Details for New Drug Application (NDA): 209830
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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 nine 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 is one drug master file entry 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 is one drug master file entry 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: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209830
Generic Entry Date for 209830*:
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.
Pharmacology for NDA: 209830
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 |
| ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830 | NDA | Alkermes, Inc. | 65757-500 | 65757-500-04 | 1 SYRINGE in 1 CARTON (65757-500-04) / 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: | 10,016,415 | Patent Expiration: | Sep 8, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,112,903 | Patent Expiration: | Jun 24, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
| Patent: | 10,688,091 | Patent Expiration: | Aug 17, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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