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Aripiprazole - Generic Drug Details

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Aripiprazole is the generic ingredient in four branded drugs marketed by Alembic Pharms Ltd, Amneal Pharms, Teva Pharms Usa, Aurobindo Pharma Ltd, Otsuka, Torrent Pharms Ltd, Hetero Labs Ltd V, Otsuka Pharm Co Ltd, Silarx Pharms Inc, Ajanta Pharma Ltd, Apotex Inc, and Alkermes Inc, and is included in twenty NDAs. There are twenty-seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and thirty-five patent family members in fifty countries.

There are forty-one drug master file entries for aripiprazole. Thirty-three suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: aripiprazole

Tradenames:4
Patents:27
Applicants:12
NDAs:20
Drug Master File Entries: see list41
Suppliers / Packaging: see list33
Therapeutic Class:Antipsychotics
Bipolar Agents
Drug Prices:see low prices

Pharmacology for Ingredient: aripiprazole

Tentative approvals for ARIPIPRAZOLE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL10MG
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL15MG
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL20MG

Clinical Trials for: aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYes8,030,313Oct 19, 2024
Ajanta Pharma Ltd
ARIPIPRAZOLE
aripiprazole
TABLET;ORAL206174-005Sep 12, 2016RXNo
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-005Nov 15, 2002RXYes8,642,760*PEDMar 25, 2023Y
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Expired Orange Book Patents for Generic Ingredient: aripiprazole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 20145,006,528*PED<disabled>
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 20145,006,528*PED<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 20024,734,416<disabled>
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Non-Orange Book Patents for Generic Ingredient: aripiprazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,999,952Aripiprazole complex formulation and method<disabled in preview>
8,952,013Controlled release sterile injectable aripiprazole formulation and method<disabled in preview>
8,623,874Method of treating neurodegenerative diseases<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: aripiprazole

Country Document Number Estimated Expiration
New Zealand545037<disabled in preview>
Slovenia1927356<disabled in preview>
Cyprus1109040<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ARIPIPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00669Netherlands<disabled>PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0669Netherlands<disabled>PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573/01Switzerland<disabled>PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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