ABILIFY MAINTENA KIT Drug Patent Profile
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When do Abilify Maintena Kit patents expire, and when can generic versions of Abilify Maintena Kit launch?
Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and forty-three patent family members in thirty-eight countries.
The generic ingredient in ABILIFY MAINTENA KIT 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Abilify Maintena Kit
A generic version of ABILIFY MAINTENA KIT was approved as aripiprazole by ALEMBIC PHARMS LTD on April 28th, 2015.
Summary for ABILIFY MAINTENA KIT
International Patents: | 243 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 9 |
Patent Applications: | 4,851 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ABILIFY MAINTENA KIT |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABILIFY MAINTENA KIT |
DailyMed Link: | ABILIFY MAINTENA KIT at DailyMed |


Recent Clinical Trials for ABILIFY MAINTENA KIT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Otsuka Beijing Research Institute | Phase 1 |
Chonbuk National University Hospital | Phase 4 |
Otsuka Pharmaceutical Co., Ltd. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ABILIFY MAINTENA KIT
Paragraph IV (Patent) Challenges for ABILIFY MAINTENA KIT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ABILIFY MAINTENA KIT | Extended-release Injectable Suspension | aripiprazole | 300 mg/vial and 400 mg/vial | 202971 | 1 | 2021-12-20 |
US Patents and Regulatory Information for ABILIFY MAINTENA KIT
ABILIFY MAINTENA KIT is protected by twenty-one US patents.
Patents protecting ABILIFY MAINTENA KIT
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR 1 DISORDER
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Controlled release sterile injectable aripiprazole formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Controlled release sterile injectable aripiprazole formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA
Controlled release sterile injectable aripiprazole formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA
Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Controlled release sterile injectable aripiprazole formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION
Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Method of treating cognitive impairments and schizophrenias
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA
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 MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ABILIFY MAINTENA KIT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | See Plans and Pricing | See Plans and Pricing |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | See Plans and Pricing | See Plans and Pricing |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | See Plans and Pricing | See Plans and Pricing |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ABILIFY MAINTENA KIT
See the table below for patents covering ABILIFY MAINTENA KIT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 106420627 | See Plans and Pricing | |
Hong Kong | 1092808 | See Plans and Pricing | |
Brazil | PI0415531 | método e formulação de aripiprazol injetável estável estéril de liberação controlada | See Plans and Pricing |
Ukraine | 84923 | КРИСТАЛЛИЧЕСКИЙ БЕЗВОДНЫЙ АРИПИПРАЗОЛ G, СПОСОБ ЕГО ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ АРИПИПРАЗОЛ G, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ;КРИСТАЛІЧНИЙ БЕЗВОДНИЙ АРИПІПРАЗОЛ G, СПОСІБ ЙОГО ОДЕРЖАННЯ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ АРИПІПРАЗОЛ G, ТА СПОСІБ ЇЇ ОДЕРЖАННЯ (CRYSTAL ANHYDROUS ARYPIPRASOLE G, A METHOD FOR ITS OBTAINING, PHARMACEUTICAL COMPOSITIONS, CONTAINING ARYPIPRASOLE G, AND METHOD FOR ITS OBTAINING) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ABILIFY MAINTENA KIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0367141 | C00367141/01 | Switzerland | See Plans and Pricing | FORMER REPRESENTATIVE: BOHEST AG, CH |
1675573 | 2014C/029 | Belgium | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
0367141 | SPC/GB04/039 | United Kingdom | See Plans and Pricing | 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 | 300669 | Netherlands | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |