodt
US Department of Justice

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