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Generated: June 29, 2017
What are the generic drug sources for aripiprazole lauroxil and what is the scope of aripiprazole lauroxil freedom to operate?
Aripiprazole lauroxil is the generic ingredient in one branded drug marketed by Alkermes Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 44 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 3 |
| Clinical Trials: see list | 311 |
| Patent Applications: see list | 26 |
| Drug Prices: | see low prices |
| DailyMed Link: | aripiprazole lauroxil at DailyMed |
| 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 | 9,193,685 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-003 | Oct 5, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-003 | Oct 5, 2015 | RX | Yes | Yes | 8,796,276 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-002 | Oct 5, 2015 | RX | Yes | No | 9,193,685 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-002 | Oct 5, 2015 | RX | Yes | No | 8,796,276 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,686,009 | Prodrugs of NH-acidic compounds | ► Subscribe | |||||||||||||||||||||||||||
| 9,351,976 | Pharmaceutical compositions comprising sorbitan esters | ► Subscribe | |||||||||||||||||||||||||||
| 9,102,618 | Prodrugs of NH-acidic compounds | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| New Zealand | 615513 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5732453 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2012231160 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5733841 | ► Subscribe | |||||||||||||||||||||||||||
| Serbia | 55434 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 427 | Luxembourg | ► Subscribe | PRODUCT NAME: ARIPIPRAZOLE | ||||||||||||||||||||||||||
| C/GB04/039 | United Kingdom | ► Subscribe | 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 | ► Subscribe | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 | ||||||||||||||||||||||||||
| 0669 | Netherlands | ► Subscribe | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 | ||||||||||||||||||||||||||
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