Details for New Drug Application (NDA): 209830
✉ Email this page to a colleague
NDA 209830 describes ARISTADA INITIO KIT, which is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ARISTADA INITIO KIT profile page.
The generic ingredient in ARISTADA INITIO KIT is aripiprazole lauroxil. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aripiprazole lauroxil profile page.
The generic ingredient in ARISTADA INITIO KIT is aripiprazole lauroxil. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aripiprazole lauroxil profile page.
Summary for 209830
| Tradename: | ARISTADA INITIO KIT |
| Applicant: | Alkermes Inc |
| Ingredient: | aripiprazole lauroxil |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209830
*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.
Suppliers and Packaging for NDA: 209830
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830 | NDA | Alkermes, Inc. | 65757-500 | 65757-500-03 | 1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 675MG/2.4ML (281.25MG/ML) | ||||
| Approval Date: | Jun 29, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 8, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 24, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 17, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
