➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Boehringer Ingelheim
McKesson
Colorcon
Mallinckrodt

Last Updated: June 5, 2020

DrugPatentWatch Database Preview

OPSUMIT Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which patents cover Opsumit, 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-four patent family members in thirty-two 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.

US ANDA Litigation and Generic Entry Outlook for Opsumit

Opsumit was eligible for patent challenges on October 18, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 18, 2029. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Drug patent expirations by year for OPSUMIT
Drug Prices for OPSUMIT

See drug prices 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.

Recent Clinical Trials for OPSUMIT

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

SponsorPhase
ActelionPhase 3
Janssen Research & Development, LLCPhase 1
University of California, Los AngelesPhase 4

See all OPSUMIT clinical trials

Recent Litigation for OPSUMIT

Identify potential future generic entrants

District Court Litigation
Case NameDate
ACTELION PHARMACEUTICALS LTD v. AUROBINDO PHARMA USA INC.2019-07-16
Actelion Pharmaceuticals, Ltd. v. Lee2013-11-14
ACTELION PHARMACEUTICALS LTD. v. KAPPOS2010-07-06

See all OPSUMIT litigation

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
A11492
AB0007893
ABP001066
AC-30102
ACN-034475
ACT 064992
ACT 064992; ACT-064992
ACT-064992
ACT064992
Actelion-1
AK162704
AKOS024463406
AM81244
AOB87765
AS-74590
BCP05309
BDBM50395626
C19H20Br2N6O4S
cas:441798-33-0;Macitentan
CHEBI:76607
CHEMBL2103873
CS-0686
D10135
DB-070519
DB08932
DTXSID50196063
EX-A544
FT-0696675
GTPL7352
HMS3653N06
HMS3747E09
HY-14184
JGCMEBMXRHSZKX-UHFFFAOYSA-N
KS-000005UM
Macitentan
Macitentan (Actelion-1,ACT-064992)
Macitentan (JAN/USAN)
Macitentan [USAN:INN]
macitentanum
MLS006011174
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)
Q6724151
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
ZINC000043202140
ZINC43202140
ZLA0005
zlchem 5
Paragraph IV (Patent) Challenges for OPSUMIT
Tradename Dosage Ingredient NDA Submissiondate
OPSUMIT TABLET;ORAL macitentan 204410

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   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

Supplementary Protection Certificates for OPSUMIT

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 CA 2014 00012 Denmark   Start Trial PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220
1345920 C01345920/01 Switzerland   Start Trial PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Boehringer Ingelheim
McKesson
Colorcon
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.