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Aripiprazole lauroxil - Generic Drug Details
What are the generic drug sources for aripiprazole lauroxil and what is the scope of freedom to operate?
Aripiprazole lauroxil
is the generic ingredient in two branded drugs marketed by Alkermes Inc and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Aripiprazole lauroxil has one hundred and fourteen patent family members in twenty-six countries.
There are forty-nine drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.
Summary for aripiprazole lauroxil
| International Patents: | 114 |
| US Patents: | 10 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 49 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 5 |
| Patent Applications: | 41 |
| DailyMed Link: | aripiprazole lauroxil at DailyMed |
Recent Clinical Trials for aripiprazole lauroxil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alkermes, Inc. | Phase 4 |
| Alkermes, Inc. | Phase 1 |
| Alkermes, Inc. | Phase 3 |
Synonyms for aripiprazole lauroxil
| (7-(4-(4-(2,3-Dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquinolin-1(2H)-yl)methyl dodecanoate |
| [7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-2-oxo-3,4-dihydroquinolin-1-yl]methyl dodecanoate |
| [7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-2-oxo-3,4-dihydroquinolin-1(2H)-yl]methyl dodecanoate |
| 1259305-29-7 |
| AKOS030627657 |
| ALKS 9070 |
| ALKS 9072 |
| Aripiprazol- Lauroxil |
| Aripiprazole lauroxil (USAN) |
| Aripiprazole lauroxil [USAN] |
| Aristada |
| Aristada (TN) |
| AS-35241 |
| B786J7A343 |
| BCP14993 |
| CHEBI:90930 |
| CHEMBL2219425 |
| D10364 |
| Dodecanoic acid [7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2-oxo-1(2H)-quinolinyl]methyl ester |
| Dodecanoic acid, (7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-2-oxo-1(2H)-quinolinyl)methyl ester |
| DTXSID60154997 |
| RDC 3317 |
| RDC-3317 |
| SCHEMBL1044330 |
| UNII-B786J7A343 |
| ZINC95564895 |
US Patents and Regulatory Information for aripiprazole lauroxil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-002 | Oct 5, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-002 | Oct 5, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-001 | Oct 5, 2015 | RX | Yes | No | Start Trial | Start Trial | 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 aripiprazole lauroxil
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2015143145 | Start Trial |
| Poland | 3182958 | Start Trial |
| San Marino | T201600423 | Start Trial |
| Australia | 2013349388 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for aripiprazole lauroxil
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1675573 | C300669 | Netherlands | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 300669 | Netherlands | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 2014C/029 | Belgium | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
| 0367141 | SPC/GB04/039 | United Kingdom | Start Trial | PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
