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Last Updated: June 17, 2021

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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 patent protection?

Aliskiren hemifumarate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Noden Pharma and is included in one NDA. There are two 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 twenty-five patent family members in thirty-nine countries.

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

Pharmacology for aliskiren hemifumarate; hydrochlorothiazide
Drug ClassRenin Inhibitor
Thiazide Diuretic
Mechanism of ActionRenin Inhibitors
Physiological EffectIncreased Diuresis
Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Tradename Dosage Ingredient NDA Submissiondate
TEKTURNA HCT TABLET;ORAL aliskiren hemifumarate; hydrochlorothiazide 022107 2014-03-07

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 022107-003 Jan 18, 2008 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for aliskiren hemifumarate; hydrochlorothiazide

Supplementary Protection Certificates for aliskiren hemifumarate; hydrochlorothiazide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1602370 2009/010 Ireland   Try Before You Buy 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
2305232 132019000000150 Italy   Try Before You Buy 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
2305232 301005 Netherlands   Try Before You Buy PRODUCT NAME: ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/08/491 20090120
0678503 C300386 Netherlands   Try Before You Buy PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028
2305232 122019000098 Germany   Try Before You Buy PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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