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Aripiprazole lauroxil - Generic Drug Details
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What are the generic drug sources for aripiprazole lauroxil and what is the scope of aripiprazole lauroxil freedom to operate?
Aripiprazole lauroxil has seventy-seven patent family members in twenty-six countries.
There are forty-five drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.
Summary for aripiprazole lauroxil
| International Patents: | 77 |
| US Patents: | 6 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 45 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 10 |
| Clinical Trials: | 5 |
| Patent Applications: | 31 |
| DailyMed Link: | aripiprazole lauroxil at DailyMed |
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) |
| B786J7A343 |
| 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 |
| MFCD26967976 |
| 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 | 207533-003 | Oct 5, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-002 | Oct 5, 2015 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-003 | Oct 5, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-001 | Oct 5, 2015 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for aripiprazole lauroxil
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 |
|---|---|---|
| 9,861,699 | Pharmaceutical compositions having improved storage stability | ➤ Sign Up |
| 9,351,976 | Pharmaceutical compositions comprising sorbitan esters | ➤ Sign Up |
| 8,686,009 | Prodrugs of NH-acidic compounds | ➤ Sign Up |
| 9,102,618 | Prodrugs of NH-acidic compounds | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for aripiprazole lauroxil
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Slovenia | 2445502 | ➤ Sign Up |
| Poland | 2685979 | ➤ Sign Up |
| Serbia | 56352 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2010151689 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for aripiprazole lauroxil
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0669 | Netherlands | ➤ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 427 | Luxembourg | ➤ Sign Up | PRODUCT NAME: ARIPIPRAZOLE |
| C/GB04/039 | United Kingdom | ➤ Sign Up | 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 |
| 00669 | Netherlands | ➤ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
