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Serving leading biopharmaceutical companies globally:

Moodys
UBS
Boehringer Ingelheim
Colorcon
Healthtrust
Cerilliant
Teva
QuintilesIMS
Citi
Daiichi Sankyo

Generated: January 23, 2018

DrugPatentWatch Database Preview

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. 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.
Summary for macitentan
International Patents:91
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 10
Suppliers / Packagers: 1
Bulk Api Vendors: 48
Clinical Trials: 34
Patent Applications: 46
Drug Prices:see low prices
DailyMed Link:macitentan at DailyMed
Pharmacology for macitentan

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Actelion Pharms Ltd OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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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Non-Orange Book US Patents for 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
7,285,549 Sulfamides and their use as endothelin receptor antagonists ➤ Subscribe
2,013,210,830 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for macitentan

Supplementary Protection Certificates for macitentan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0017 France ➤ Subscribe PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
381 Luxembourg ➤ Subscribe PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
1345920/01 Switzerland ➤ Subscribe PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
14/018 Ireland ➤ Subscribe PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
90025-2 Sweden ➤ Subscribe PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
2014000056 Germany ➤ Subscribe PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
0672 Netherlands ➤ Subscribe PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
2014 00012 Denmark ➤ Subscribe PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220
2 Finland ➤ Subscribe
00672 Netherlands ➤ Subscribe PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
McKesson
Boehringer Ingelheim
US Department of Justice
US Army
Cipla
AstraZeneca
Medtronic

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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