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Last Updated: February 26, 2021

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ARIPIPRAZOLE Drug Profile

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Which patents cover Aripiprazole, and what generic alternatives are available?

Aripiprazole is a drug marketed by Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Vistapharm, Alembic Pharms Ltd, Orchid Hlthcare, Sciegen Pharms Inc, Zydus Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, and Torrent. and is included in twenty-eight NDAs.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

US ANDA Litigation and Generic Entry Outlook for Aripiprazole

A generic version of ARIPIPRAZOLE was approved as aripiprazole by ALEMBIC PHARMS LTD on April 28th, 2015.

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Drug patent expirations by year for ARIPIPRAZOLE
Drug Prices for ARIPIPRAZOLE

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Drug Sales Revenue Trends for ARIPIPRAZOLE

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Recent Clinical Trials for ARIPIPRAZOLE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Henan Mental HospitalPhase 2
Shanghai Mental Health CenterPhase 2
The First Affiliated Hospital of Kunming Medical CollegePhase 2

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Pharmacology for ARIPIPRAZOLE
Medical Subject Heading (MeSH) Categories for ARIPIPRAZOLE
Paragraph IV (Patent) Challenges for ARIPIPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
ABILIFY SOLUTION;ORAL aripiprazole 021713 2007-12-20
ABILIFY TABLET;ORAL aripiprazole 021436 2006-11-15
ABILIFY TABLET, ORALLY DISINTEGRATING;ORAL aripiprazole 021729 2006-11-15

US Patents and Regulatory Information for ARIPIPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd ARIPIPRAZOLE aripiprazole TABLET;ORAL 204111-003 Oct 7, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ARIPIPRAZOLE aripiprazole TABLET;ORAL 078607-002 Apr 28, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms ARIPIPRAZOLE aripiprazole TABLET;ORAL 204838-002 Jun 17, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd ARIPIPRAZOLE aripiprazole TABLET;ORAL 202101-005 Apr 28, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Medtronic
Baxter
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McKesson

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