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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Queensland Health
US Army

Generated: December 11, 2017

DrugPatentWatch Database Preview

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 one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ARISTADA profile page.

The generic ingredient in ARISTADA is aripiprazole lauroxil. There are forty-four 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


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 (65757-401-01)
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 (65757-402-01)

Summary for product number 001

Approval Date:Oct 5, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Oct 26, 2030Product Flag?Substance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Jun 24, 2030Product Flag?Substance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
Express Scripts
Argus Health
US Department of Justice
Queensland Health
Fish and Richardson

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