DrugPatentWatch Database Preview
OPSUMIT Drug Profile
When do Opsumit patents expire, and when can generic versions of Opsumit launch?
This drug has ninety-one patent family members in thirty-one 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.
Summary for OPSUMIT
| International Patents: | 91 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 7 |
| Patent Applications: | 30 |
| Drug Prices: | see details |
| DailyMed Link: | OPSUMIT at DailyMed |
Pharmacology for OPSUMIT
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Endothelin Receptor Antagonists |
Synonyms for OPSUMIT
| (non-labelled)Macitentan-d7 |
| {[5-(4-BROMOPHENYL)-6-{2-[(5-BROMOPYRIMIDIN-2-YL)OXY]ETHOXY}PYRIMIDIN-4-YL]SULFAMOYL}(PROPYL)AMINE |
| 441798-33-0 |
| 5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine |
| AB0007893 |
| ABP001066 |
| ACT 064992 |
| ACT 064992; ACT-064992 |
| ACT-064992 |
| ACT064992 |
| Actelion-1 |
| AK162704 |
| AKOS024463406 |
| AM81244 |
| AOB87765 |
| BC600464 |
| BDBM50395626 |
| C19H20Br2N6O4S |
| cas:441798-33-0;Macitentan |
| CHEBI:76607 |
| CHEMBL2103873 |
| CHEMBL3187061 |
| CS-0686 |
| D0S7JH |
| D10135 |
| DB08932 |
| DTXSID50196063 |
| EX-A544 |
| FT-0696675 |
| GTPL7352 |
| HE072094 |
| HE343528 |
| HMS3653N06 |
| HY-14184 |
| JGCMEBMXRHSZKX-UHFFFAOYSA-N |
| KS-000005UM |
| Macitentan |
| Macitentan (Actelion-1,ACT-064992) |
| Macitentan (JAN/USAN) |
| Macitentan [USAN:INN] |
| macitentanum |
| MFCD17167076 |
| MLS006011174 |
| MolPort-023-299-418 |
| N-(5-(4-Bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-N'-propylsulfamide |
| N-(5-(4-Bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxy)ethoxy)pyrimidin-4-yl)-N'-propylsulfamide |
| n-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propyl-sulfamide |
| N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide |
| N-[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-N'-propylsulfuric diamide |
| NCGC00346456-01 |
| Opsumit (TN) |
| QC-10426 |
| S-7749 |
| s8051 |
| SCHEMBL1445625 |
| SMR004702943 |
| ST24048423 |
| Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl- |
| UNII-Z9K9Y9WMVL |
| X6162 |
| Z9K9Y9WMVL |
| ZINC43202140 |
| ZLA0005 |
| zlchem 5 |
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 Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | 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 |
Paragraph IV (Patent) Challenges for OPSUMIT
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg | ➤ Subscribe | 2017-10-18 |
Non-Orange Book US Patents for OPSUMIT
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,285,549 | Sulfamides and their use as endothelin receptor antagonists | ➤ Sign Up |
| 2,013,210,830 | ➤ Sign Up | |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for OPSUMIT
Supplementary Protection Certificates for OPSUMIT
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2 | Finland | ➤ Sign Up | |
| 0672 | 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 |
| 2014000056 | Germany | ➤ Sign Up | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220 |
| 2014 00012 | Denmark | ➤ Sign Up | PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
