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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

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	022107-004	Jan 18, 2008		RX	Yes	Yes	8,618,172		Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007		RX	Yes	No	5,559,111*PED				Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		RX	Yes	No	5,559,111*PED				Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		RX	Yes	No	8,618,172		Y

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

Non-Orange Book US Patents for Noden Pharma

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
7,683,054	Galenic formulations of organic compounds
5,646,143	.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
5,606,078	3,5-Disubstituted tetrahydrofuran-2-ones
5,705,658	Azido containing tetrahydro furan compounds

International Patents for Noden Pharma Drugs

Country	Document Number	Estimated Expiration
Canada	2147052
Poland	400914
New Zealand	270936
European Patent Office	0678500

Supplementary Protection Certificates for Noden Pharma Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503/02	Switzerland		PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
3 5008-2012	Slovakia		PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705
00499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
12/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705

Similar Applicant Names

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

• Noden Pharma