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Last Updated: May 28, 2024

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 seventeen patents protecting this drug. Additional details are available on the ARISTADA profile page.

The generic ingredient in ARISTADA 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 207533
Tradename:ARISTADA
Applicant:Alkermes Inc
Ingredient:aripiprazole lauroxil
Patents:13
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.

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. 65757-402 65757-402-03 1 SYRINGE in 1 CARTON (65757-402-03) / 2.4 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength441MG/1.6ML (275.63MG/ML)
Approval Date:Oct 5, 2015TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 24, 2030Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF SCHIZOPHRENIA
Patent:⤷  Sign UpPatent Expiration:Mar 19, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SCHIZOPHRENIA
Patent:⤷  Sign UpPatent Expiration:Mar 19, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.