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Last Updated: March 30, 2023

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 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.
Summary for 209830
Applicant:Alkermes Inc
Ingredient:aripiprazole lauroxil
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 209830
Generic Entry Date for 209830*:
Constraining patent/regulatory exclusivity:

*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
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

Approval Date:Jun 29, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 8, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 24, 2030Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 17, 2035Product Flag?YSubstance Flag?Delist Request?

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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.