Takeda Company Profile

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

TAKEDA has forty-four approved drugs.

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

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

Summary for Takeda

International Patents:	1429
US Patents:	106
Tradenames:	48
Ingredients:	35
NDAs:	44
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 Na	PREVACID IV	lansoprazole	INJECTABLE;INTRAVENOUS	021566-001	May 27, 2004		DISCN	Yes	No
Takeda Pharms Usa	MOTEGRITY	prucalopride succinate	TABLET;ORAL	210166-001	Dec 14, 2018		RX	Yes	No
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		DISCN	Yes	No	7,959,946		Y
Takeda Pharms Usa	ADDERALL XR 25	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-004	May 22, 2002	AB1	RX	Yes	No
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	AB	RX	Yes	Yes
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes	9,125,909*PED				Y

Expired US Patents for Takeda

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001	5,045,321*PED
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013	5,965,584
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-001	Jun 20, 2017	RE42096
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002	6,322,819*PED
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013	6,166,042
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-007	Mar 27, 2012	7,919,118

Paragraph IV (Patent) Challenges for TAKEDA drugs

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

International Patents for Takeda Drugs

Country	Patent Number	Estimated Expiration
Norway	340294
Eurasian Patent Organization	200601269
World Intellectual Property Organization (WIPO)	2008093878
Japan	2018030873
Lithuania	C2300013
Iceland	8167

Supplementary Protection Certificates for Takeda Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0861666	07C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
2498758	16/2020	Austria		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113
1973545	CA 2013 00066	Denmark		PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1644019	122013000079	Germany		PRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; REGISTRATION NO/DATE: 86155.00.00 86156.00.00 86157.00.00 20130318; FIRST REGISTRATION: UK PL 08081/0050-2 20130201
1973545	92327	Luxembourg		PRODUCT NAME: PONATINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE

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