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Generated: February 16, 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-one 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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for aliskiren hemifumarate; hydrochlorothiazide

Country Document Number Estimated Expiration
Norway 2007011 ➤ Try a Free Trial
Russian Federation 2009101971 ➤ Try a Free Trial
Portugal 1602370 ➤ Try a Free Trial
Cyprus 2208 ➤ Try a Free Trial
Austria 397445 ➤ Try a Free Trial
China 101472566 ➤ Try a Free Trial
Norway 2013019 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for aliskiren hemifumarate; hydrochlorothiazide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
373 Luxembourg ➤ Try a Free Trial 91373, EXPIRES: 20200407
09/010 Ireland ➤ Try a Free Trial 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 ➤ Try a Free Trial 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 ➤ Try a Free Trial 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
2007 00049 Denmark ➤ Try a Free Trial
0625 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
C041/2007 Ireland ➤ Try a Free Trial SPC041/2007: 20080416, EXPIRES: 20200406
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

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Accenture
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