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 seventy-eight 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: | 178 |
| US Patents: | 17 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 7 |
| Patent Applications: | 235 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ARIPIPRAZOLE LAUROXIL
Generic Entry Dates for ARIPIPRAZOLE LAUROXIL*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
Generic Entry Dates for ARIPIPRAZOLE LAUROXIL*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
*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 ARIPIPRAZOLE LAUROXIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Miami | Phase 4 |
| University of California, Los Angeles | Phase 4 |
| Alkermes, Inc. | Phase 4 |
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 | 207533-001 | Oct 5, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-004 | Jun 5, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-004 | Jun 5, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-004 | Jun 5, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-002 | Oct 5, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2018090629 | 貯蔵安定性が改善された医薬組成物 (PHARMACEUTICAL COMPOSITIONS HAVING IMPROVED STORAGE STABILITY) | ⤷ Try a Trial |
| Israel | 247517 | פורמולציות של קדם תרופה של אריפיפרזול בעלות זמני הזרקה מוגברים (Aripiprazole formulations having increased injection speeds) | ⤷ Try a Trial |
| Australia | 2019230014 | Aripiprazole dosing strategy | ⤷ Try a Trial |
| Japan | 6765464 | ⤷ Try a Trial | |
| Mexico | 2017002029 | COMPOSICIONES DE PROFARMACOS DE ARIPIPRAZOL. (ARIPIPRAZOLE PRODRUG COMPOSITIONS.) | ⤷ Try a Trial |
| Japan | 2021516241 | アリピプラゾール投与戦略 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARIPIPRAZOLE LAUROXIL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1675573 | C300669 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 92427 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE |
| 1675573 | 300669 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 2014C/029 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
| 0367141 | SPC/GB04/039 | United Kingdom | ⤷ Try a 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 |
