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TAKEDA Company Profile

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What is the competitive landscape for TAKEDA, and what generic alternatives to TAKEDA drugs are available?

TAKEDA has forty approved drugs.

There are one hundred and seventeen US patents protecting TAKEDA drugs.

There are one thousand five hundred and ninety-nine patent family members on TAKEDA drugs in fifty-eight countries and one hundred and eighty-nine supplementary protection certificates in nineteen countries.

Summary for TAKEDA

International Patents:	1599
US Patents:	117
Tradenames:	44
Ingredients:	31
NDAs:	40
Patent Litigation for TAKEDA:	See patent lawsuits for TAKEDA
PTAB Cases with TAKEDA as patent owner:	See PTAB cases with TAKEDA as patent owner

Drugs and US Patents for TAKEDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-004	Dec 10, 2007		RX	Yes	No	7,671,030*PED				Y
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	AB	RX	Yes	No	6,287,599*PED
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	AB	RX	Yes	Yes	7,700,128		Y
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-007	Oct 30, 2014		RX	Yes	No	7,687,467*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-001	Jan 28, 2017		RX	Yes	No	7,659,253*PED				Y
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-004	Dec 10, 2007		RX	Yes	No	7,687,466*PED				Y

Expired US Patents for TAKEDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	6,462,058*PED
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013	6,271,243
Takeda Pharms Usa	ADDERALL XR 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-001	Oct 11, 2001	RE41148*PED
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	6,166,043
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013	5,965,584
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	5,093,132*PED
Takeda Pharms Usa	ADDERALL XR 25	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-004	May 22, 2002	RE42096*PED

Paragraph IV (Patent) Challenges for TAKEDA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Capsule	30 mg		2010-11-30
	Tablets	5 mg, 10 mg, 15 mgand 20 mg		2017-10-02
	Extended-release Capsules	37.5 mg and50 mg		2017-08-03
	Capsules	20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg		2011-02-23
	Chewable Tablet	500 mg, 750 mg and 1000 mg		2008-10-27
	Delayed-release Tablets	1.2 g		2009-12-16
	Extended-release Tablets	1 mg, 2 mg, 3 mg and 4 mg		2009-12-29
	Tablets	0.6 mg		2011-12-23
	Delayed-release Pellets/Capsul	15 mg and 30 mg		2005-12-05
	Tablets	12.5 mg/500 mg and 12.5 mg/1000 mg		2017-01-25
	Capsule	60 mg		2010-08-25
	Tablets	8 mg		2009-07-22
	Extended-release Capsules	100 mg and 200 mg		2006-02-02
	Tablets	40 mg and 80 mg		2013-02-13
	Extended-release Capsules	12.5 mg and 25 mg		2017-08-07
	For Injection	3.5 mg/vial		2008-11-20
	Oral Powder	750 mg and 1000 mg		2015-11-25
	Extended-release Tablets	15 mg/1000 mg and 30 mg/1000 mg		2011-09-23
	Tablets	15 mg/500 mg and 15 mg/850 mg		2008-03-06
	Tablets	30 mg/2 mg and 30 mg/4 mg		2009-12-22
	Delayed-release Orally Disinte	15 mg and 30 mg		2006-12-27
	Tablets	6.25 mg, 12.5 mg and 25 mg		2017-01-25

International Patents for TAKEDA Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012033941
World Intellectual Property Organization (WIPO)	2006090845
Eurasian Patent Organization	200600479
Iceland	7164
Spain	2410812
Canada	2432178
Cyprus	1109551

Supplementary Protection Certificates for TAKEDA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	2012C/016	Belgium		PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1644019	549	Finland
0193256	SPC/GB01/016	United Kingdom		PRODUCT NAME: PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE HYDROCHLORIDE SALT; REGISTERED: CH IKS 55 378 01 20000927; CH IKS 55 378 02 20000927; CH IKS 55 378 03 20000927; UK EU/1/00/151/001 20001011; UK EU/1/00/151/002 20001011; UK EU/1/00/151/003 20001011; UK EU/1/00/151/004 20001011; UK EU/1/00/151/005 20001011; UK EU/1/00/151/006 20001011
2300013	363 50014-2019	Slovakia		PRODUCT NAME: BRIGATINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1264/001 - EU/1/18/1264/012 20181126
1973545	CR 2013 00066	Denmark		PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701
2300013	1990030-7	Sweden		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1264 20181126

Similar Applicant Names

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

• Takeda
• Takeda Pharms Na
• Takeda Pharms Usa