Aripiprazole lauroxil - Generic Drug Details
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What are the generic 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 seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Aripiprazole lauroxil has one hundred and sixty-seven patent family members in twenty-nine countries.
There are three drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.
Summary for aripiprazole lauroxil
| International Patents: | 167 |
| US Patents: | 17 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 29 |
| Clinical Trials: | 6 |
| Patent Applications: | 263 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aripiprazole lauroxil |
| What excipients (inactive ingredients) are in aripiprazole lauroxil? | aripiprazole lauroxil excipients list |
| DailyMed Link: | aripiprazole lauroxil at DailyMed |
Recent Clinical Trials for aripiprazole lauroxil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Los Angeles | Phase 4 |
| Alkermes, Inc. | Phase 4 |
| Alkermes, Inc. | Phase 1 |
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-003 | Oct 5, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-002 | Oct 5, 2015 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-003 | Oct 5, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-003 | Oct 5, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-004 | Jun 5, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-004 | Jun 5, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 | Title | Estimated Expiration |
|---|---|---|---|
| China | 110368360 | 具有增加的注射速度的阿立哌唑制剂 (Aripiprazole formulations having increased injection speeds) | See Plans and Pricing |
| Australia | 2019230014 | Aripiprazole dosing strategy | See Plans and Pricing |
| Australia | 2012231160 | Pharmaceutical compositions comprising sorbitan esters | See Plans and Pricing |
| Spain | 2721270 | See Plans and Pricing | |
| Canada | 3092335 | STRATEGIE DE DOSAGE D'ARIPIPRAZOLE (ARIPIPRAZOLE DOSING STRATEGY) | See Plans and Pricing |
| New Zealand | 713984 | Pharmaceutical compositions comprising sorbitan esters | See Plans and Pricing |
| Spain | 2639065 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aripiprazole lauroxil
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0367141 | SPC/GB04/039 | United Kingdom | See Plans and Pricing | 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 |
| 1675573 | C300669 | Netherlands | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 300669 | Netherlands | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 2014C/029 | Belgium | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
| 1675573 | 92427 | Luxembourg | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOLE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
