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Noden Pharma Company Profile

NODEN PHARMA has three approved drugs.

There are four US patents protecting NODEN PHARMA drugs.

There are two hundred and ten patent family members on NODEN PHARMA drugs in forty-one countries and thirty-nine supplementary protection certificates in eleven countries.

International Patents:	210
US Patents:	4
Tradenames:	2
Ingredients:	2
NDAs:	3
Patent Litigation for Noden Pharma:	See patent lawsuits for Noden Pharma

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

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

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2013 00062	Denmark	➤ Sign Up	PRODUCT NAME: KOMBINATION OMFATTENDE ALISKIREN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HEMIFUMARAT, OG AMLODIPIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BENSYLAT; REG. NO/DATE: EU/1/11/686/001/056 20110418
315	Luxembourg	➤ Sign Up	PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
00625	Netherlands	➤ Sign Up	PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
09/010	Ireland	➤ Sign Up	PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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