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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Dow
Colorcon
Chinese Patent Office
Chubb
Farmers Insurance
Accenture
Fuji
Cantor Fitzgerald

Generated: January 20, 2018

DrugPatentWatch Database Preview

OPSUMIT Drug Profile

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When do Opsumit patents expire, 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-one patent family members in thirty-one 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.
Summary for OPSUMIT
International Patents:91
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 48
Clinical Trials: 7
Patent Applications: 29
Drug Prices:see details
DailyMed Link:OPSUMIT at DailyMed
Drug patent expirations by year for OPSUMIT
Pharmacology for OPSUMIT

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 ➤ Subscribe ➤ Subscribe Y 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 Y ➤ 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
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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Paragraph IV (Patent) Challenges for OPSUMIT
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 10 mg ➤ Subscribe 10/18/2017

Non-Orange Book US Patents for 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
7,285,549 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 OPSUMIT

Supplementary Protection Certificates for OPSUMIT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2 Finland ➤ Subscribe
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
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
14/018 Ireland ➤ Subscribe PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; 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
90025-2 Sweden ➤ Subscribe PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
C0017 France ➤ Subscribe PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
2014000056 Germany ➤ Subscribe PRODUCT NAME: MACITENTAN; 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Chubb
Farmers Insurance
Fuji
Mallinckrodt
Boehringer Ingelheim
Daiichi Sankyo
Johnson and Johnson
McKinsey
Cerilliant

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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