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Generated: September 21, 2017

DrugPatentWatch Database Preview

OPSUMIT Drug Profile

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What is the patent landscape for 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.

This drug has eighty-two patent family members in thirty-one countries.

The generic ingredient in OPSUMIT is macitentan. There are nine 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 Tradename: OPSUMIT

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list35
Clinical Trials: see list7
Patent Applications: see list29
Drug Prices:see details
DailyMed Link:OPSUMIT at DailyMed

Pharmacology for Tradename: 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;ORAL204410-001Oct 18, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: 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
7,285,549Sulfamides and their use as endothelin receptor antagonists► Subscribe
2,013,210,830► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: OPSUMIT

Country Document Number Estimated Expiration
South Korea20080055897► Subscribe
Taiwan200823198► Subscribe
Slovenia2059246► Subscribe
South Africa200303695► Subscribe
Norway20091254► Subscribe
Cyprus1113395► Subscribe
Cyprus1114735► Subscribe
Mexico2009002057► Subscribe
Chile2007002494► Subscribe
South Africa200902164► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OPSUMIT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0017France► SubscribePRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
2014000056Germany► SubscribePRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
2Finland► Subscribe
381Luxembourg► SubscribePRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
90025-2Sweden► SubscribePRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
0672Netherlands► SubscribePRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920/01Switzerland► SubscribePRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
2014 00012Denmark► SubscribePRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220
00672Netherlands► SubscribePRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
14/018Ireland► SubscribePRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Merck
Novartis
Healthtrust
McKinsey
Dow
Queensland Health
Cipla
Daiichi Sankyo
Argus Health

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 verifification 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.

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