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 MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		RX	Yes	No	8,017,615	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		RX	Yes	No	10,441,194	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No	8,547,248	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	No	7,807,680	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017		RX	Yes	No	10,441,194	⤷ Try a Trial	Y			⤷ Try a Trial
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-004	Jul 10, 2015	AB	RX	Yes	Yes		⤷ Try a Trial				⤷ 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
>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
0287951	C980011	Netherlands	⤷ Try a Trial	PRODUCT NAME: GREPAFLOXACINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AA NVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN ALKANOL MET 1-6 KOOLSTOFATOMEN, IN HET BIJZONDER GREPAFLOXACINI HYDROCHLOR IDUM SESQUIHYDRATUM; NAT. REGISTRATION NO/DATE: RVG 21894, RVG 21895 19971113; FIRST REGISTRATION: DE 40682.00.00, 40682.01.00, 40682.02.00 19970731
2207786	301257	Netherlands	⤷ Try a Trial	PRODUCT NAME: SAMENSTELLING WELKE OMVAT: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918
1869025	1890028-2	Sweden	⤷ Try a Trial	PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
1869025	32/2018	Austria	⤷ Try a Trial	PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727
1869025	2018/034	Ireland	⤷ Try a Trial	PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1294 20180726; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2402)
1869025	LUC00086	Luxembourg	⤷ Try a Trial	PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
>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.