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OPSUMIT Drug 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 four 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 ZYDUS on April 6th, 2021.
Summary for OPSUMIT
| International Patents: | 94 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 10 |
| Patent Applications: | 488 |
| 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 |
|---|---|
| Actelion | Phase 3 |
| Janssen Research & Development, LLC | Phase 1 |
| University of California, Los Angeles | Phase 4 |
Pharmacology for OPSUMIT
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Endothelin Receptor Antagonists |
Paragraph IV (Patent) Challenges for OPSUMIT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OPSUMIT | TABLET;ORAL | macitentan | 204410 | 2017-10-18 |
US Patents and Regulatory Information for OPSUMIT
| 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 | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | AB | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | |
| Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | AB | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OPSUMIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0116237 | Try Before You Buy |
| China | 1524079 | Try Before You Buy |
| Taiwan | I388556 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OPSUMIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1345920 | 2014/018 | Ireland | Try Before You Buy | 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 Before You Buy | PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227 |
| 1345920 | 132014902244514 | Italy | Try Before You Buy | PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
