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Last Updated: May 21, 2022

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide - Generic Drug Details


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What are the generic drug sources for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide and what is the scope of patent protection?

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide has thirty-two patent family members in twenty-four countries.

Summary for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
International Patents:32
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide at DailyMed

US Patents and Regulatory Information for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-003 Dec 21, 2010 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-001 Dec 21, 2010 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-004 Dec 21, 2010 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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; amlodipine besylate; hydrochlorothiazide

International Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Country Patent Number Title Estimated Expiration
Poland 219032 See Plans and Pricing
Norway 20045459 See Plans and Pricing
European Patent Office 2316488 Composition pharmaceutique comprenant un inhibiteur de rénine, un agent de blocage du canal du calcium et un diurétique (Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 122012000031 Germany See Plans and Pricing PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705
1507558 113 5008-2012 Slovakia See Plans and Pricing PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705
1602370 09C0020 France See Plans and Pricing PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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