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Last Updated: May 26, 2022

Details for New Drug Application (NDA): 021436


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NDA 021436 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from two suppliers. There are fifty patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ABILIFY profile page.

The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 021436
Tradename:ABILIFY
Applicant:Otsuka
Ingredient:aripiprazole
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 021436
Medical Subject Heading (MeSH) Categories for 021436
Suppliers and Packaging for NDA: 021436
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY aripiprazole TABLET;ORAL 021436 NDA PD-Rx Pharmaceuticals, Inc. 55289-251 55289-251-30 30 TABLET in 1 BOTTLE, PLASTIC (55289-251-30)
ABILIFY aripiprazole TABLET;ORAL 021436 NDA Otsuka America Pharmaceutical, Inc. 59148-006 59148-006-13 30 TABLET in 1 BOTTLE, PLASTIC (59148-006-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 15, 2002TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Jan 28, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:See Plans and PricingPatent Expiration:Dec 16, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:See Plans and PricingPatent Expiration:Mar 25, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021436

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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