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® Litigation and Generic Entry Outlook for Opsumit
A generic version of OPSUMIT was approved as macitentan by APOTEX on January 9th, 2024.
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: | 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: ⤷ 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 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | AB | 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
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07290099
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0715698
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 59770
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 07002494
Estimated Expiration: ⤷ Sign Up
China
Patent: 1511365
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
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 33597
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7235
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 08113
Estimated Expiration: ⤷ Sign Up
Patent: 10502588
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4591
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09002057
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 704
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5702
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
Estimated Expiration: ⤷ Sign Up
Patent: 09111378
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 59246
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0902164
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1473022
Estimated Expiration: ⤷ Sign Up
Patent: 090057009
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 38792
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 88556
Estimated Expiration: ⤷ Sign Up
Patent: 0823198
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 |
|---|---|---|---|
| Morocco | 30704 | COMPOSITIONS THERAPEUTIQUES | ⤷ Sign Up |
| Denmark | 2059246 | ⤷ Sign Up | |
| South Korea | 101473022 | ⤷ 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 | 2014C/019 | Belgium | ⤷ Sign Up | PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227 |
| 1345920 | 122014000056 | Germany | ⤷ Sign Up | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220 |
| 1345920 | 1490025-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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