TAKEDA PHARMS USA Company Profile

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

TAKEDA PHARMS USA has forty approved drugs.

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

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

Summary for TAKEDA PHARMS USA

International Patents:	1430
US Patents:	106
Tradenames:	43
Ingredients:	33
NDAs:	40

Drugs and US Patents for TAKEDA PHARMS USA

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	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes	11,046,674
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes	9,125,908*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150-001	Aug 25, 2011	AP	RX	Yes	Yes
Takeda Pharms Usa	ADDERALL XR 30	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-003	Oct 11, 2001	AB1	RX	Yes	Yes
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes	8,173,158*PED				Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		DISCN	Yes	No	7,785,627		Y

Expired US Patents for TAKEDA PHARMS USA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999	6,166,042
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009	8,470,368
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	6,287,599*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	5,045,321*PED
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	4,689,333
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	5,045,321*PED
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013	6,303,661

Paragraph IV (Patent) Challenges for TAKEDA PHARMS USA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for TAKEDA PHARMS USA Drugs

Country	Patent Number	Estimated Expiration
Brazil	PI0411155
Japan	4896719
Israel	195511
Singapore	145765
Colombia	6160301
Montenegro	03334
Hungary	S1700018

Supplementary Protection Certificates for TAKEDA PHARMS USA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	C300652	Netherlands		PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271	PA2014013,C1436271	Lithuania		PRODUCT NAME: VORTIOKSETINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA RUGSTIES PRISIJUNGIMO DRUSKA; REGISTRATION NO/DATE: EU/1/13/891 20131218
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1020454	SPC/GB10/019	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/019 GRANTED TO TEIJIN LIMITED IN RESPECT OF THE PRODUCT FEBUXOSTAT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6408 DATED 14/03/2012 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/04/2023.
3157916	C03157916/01	Switzerland		PRODUCT NAME: MOBOCERTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68147 01.06.2022
1084705	CR 2014 00066	Denmark		PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116

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