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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 twenty-one approved drugs.

There are eighty-three US patents protecting TAKEDA drugs.

There are one thousand and sixty patent family members on TAKEDA drugs in fifty-eight countries and ninety-eight supplementary protection certificates in fifteen countries.

Summary for TAKEDA

International Patents:	1060
US Patents:	83
Tradenames:	22
Ingredients:	16
NDAs:	21
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	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009		RX	Yes	No	9,011,926		Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013		RX	Yes	No	7,807,689		Y	Y
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001		DISCN	No	No
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012		DISCN	No	No	7,528,104		Y	Y

Expired US Patents for TAKEDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005	6,172,090
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009	8,475,841
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	6,271,243
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013	5,965,584

Paragraph IV (Patent) Challenges for TAKEDA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Pellets/Capsul	15 mg and 30 mg		2005-12-05
	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 Capsule	30 mg		2010-11-30
	Tablets	0.6 mg		2011-12-23
	Tablets	6.25 mg, 12.5 mg and 25 mg		2017-01-25
	Tablets	5 mg, 10 mg, 15 mgand 20 mg		2017-10-02
	Delayed-release Orally Disinte	15 mg and 30 mg		2006-12-27
	Tablets	8 mg		2009-07-22
	Capsule	60 mg		2010-08-25
	Extended-release Tablets	15 mg/1000 mg and 30 mg/1000 mg		2011-09-23
	Tablets	40 mg and 80 mg		2013-02-13
	Tablets	12.5 mg/500 mg and 12.5 mg/1000 mg		2017-01-25

Non-Orange Book US Patents for TAKEDA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,303,640	Pharmaceutical composition
8,513,190	Method of regulating glucose metabolism, and reagents related thereto
6,214,848	Pharmaceutical composition
8,592,365	Spacer moiety for poly(ethylene glycol) modified peptide based compounds

International Patents for TAKEDA Drugs

Country	Document Number	Estimated Expiration
South Korea	20090028712
South Korea	20050070039
China	101623274
Argentina	048055

Supplementary Protection Certificates for TAKEDA Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1174135/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
2007 00001	Denmark
2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2010 00015	Denmark		PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421

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