DrugPatentWatch Database Preview
OPSUMIT Drug Profile
Which patents cover Opsumit, and when can generic versions of Opsumit launch?
Opsumit is a drug marketed by Actelion Pharms Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
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
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 7 |
| Patent Applications: | 31 |
| Drug Prices: | Drug price information for OPSUMIT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OPSUMIT |
| DailyMed Link: | OPSUMIT at DailyMed |
Generic Entry Opportunity Date for OPSUMIT
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for OPSUMIT
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hungary | 229403 | ➤ Sign Up |
| Mexico | 2009002057 | ➤ Sign Up |
| Russian Federation | 2008113869 | ➤ Sign Up |
| Taiwan | 200803860 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for OPSUMIT
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 381 | Luxembourg | ➤ Sign Up | PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT) |
| 90025-2 | Sweden | ➤ Sign Up | PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220 |
| 1345920/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014 |
| 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
