NODEN PHARMA Company Profile

What is the competitive landscape for NODEN PHARMA, and what generic alternatives to NODEN PHARMA drugs are available?

NODEN PHARMA has four approved drugs.

There are fourteen US patents protecting NODEN PHARMA drugs.

There are seventy-two patent family members on NODEN PHARMA drugs in twenty-six countries and thirty-nine supplementary protection certificates in fourteen countries.

Summary for NODEN PHARMA

International Patents:	72
US Patents:	14
Tradenames:	3
Ingredients:	3
NDAs:	4

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		DISCN	Yes	No	8,618,172		Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	AB	RX	Yes	Yes	8,617,595*PED				Y
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,894,012
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,933,060

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	022107-004	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 HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008	5,559,111*PED
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008	9,023,893

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
World Intellectual Property Organization (WIPO)	2005089729
South Korea	101353736
Japan	2007529456
European Patent Office	1729736

Supplementary Protection Certificates for NODEN PHARMA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
0678503	C00678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
0678503	SPC/GB07/060	United Kingdom		PRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822
2305232	132019000000150	Italy		PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E IDROCLOROTIAZIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/491, 20090120

Similar Applicant Names

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

• Noden Pharma