Aripiprazole - Generic Drug Details
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What are the generic drug sources for aripiprazole and what is the scope of patent protection?
Aripiprazole
is the generic ingredient in six branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Vistapharm, Alembic Pharms Ltd, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in thirty-seven NDAs. There are sixty-five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Aripiprazole has eight hundred and thirty-five patent family members in fifty-two countries.
There are forty-nine drug master file entries for aripiprazole. Forty-six suppliers are listed for this compound.
Summary for aripiprazole
International Patents: | 835 |
US Patents: | 65 |
Tradenames: | 6 |
Applicants: | 24 |
NDAs: | 37 |
Drug Master File Entries: | 49 |
Finished Product Suppliers / Packagers: | 46 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 373 |
Patent Applications: | 5,259 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for aripiprazole |
Drug Sales Revenues: | Drug sales revenues for aripiprazole |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aripiprazole |
What excipients (inactive ingredients) are in aripiprazole? | aripiprazole excipients list |
DailyMed Link: | aripiprazole at DailyMed |
Recent Clinical Trials for aripiprazole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Phase 4 |
Vanderbilt University Medical Center | Phase 4 |
Tan Tock Seng Hospital | Phase 3 |
Pharmacology for aripiprazole
Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for aripiprazole
Anatomical Therapeutic Chemical (ATC) Classes for aripiprazole
Paragraph IV (Patent) Challenges for ARIPIPRAZOLE
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 |
ABILIFY | Oral Solution | aripiprazole | 1 mg/mL | 021713 | 1 | 2007-12-20 |
ABILIFY | Tablets | aripiprazole | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | 021436 | 8 | 2006-11-15 |
ABILIFY | Orally Disintegrating Tablets | aripiprazole | 10 mg, 15 mg, 20 mg and 30 mg | 021729 | 1 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 203908-005 | Oct 8, 2015 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Boscogen | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 091279-004 | Jan 9, 2017 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | 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 aripiprazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | See Plans and Pricing | See Plans and Pricing |
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | See Plans and Pricing | See Plans and Pricing |
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aripiprazole
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2774595 | SYSTÈME INGURGITABLE MARQUEUR D'ÉVÉNEMENT, INTÉGRÉ À UN PRODUIT PHARMACEUTIQUE (INTEGRATED INGESTIBLE EVENT MARKER SYSTEM WITH PHARMACEUTICAL PRODUCT) | See Plans and Pricing |
South Korea | 101898964 | See Plans and Pricing | |
South Korea | 101754803 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aripiprazole
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 92427 | Luxembourg | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOLE |
1675573 | CA 2014 00026 | Denmark | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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