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

Summary for Noden Pharma

International Patents:	210
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 HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		RX	Yes	Yes	5,559,111*PED				Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007		RX	Yes	Yes	8,617,595*PED				Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	CAPSULE, PELLET;ORAL	210709-001	Nov 14, 2017		DISCN	Yes	No
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	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 HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008	5,559,111*PED
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	022107-004	Jan 18, 2008	5,559,111*PED
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	5,559,111*PED

Paragraph IV (Patent) Challenges for NODEN PHARMA drugs

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

International Patents for Noden Pharma Drugs

Country	Document Number	Estimated Expiration
South Korea	20110063596
Austria	317692
Norway	2007011
Malaysia	144477

Supplementary Protection Certificates for Noden Pharma Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
373	Luxembourg		91373, EXPIRES: 20200407
09/010	Ireland		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
2009 00010	Denmark		PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028
C0063	France		PRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Noden Pharma