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Generated: June 17, 2019

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Aliskiren hemifumarate; hydrochlorothiazide - Generic Drug Details

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What are the generic drug sources for aliskiren hemifumarate; hydrochlorothiazide and what is the scope of aliskiren hemifumarate; hydrochlorothiazide freedom to operate?

Aliskiren hemifumarate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Noden Pharma and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; hydrochlorothiazide has one hundred and eighty-six patent family members in forty-one countries.

There are four drug master file entries for aliskiren hemifumarate; hydrochlorothiazide. One supplier is listed for this compound.

Summary for aliskiren hemifumarate; hydrochlorothiazide
Pharmacology for aliskiren hemifumarate; hydrochlorothiazide
Drug ClassRenin Inhibitor
Thiazide Diuretic
Mechanism of ActionRenin Inhibitors
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for aliskiren hemifumarate; hydrochlorothiazide

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 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 RX Yes Yes ➤ Sign Up ➤ 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

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Expired US Patents for aliskiren hemifumarate; hydrochlorothiazide

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 ➤ Sign Up ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 ➤ Sign Up ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 ➤ Sign Up ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for aliskiren hemifumarate; hydrochlorothiazide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1602370 2009/010 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
1915993 2013C/068 Belgium ➤ Sign Up PRODUCT NAME: COMBINAISON COMPRENANT L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET L'AMLOPINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/11/686/001 20110415
1507558 CR 2012 00018 Denmark ➤ Sign Up PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
0678503 91564 Luxembourg ➤ Sign Up 91564, EXPIRES: 20200407
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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