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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.
Summary for ARIPIPRAZOLE


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Recent Clinical Trials for ARIPIPRAZOLE
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Sponsor | Phase |
---|---|
Henan Mental Hospital | Phase 2 |
Shanghai Mental Health Center | Phase 2 |
The First Affiliated Hospital of Kunming Medical College | Phase 2 |
Pharmacology for ARIPIPRAZOLE
Drug Class | Atypical Antipsychotic |
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 |