OPSUMIT Drug Patent Profile
✉ Email this page to a colleague
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-nine patent family members in thirty-four 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 three tentative approvals for the generic drug (macitentan), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for OPSUMIT?
- What are the global sales for OPSUMIT?
- What is Average Wholesale Price for OPSUMIT?
Summary for OPSUMIT
International Patents: | 99 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 17 |
Patent Applications: | 686 |
Drug Prices: | Drug price information for OPSUMIT |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OPSUMIT |
What excipients (inactive ingredients) are in OPSUMIT? | OPSUMIT excipients list |
DailyMed Link: | OPSUMIT at DailyMed |


Recent Clinical Trials for OPSUMIT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen, LP | Phase 4 |
American Heart Association | Phase 4 |
Janssen Pharmaceutical K.K. | Phase 3 |
Pharmacology for OPSUMIT
Drug Class | Endothelin Receptor Antagonist |
Mechanism of Action | Endothelin Receptor Antagonists |
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 and one FDA Regulatory Exclusivity.
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 | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
>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: ⤷ Try for Free
Australia
Patent: 07290099
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0715698
Patent: produto, composiÇço farmacÊutica que o contÉm e uso de composto
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 59770
Patent: COMPOSITIONS THERAPEUTIQUES (THERAPEUTIC COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
China
Patent: 1511365
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0131233
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 14735
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 59246
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Finland
Patent: 0240045
Estimated Expiration: ⤷ Try for Free
France
Patent: C1054
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 33597
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 400046
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Japan
Patent: 08113
Estimated Expiration: ⤷ Try for Free
Patent: 10502588
Estimated Expiration: ⤷ Try for Free
Malaysia
Patent: 4591
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 09002057
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN UN ANTAGONISTA DEL RECEPTOR DE ENDOTELINA ESPECIFICO Y UN INHIBIDOR PDE5. (THERAPEUTIC COMPOSITIONS.)
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 704
Patent: COMPOSITIONS THERAPEUTIQUES
Estimated Expiration: ⤷ Try for Free
Netherlands
Patent: 1308
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 5702
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷ Try for Free
Norway
Patent: 2554
Estimated Expiration: ⤷ Try for Free
Patent: 24059
Estimated Expiration: ⤷ Try for Free
Patent: 091254
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 59246
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 59246
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Patent: 09111378
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОРОВ PDE5
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 59246
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 0902164
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1473022
Estimated Expiration: ⤷ Try for Free
Patent: 090057009
Patent: THERAPEUTIC COMPOSITIONS
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 38792
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 88556
Estimated Expiration: ⤷ Try for Free
Patent: 0823198
Patent: Therapeutic compositions
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
South Korea | 20080055897 | STABLE PHARMACEUTICAL COMPOSITION COMPRISING A PYRIMIDINE-SULFAMIDE | ⤷ Try for Free |
Spain | 2438792 | ⤷ Try for Free | |
Norway | 2014014 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 2007031933 | ⤷ Try for Free | |
Canada | 2431675 | NOUVEAUX SULFAMIDES ET LEUR UTILISATION COMME ANTAGONISTES DU RECEPTEUR DE L'ENDOTHELINE (NOVEL SULFAMIDES AND THEIR USE AS ENDOTHELIN RECEPTOR ANTAGONISTS) | ⤷ Try for Free |
European Patent Office | 1693372 | ⤷ Try for Free | |
Russian Federation | 2462249 | ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОР PDE5 (THERAPEUTIC COMPOSITIONS CONTAINING SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND PDE5 INHIBITOR) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OPSUMIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1345920 | 122014000056 | Germany | ⤷ Try for Free | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220 |
1345920 | C300672 | Netherlands | ⤷ Try for Free | PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220 |
1345920 | 92381 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT) |
1345920 | 2014C/019 | Belgium | ⤷ Try for Free | PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227 |
1345920 | 2014/018 | Ireland | ⤷ Try for Free | PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220 |
1345920 | 300672 | Netherlands | ⤷ Try for Free | PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220 |
1345920 | 1490025-2 | Sweden | ⤷ Try for Free | PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Opsumit
More… ↓