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Noden Pharma Company Profile

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What is the competitive landscape for NODEN PHARMA, and when can generic versions of NODEN PHARMA drugs launch?

NODEN PHARMA has three approved drugs.

There are four US patents protecting NODEN PHARMA drugs.

There are two hundred and seventeen patent family members on NODEN PHARMA drugs in forty-one countries and forty-two supplementary protection certificates in twelve countries.

Summary for Noden Pharma

International Patents:	217
US Patents:	4
Tradenames:	2
Ingredients:	2
NDAs:	3
Patent Litigation for Noden Pharma:	See patent lawsuits for Noden Pharma

Drugs and US Patents for Noden Pharma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	AB	RX	Yes	Yes	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		RX	Yes	Yes	5,559,111*PED
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		RX	Yes	Yes	8,618,172		Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		RX	Yes	Yes	9,023,893		Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		RX	Yes	No	8,618,172		Y

Expired US Patents for Noden Pharma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008	5,559,111*PED
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008	5,559,111*PED

Paragraph IV (Patent) Challenges for NODEN PHARMA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg		2014-03-07
	Tablets	150 mg and 300 mg		2013-12-13

International Patents for Noden Pharma Drugs

Country	Patent Number	Estimated Expiration
Slovenia	1602370
Japan	2018030894
Denmark	0678503
Denmark	1602370
Russian Federation	2006132668
Mexico	2008016533

Supplementary Protection Certificates for Noden Pharma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	C00678503/02	Switzerland		PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
0678503	CA 2011 00027	Denmark
1602370	SPC/GB09/024	United Kingdom		PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
0678503	07C0055	France		PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
0678503	91373	Luxembourg		91373, EXPIRES: 20200407
1602370	C300385	Netherlands		PRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028

Similar Applicant Names

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Here is a list of applicants with similar names.

• Noden Pharma