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 eight branded drugs marketed by Xiamen Lp Pharm Co, Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in forty-four NDAs. There are sixty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aripiprazole has nine hundred and one patent family members in forty-eight countries.

There are forty-nine drug master file entries for aripiprazole. Forty-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for aripiprazole

International Patents:	901
US Patents:	63
Tradenames:	8
Applicants:	31
NDAs:	44
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	161
Clinical Trials:	385
Patent Applications:	5,831
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

See drug prices for aripiprazole

Drug Sales Revenue Trends for aripiprazole

See drug sales revenues for aripiprazole

Recent Clinical Trials for aripiprazole

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

Sponsor	Phase
Instituto de Salud Carlos III	Phase 4
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 4
First Affiliated Hospital Xi'an Jiaotong University	N/A

See all aripiprazole clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	30MG	TABLET; ORALLY DISINTEGRATING
⤷ Sign Up	⤷ Sign Up	20MG	TABLET, ORALLY DISINTEGRATING; ORAL
⤷ Sign Up	⤷ Sign Up	15MG	TABLET, ORALLY DISINTEGRATING; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for aripiprazole

Drug Class	Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for aripiprazole

Antipsychotic Agents

Anatomical Therapeutic Chemical (ATC) Classes for aripiprazole

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	Nov 15, 2002	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for aripiprazole

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)	aripiprazole	EMEA/H/C/003803 Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.	Authorised	yes	no	no	2015-06-30
Otsuka Pharmaceutical Netherlands B.V.	Abilify	aripiprazole	EMEA/H/C/000471 Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.	Authorised	no	no	no	2004-06-04
Otsuka Pharmaceutical Netherlands B.V.	Abilify Maintena	aripiprazole	EMEA/H/C/002755 Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.	Authorised	no	no	no	2013-11-14
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for aripiprazole

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Country	Patent Number	Title	Estimated Expiration
Argentina	090776	PREPARACION INYECTABLE, Y JERINGA PRELLENADA QUE CONTIENE LA PREPARACION INYECTABLE	⤷ Sign Up
Hong Kong	1129889		⤷ Sign Up
China	106420627		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for aripiprazole

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	239 5013-2014	Slovakia	⤷ Sign Up	PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
1675573	2014C/029	Belgium	⤷ Sign Up	PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573	32/2014	Austria	⤷ Sign Up	PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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