Noden Pharma Company Profile

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 three US patents protecting NODEN PHARMA drugs.

There are one hundred and fifty-seven patent family members on NODEN PHARMA drugs in thirty-nine countries and forty-one supplementary protection certificates in fourteen countries.

Summary for Noden Pharma

International Patents:	157
US Patents:	3
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	022107-002	Jan 18, 2008		DISCN	Yes	No	8,618,172		Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		RX	Yes	Yes	9,023,893		Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		RX	Yes	Yes	8,618,172		Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No	8,617,595*PED				Y
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

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	022107-002	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	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	9,023,893
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	9,023,893

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	Patent Number	Estimated Expiration
Austria	317692
Germany	60117295
South Africa	200303497
Poland	400915
European Patent Office	1915993
Ecuador	SP066807

Supplementary Protection Certificates for Noden Pharma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	1390055-0	Sweden		PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414
0678503	07C0055	France		PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
1602370	132009901728448	Italy		PRODUCT NAME: (ALISKIREN EMIFUMARATO/IDROCLOROTIAZIDE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/08/491/001 A EU/1/08/491/080, 20090116
1602370	2009/010	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
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
1507558	18/2012	Austria		PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - 060 20111122; FIRST REGISTRATION: LI 61678 01-61678 05 20110705

Similar Applicant Names

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

• Noden Pharma