Details for New Drug Application (NDA): 207533
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NDA 207533 describes ARISTADA, which is a drug marketed by Alkermes Inc and is included in two NDAs. It is available from one supplier. There are twenty-two patents protecting this drug. Additional details are available on the ARISTADA profile page.
The generic ingredient in ARISTADA 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 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 207533
| Tradename: | ARISTADA |
| Applicant: | Alkermes Inc |
| Ingredient: | aripiprazole lauroxil |
| Patents: | 18 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207533
Generic Entry Date for 207533*:
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: 207533
Suppliers and Packaging for NDA: 207533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533 | NDA | Alkermes, Inc. | 65757-401 | 65757-401-03 | 1 SYRINGE in 1 CARTON (65757-401-03) / 1.6 mL in 1 SYRINGE |
| ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533 | NDA | Alkermes, Inc. | 65757-401 | 65757-401-04 | 1 SYRINGE in 1 CARTON (65757-401-04) / 1.6 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 441MG/1.6ML (275.63MG/ML) | ||||
| Approval Date: | Oct 5, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 10,112,903 | Patent Expiration: | Jun 24, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
| Patent: | 10,226,458 | Patent Expiration: | Mar 19, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
| Patent: | 10,238,651 | Patent Expiration: | Mar 19, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION | ||||||||
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