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 thirty 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:	1430
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 Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-001	Mar 27, 2012		DISCN	No	No	7,528,104		Y	Y
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-006	Mar 27, 2012		DISCN	No	No	7,084,245		Y	Y
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	8,093,296
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	AB	RX	Yes	No	7,465,465		Y
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	7,619,004
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	7,915,269

Expired US Patents for TAKEDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	5,912,013
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	5,965,584
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	6,617,317
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	5,045,321*PED
Takeda Pharms Usa	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001	6,322,819*PED
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013	7,078,381

Paragraph IV (Patent) Challenges for TAKEDA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for TAKEDA Drugs

Country	Patent Number	Estimated Expiration
Japan	5330967
South Korea	20110043599
Eurasian Patent Organization	201500430
Japan	2011503113
South Korea	100770194
Mexico	PA06004639

Supplementary Protection Certificates for TAKEDA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C 2014 029	Romania		PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2300013	132019000000069	Italy		PRODUCT NAME: BRIGATINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ALUNBRIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1264, 20181126
2178888	C 2017 012	Romania		PRODUCT NAME: IXAZOMIB SI SARURI SI ESTERI AI ACESTUIA ACCEPTABILE FARMACEUTIC, CA CITRAT DE IXAZOMIB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1094; DATE OF NATIONAL AUTHORISATION: 20161121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1094; DATE OF FIRST AUTHORISATION IN EEA: 20161121
0174726	93C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
1261586	1290013-0	Sweden		PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210

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