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OTSUKA Company Profile

OTSUKA has sixteen approved drugs.

There are sixty US patents protecting OTSUKA drugs.

There are one thousand and seven patent family members on OTSUKA drugs in sixty-three countries and thirty-four supplementary protection certificates in fifteen countries.

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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	207202-002	Nov 13, 2017		RX	Yes	Yes	9,444,503	Start Trial	Y			Start Trial
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015		RX	Yes	No	8,618,109	Start Trial				Start Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013		RX	Yes	No	10,525,057	Start Trial				Start Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No	9,089,567	Start Trial				Start Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017		RX	Yes	No	9,359,302	Start Trial	Y	Y		Start 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	202971-003	Sep 29, 2014	5,006,528*PED	Start Trial
Otsuka Pharm Co Ltd	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018	5,972,882	Start Trial
Otsuka America	BREATHTEK UBT FOR H-PYLORI	urea c-13	FOR SOLUTION;ORAL	020586-002	May 10, 2001	5,140,993	Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-003	Jun 7, 2006	5,006,528*PED	Start Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013	5,006,528*PED	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	LUC00086	Luxembourg	Start Trial	PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1675573	92427	Luxembourg	Start Trial	PRODUCT NAME: ARIPIPRAZOLE
1675573	PA2014020	Lithuania	Start Trial	PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
0287951	SPC/GB98/016	United Kingdom	Start Trial	PRODUCT NAME: GREPAFLOXACIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT INCLUDING GREPAFLOXACIN HYDROCHLORIDE SESQUIHYDRATE; REGISTERED: DE 40682.00.00 19970731; DE 40682.01.00 19970731; DE 40682.02.00 19970731; UK 10949/0299 19971209; UK 10949/0300 19971209
1869025	1890028-2	Sweden	Start Trial	PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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