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OPSUMIT Drug Profile
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» See Plans and PricingWhich 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.
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.
US ANDA Litigation and Generic Entry Outlook for Opsumit
Opsumit was eligible for patent challenges on October 18, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 18, 2029. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for OPSUMIT
| International Patents: | 94 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 72 |
| Clinical Trials: | 9 |
| Patent Applications: | 35 |
| 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
Generic Entry Date for OPSUMIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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.
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 |
Recent Litigation for OPSUMIT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ACTELION PHARMACEUTICALS LTD v. AUROBINDO PHARMA USA INC. | 2019-07-16 |
| Actelion Pharmaceuticals, Ltd. v. Lee | 2013-11-14 |
| ACTELION PHARMACEUTICALS LTD. v. KAPPOS | 2010-07-06 |
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 |
| A11492 |
| AB0007893 |
| ABP001066 |
| AC-30102 |
| ACN-034475 |
| ACT 064992 |
| ACT 064992; ACT-064992 |
| ACT-064992 |
| ACT064992 |
| Actelion-1 |
| AK162704 |
| AKOS024463406 |
| AM81244 |
| AOB87765 |
| AS-74590 |
| BCP05309 |
| BDBM50395626 |
| C19H20Br2N6O4S |
| cas:441798-33-0;Macitentan |
| CHEBI:76607 |
| CHEMBL2103873 |
| CS-0686 |
| D10135 |
| DB-070519 |
| DB08932 |
| DTXSID50196063 |
| EX-A544 |
| FT-0696675 |
| GTPL7352 |
| HMS3653N06 |
| HMS3747E09 |
| HY-14184 |
| JGCMEBMXRHSZKX-UHFFFAOYSA-N |
| KS-000005UM |
| Macitentan |
| Macitentan (Actelion-1,ACT-064992) |
| Macitentan (JAN/USAN) |
| Macitentan [USAN:INN] |
| macitentanum |
| MLS006011174 |
| 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) |
| Q6724151 |
| QC-10426 |
| S-7749 |
| s8051 |
| SB14841 |
| SCHEMBL1445625 |
| SMR004702943 |
| ST24048423 |
| Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl- |
| SW219473-1 |
| UNII-Z9K9Y9WMVL |
| X6162 |
| Z9K9Y9WMVL |
| ZINC000043202140 |
| ZINC43202140 |
| ZLA0005 |
| zlchem 5 |
Paragraph IV (Patent) Challenges for OPSUMIT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OPSUMIT | TABLET;ORAL | macitentan | 204410 |
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 | 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 OPSUMIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1693372 | Start Trial |
| European Patent Office | 1345920 | Start Trial |
| Hungary | 0301654 | Start Trial |
| Israel | 197235 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OPSUMIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1345920 | C300672 | 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 | 122014000056 | Germany | Start Trial | PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220 |
| 1345920 | CA 2014 00012 | Denmark | Start Trial | PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 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 |
