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OPSUMIT Drug Profile

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Which patents cover Opsumit, and what substitute generic drugs are available?

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 patent family members in thirty countries.

The generic ingredient in OPSUMIT is macitentan. There are three 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 list6
Patent Applications: see list28
Drug Prices:see details
DailyMed Link:OPSUMIT at DailyMed

Pharmacology for Tradename: OPSUMIT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes8,268,847► Subscribe ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes7,094,781► SubscribeYY ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes8,367,685► SubscribeY ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes9,265,762► SubscribeY ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes► 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
Portugal1345920► Subscribe
Malaysia154591► Subscribe
Slovenia1928409► Subscribe
Japan2010502588► Subscribe
Russian Federation2009111378► 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
14/018Ireland► SubscribePRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
381Luxembourg► SubscribePRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
0672Netherlands► SubscribePRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
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
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