OTSUKA Company Profile

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OTSUKA has seventeen approved drugs.

There are fifty-eight US patents protecting OTSUKA drugs.

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

International Patents:	1030
US Patents:	58
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 MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No	10,517,507	⤷ Subscribe	Y			⤷ Subscribe
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		RX	Yes	No	8,956,288	⤷ Subscribe	Y			⤷ Subscribe
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014		RX	Yes	No	8,338,427	⤷ Subscribe	Y			⤷ Subscribe
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-001	Jul 10, 2015		RX	Yes	No	8,349,840*PED	⤷ Subscribe			Y	⤷ Subscribe
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	No	8,338,427	⤷ Subscribe	Y			⤷ Subscribe
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes	11,097,007	⤷ Subscribe	Y			⤷ Subscribe
>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	8,759,351	⤷ Subscribe
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023	8,338,428	⤷ Subscribe
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-004	Jun 7, 2006	8,518,421*PED	⤷ Subscribe
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-005	Jun 7, 2006	5,006,528*PED	⤷ Subscribe
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017	8,580,796	⤷ Subscribe
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-005	Jun 7, 2006	8,017,615*PED	⤷ Subscribe
>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	CA 2018 00028	Denmark	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	PA2018509	Lithuania	⤷ Subscribe	PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
2207786	CR 2023 00038	Denmark	⤷ Subscribe	PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918
1869025	122018000088	Germany	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
2207786	CA 2023 00037	Denmark	⤷ Subscribe	PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918
1869025	300946	Netherlands	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOLE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/18/1294 20180727
>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.