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 four 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
Summary for OPSUMIT
International Patents: | 94 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 91 |
Clinical Trials: | 17 |
Patent Applications: | 543 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07290099
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0715698
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 59770
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 07002494
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1511365
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0131233
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 14735
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 59246
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 59246
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 33597
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 7235
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 08113
Estimated Expiration: ⤷ Try a Trial
Patent: 10502588
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 4591
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09002057
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 704
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 5702
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 2554
Estimated Expiration: ⤷ Try a Trial
Patent: 091254
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 59246
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 59246
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 62249
Estimated Expiration: ⤷ Try a Trial
Patent: 09111378
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 59246
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0902164
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1473022
Estimated Expiration: ⤷ Try a Trial
Patent: 090057009
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 38792
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 88556
Estimated Expiration: ⤷ Try a Trial
Patent: 0823198
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Russian Federation | 2009111378 | ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОРОВ PDE5 | ⤷ Try a Trial |
Chile | 2007002494 | 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. | ⤷ Try a Trial |
Japan | 2010502588 | ⤷ Try a Trial | |
China | 101511365 | Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor | ⤷ Try a Trial |
European Patent Office | 2059246 | 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) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OPSUMIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1345920 | 92381 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT) |
1345920 | 2014/018 | Ireland | ⤷ Try a Trial | PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220 |
1345920 | CR 2014 00012 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227 |
1345920 | 2014C/019 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227 |
1345920 | C01345920/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |