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Macitentan - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for macitentan?

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. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty patent family members in thirty countries.

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

Summary for Generic Name: macitentan

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Bulk Api Vendors: see list36
Clinical Trials: see list23
Patent Applications: see list25
Drug Prices:see low prices
DailyMed Link:macitentan at DailyMed

Pharmacology for Ingredient: macitentan

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, 2013RXYesYes► Subscribe► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes► Subscribe► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes8,367,685► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: macitentan

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 Ingredient: macitentan

Country Document Number Estimated Expiration
Hungary229403► Subscribe
Portugal1928409► Subscribe
Japan5208113► Subscribe
South Korea20080055897► Subscribe
Slovenia1928409► 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: MACITENTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0017France► SubscribePRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920/01Switzerland► SubscribePRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
90025-2Sweden► SubscribePRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
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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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