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 Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014		RX	Yes	No	11,154,553	⤷ Try a Trial				⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		RX	Yes	No	9,149,577	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No	8,114,021	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No	11,097,007	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-002	Nov 15, 2002	AB	RX	Yes	No	9,125,939	⤷ Try a Trial				⤷ Try a Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	No	11,154,553	⤷ Try a Trial				⤷ Try a Trial
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-004	Jul 10, 2015	AB	RX	Yes	Yes	7,888,362	⤷ Try a Trial		Y	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	ABILIFY	aripiprazole	TABLET;ORAL	021436-001	Nov 15, 2002	8,642,760*PED	⤷ Try a Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013	8,759,351	⤷ Try a Trial
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-004	Jun 7, 2006	9,359,302	⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017	8,642,760	⤷ Try a Trial
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004	5,006,528*PED	⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017	9,359,302	⤷ Try a Trial
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006	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
0450097	09C0049	France	⤷ Try a Trial	PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
2207786	CA 2023 00037	Denmark	⤷ Try a Trial	PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918
2207786	LUC00326	Luxembourg	⤷ Try a Trial	PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913
2207786	PA2023538	Lithuania	⤷ Try a Trial	PRODUCT NAME: CEDAZURIDINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1756 20230915
1869025	CR 2018 00028	Denmark	⤷ Try a Trial	PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1675573	C20140014 00322	Estonia	⤷ Try a Trial	PRODUCT NAME: ARIPIPRASOOL;REG NO/DATE: K(2013)8163 (LOPLIK) 19.11.2013
0451216	99C0028	Belgium	⤷ Try a Trial	PRODUCT NAME: GREPAFLOXACINE; CHLORHYDRATE SESQUIHYDRATE; NAT. REGISTRATION NO/DATE: NL 23 373 19990525; FIRST REGISTRATION: DE - 4062.00.00 19970731
>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.