OTSUKA Company Profile

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OTSUKA has seventeen approved drugs.

There are fifty-six US patents protecting OTSUKA drugs.

There are one thousand and seventeen patent family members on OTSUKA drugs in fifty-four countries and forty-nine supplementary protection certificates in sixteen countries.

International Patents:	1017
US Patents:	56
Tradenames:	15
Ingredients:	10
NDAs:	17
Patent Litigation for OTSUKA:	See patent lawsuits for OTSUKA

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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	aripiprazole	INJECTABLE;INTRAMUSCULAR	021866-001	Sep 20, 2006		DISCN	No	No	7,550,445*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004		DISCN	Yes	No	8,759,350	⤷ Try a Trial				⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017		RX	Yes	No	8,547,248	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		RX	Yes	No	8,945,005	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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;INTRAMUSCULAR	202971-004	Sep 29, 2014	5,006,528*PED	⤷ Try a Trial
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-004	Jun 7, 2006	8,642,760*PED	⤷ Try a Trial
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006	9,089,567	⤷ Try a Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-003	Nov 15, 2002	9,387,182	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg	➤ Subscribe	2006-11-15
➤ Subscribe	Tablets	15 mg and 30 mg	➤ Subscribe	2013-09-23
➤ Subscribe	Injection	6 mg/mL	➤ Subscribe	2012-12-26
➤ Subscribe	Oral Solution	1 mg/mL	➤ Subscribe	2007-12-20
➤ Subscribe	Orally Disintegrating Tablets	10 mg, 15 mg, 20 mg and 30 mg	➤ Subscribe	2006-11-15
➤ Subscribe	Tablets	60 mg	➤ Subscribe	2018-03-26

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	C300669	Netherlands	⤷ Try a Trial	PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	PA2014020	Lithuania	⤷ Try a Trial	PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	239 5013-2014	Slovakia	⤷ Try a Trial	PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
2207786	PA2023539	Lithuania	⤷ Try a Trial	PRODUCT NAME: KOMPOZICIJA, APIMANTI: CEDAZURIDINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; IR DECITABINAS; REGISTRATION NO/DATE: EU/1/23/1756 20230915
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.