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Last Updated: April 4, 2020

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ABILIFY MYCITE KIT Drug Profile


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Which patents cover Abilify Mycite Kit, and when can generic versions of Abilify Mycite Kit launch?

Abilify Mycite Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are thirty-one patents protecting this drug.

This drug has six hundred and forty-seven patent family members in forty-one countries.

The generic ingredient in ABILIFY MYCITE KIT 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 Abilify Mycite Kit

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

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Drug patent expirations by year for ABILIFY MYCITE KIT
Recent Clinical Trials for ABILIFY MYCITE KIT

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SponsorPhase
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 4

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Recent Litigation for ABILIFY MYCITE KIT

Identify potential future generic entrants

District Court Litigation
Case NameDate
OTSUKA PHARMACEUTICAL CO., LTD. v. ALKEM LABORATORIES LIMITED2016-09-26
Otsuka Pharmaceutical Co. v. Zydus Pharmaceuticals USA2016-05-03
OTSUKA PHARMACEUTICAL CO., LTD. v. STASON INDUSTRIAL CORP.2016-02-01

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PTAB Litigation
PetitionerDate
2016-11-17

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Pharmacology for ABILIFY MYCITE KIT

US Patents and Regulatory Information for ABILIFY MYCITE KIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ABILIFY MYCITE KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 92427 Luxembourg   Start Trial PRODUCT NAME: ARIPIPRAZOLE
1675573 2014C/029 Belgium   Start Trial PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Merck
Medtronic
Boehringer Ingelheim
McKinsey

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