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Takeda Pharms Usa Company Profile

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What is the competitive landscape for TAKEDA PHARMS USA, and when can generic versions of TAKEDA PHARMS USA drugs launch?

TAKEDA PHARMS USA has seventeen approved drugs.

There are eighty-five US patents protecting TAKEDA PHARMS USA drugs.

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

Summary for Takeda Pharms Usa

International Patents:	1054
US Patents:	85
Tradenames:	17
Ingredients:	14
NDAs:	17

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	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012		DISCN	No	No	7,919,118		Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No	9,125,908
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No

Expired US Patents for Takeda Pharms Usa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PREVPAC	amoxicillin; clarithromycin; lansoprazole	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	050757-001	Dec 2, 1997	5,093,132*PED
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999	6,166,043
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013	6,166,043
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013	6,172,090

Paragraph IV (Patent) Challenges for TAKEDA PHARMS USA 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 Pharms Usa

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
6,080,765	Pharmaceutical composition
8,318,669	Method of regulating glucose metabolism, and reagents related thereto
9,044,424	Methods of regulating glucose metabolism, and reagents related thereto
6,211,207	Pharmaceutical composition

International Patents for Takeda Pharms Usa Drugs

Country	Document Number	Estimated Expiration
Slovakia	283970
Taiwan	200848411
Taiwan	I443091
China	1681496

Supplementary Protection Certificates for Takeda Pharms Usa Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90014-6	Sweden		PRODUCT NAME: ALOGLIPTIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/844 20130919
5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
2014 00011	Denmark		PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130919
397	Luxembourg		PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE

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