Aripiprazole lauroxil - Generic Drug Details
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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 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 |
Anatomical Therapeutic Chemical (ATC) Classes for aripiprazole lauroxil
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 INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | |||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-002 | Oct 5, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | 2019172699 | 神経学的および精神的障害の治療のための複素環式化合物 (HETEROCYCLIC COMPOUNDS FOR TREATMENT OF NEUROLOGICAL AND PSYCHOLOGICAL DISORDERS) | ⤷ Try a Trial |
Japan | 2017507992 | 注射速度が増大したアリピプラゾール調合物 | ⤷ Try a Trial |
Turkey | 201905694 | ⤷ 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 | 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 |
1675573 | 92427 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |