DrugPatentWatch Database Preview
Macitentan - Generic Drug Details
» See Plans and Pricing
What are the generic drug sources for macitentan and what is the scope of patent protection?
Macitentan
is the generic ingredient in one branded drug marketed by Actelion Pharms Ltd and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Macitentan has ninety-four patent family members in thirty-two countries.
There are ten drug master file entries for macitentan. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for macitentan
| International Patents: | 94 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 10 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 76 |
| Clinical Trials: | 47 |
| Patent Applications: | 1,006 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for macitentan |
| What excipients (inactive ingredients) are in macitentan? | macitentan excipients list |
| DailyMed Link: | macitentan at DailyMed |
Recent Clinical Trials for macitentan
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen, LP | Phase 2/Phase 3 |
| Assistance Publique - Hôpitaux de Paris | Phase 2/Phase 3 |
| Janssen Pharmaceutical K.K. | Phase 1 |
Generic filers with tentative approvals for MACITENTAN
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 10MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for macitentan
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Endothelin Receptor Antagonists |
Paragraph IV (Patent) Challenges for MACITENTAN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OPSUMIT | TABLET;ORAL | macitentan | 204410 | 2017-10-18 |
US Patents and Regulatory Information for macitentan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 macitentan
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5054061 | Start Trial |
| China | 100432070 | Start Trial |
| Malaysia | 129150 | Start Trial |
| European Patent Office | 2059246 | Start Trial |
| Portugal | 2059246 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for macitentan
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1345920 | 502 | Finland | Start Trial | |
| 1345920 | CR 2014 00012 | Denmark | Start Trial | PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227 |
| 1345920 | CA 2014 00012 | Denmark | Start Trial | PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220 |
| 1345920 | 300672 | Netherlands | Start Trial | PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220 |
| 1345920 | C01345920/01 | Switzerland | Start Trial | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2021 - 2022
NCE-1 Patent Challenge Dates 2021 - 2022
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.
Follow DrugPatentWatch:
