Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Colorcon
Harvard Business School
Express Scripts
McKinsey

Last Updated: December 15, 2019

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ABILIFY MYCITE KIT Drug Profile

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Which patents cover Abilify Mycite Kit, and what generic alternatives are available?

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

This drug has six hundred and fifty-four 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-four 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 launched as aripiprazole by ALEMBIC PHARMS LTD on December 15th, 2019.

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

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

SponsorPhase
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 4

See all ABILIFY MYCITE KIT clinical trials

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

See all ABILIFY MYCITE KIT litigation

PTAB Litigation
PetitionerDate
Alkermes Pharma Ireland Limited2016-11-17

See all ABILIFY MYCITE KIT litigation

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 207202-002 Nov 13, 2017 RX Yes Yes   Start Trial   Start Trial   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
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 RX Yes No   Start Trial   Start Trial Y 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 C300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0367141 SPC/GB04/039 United Kingdom   Start Trial PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
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:

McKesson
Moodys
Colorcon
Boehringer Ingelheim
Johnson and Johnson
Medtronic

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