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Last Updated: March 19, 2024

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 seven NDAs. It is available from one supplier. There are forty-five 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-eight 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:3
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 Otsuka America Pharmaceutical, Inc. 59148-006 59148-006-13 30 TABLET in 1 BOTTLE, PLASTIC (59148-006-13)
ABILIFY aripiprazole TABLET;ORAL 021436 NDA Otsuka America Pharmaceutical, Inc. 59148-006 59148-006-92 7 TABLET in 1 BLISTER PACK (59148-006-92)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 15, 2002TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 16, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Mar 2, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:⤷  Try a TrialPatent Expiration:Jul 28, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

Expired US Patents for NDA 021436

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.