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Last Updated: July 19, 2024

OPSUMIT Drug Patent Profile


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Which patents cover Opsumit, and when can generic versions of Opsumit launch?

Opsumit is a drug marketed by Actelion and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in thirty-two 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.

DrugPatentWatch® Generic Entry Outlook for Opsumit

Opsumit was eligible for patent challenges on October 18, 2017.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (macitentan), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for OPSUMIT
Drug Prices for OPSUMIT

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Recent Clinical Trials for OPSUMIT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Janssen, LPPhase 4
American Heart AssociationPhase 4
Janssen Pharmaceutical K.K.Phase 3

See all OPSUMIT clinical trials

Pharmacology for OPSUMIT
Paragraph IV (Patent) Challenges for OPSUMIT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OPSUMIT Tablets macitentan 10 mg 204410 11 2017-10-18

US Patents and Regulatory Information for OPSUMIT

OPSUMIT is protected by five US patents.

Patents protecting OPSUMIT

Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION

Sulfamides and their use as endothelin receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES

Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION

Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 3% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for OPSUMIT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V.   Opsumit macitentan EMEA/H/C/002697
Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Authorised no no yes 2013-12-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for OPSUMIT

When does loss-of-exclusivity occur for OPSUMIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2501
Patent: COMPOSICIONES TERAPEUTICAS
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 07290099
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0715698
Patent: produto, composiÇço farmacÊutica que o contÉm e uso de composto
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 59770
Patent: COMPOSITIONS THERAPEUTIQUES (THERAPEUTIC COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 07002494
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UNA PIRIMIDINA TRISUSTITUIDA EN COMBINACION CON UN COMPUESTO CON PROPIEDADES INHIBITORIAS DE PDE5; Y USO EN EL TRATAMIENTO DE UNA ENFERMEDAD QUE INVOLUCRE VASOCONSTRICCION.
Estimated Expiration: ⤷  Sign Up

China

Patent: 1511365
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0131233
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 14735
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 59246
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 59246
Patent: Compositions thérapeutiques comprenant une antagoniste spécifique pour les récepteurs à l'endothéline et un inhibiteur de la PDE5 (Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 33597
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 7235
Patent: תכשירים רפואיים ומוצר המכילים מרכיבים בעלי תכונות מעכבי pde5, ושימוש בהם ביצור תרופות (Therapeutic compositions and products comprising compounds having pde5-inhibitory properties and their use in the manufacture of medicaments)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 08113
Estimated Expiration: ⤷  Sign Up

Patent: 10502588
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 4591
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 09002057
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN UN ANTAGONISTA DEL RECEPTOR DE ENDOTELINA ESPECIFICO Y UN INHIBIDOR PDE5. (THERAPEUTIC COMPOSITIONS.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 704
Patent: COMPOSITIONS THERAPEUTIQUES
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5702
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 2554
Estimated Expiration: ⤷  Sign Up

Patent: 091254
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 59246
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 59246
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 62249
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОР PDE5 (THERAPEUTIC COMPOSITIONS CONTAINING SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND PDE5 INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Patent: 09111378
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОРОВ PDE5
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 59246
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0902164
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1473022
Estimated Expiration: ⤷  Sign Up

Patent: 090057009
Patent: THERAPEUTIC COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 38792
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 88556
Estimated Expiration: ⤷  Sign Up

Patent: 0823198
Patent: Therapeutic compositions
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OPSUMIT around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2008026156 ⤷  Sign Up
European Patent Office 1693372 ⤷  Sign Up
Hungary 0301654 ⤷  Sign Up
Japan 4955685 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OPSUMIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 14C0017 France ⤷  Sign Up PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920 C01345920/01 Switzerland ⤷  Sign Up PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
1345920 2014/018 Ireland ⤷  Sign Up PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920 CA 2014 00012 Denmark ⤷  Sign Up PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.