opsumit Drug Patent Profile
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When do Opsumit patents expire, and what generic alternatives are available?
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 three tentative approvals for the generic drug (macitentan), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for opsumit
| International Patents: | 94 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 17 |
| Patent Applications: | 446 |
| 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.
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 | |||
| Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
|---|---|---|---|
| Japan | 5208113 | ⤷ Sign Up | |
| Croatia | P20120957 | ⤷ Sign Up | |
| Norway | 20032699 | ⤷ Sign Up | |
| Japan | 4955685 | ⤷ Sign Up | |
| Slovenia | 2059246 | ⤷ 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 | 92381 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT) |
| 1345920 | C01345920/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014 |
| 1345920 | C300672 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220 |
| 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 | 122014000056 | Germany | ⤷ Sign Up | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 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.
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