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Last Updated: June 29, 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 200045-002 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 200045-003 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 200045-005 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
Japan 2010280708 PHARMACEUTICAL COMPOSITION CONTAINING RENIN INHIBITOR, CALCIUM CHANNEL BLOCKER, AND EMULGENT See Plans and Pricing
Russian Federation 2316318 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ИНГИБИТОРРЕНИНА, БЛОКАТОР КАЛЬЦИЕВЫХ КАНАЛОВ И ДИУРЕТИК (PHARMACEUTICAL COMPOSITION INCLUDING RENIN INHIBITOR, CALCIUM CHANNEL BLOCKER AND DIURETIC) See Plans and Pricing
Poland 219032 See Plans and Pricing
Japan 5288678 See Plans and Pricing
South Africa 200408442 Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic. See Plans and Pricing
Mexico PA04011383 COMPOSICION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE RENINA, UN BLOQUEADOR DEL CANAL DE CALCIO Y UN DIURETICO. (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 C300528 Netherlands See Plans and Pricing 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
1915993 2013C/068 Belgium See Plans and Pricing 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 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 CA 2012 00018 Denmark See Plans and Pricing
1602370 132009901728448 Italy See Plans and Pricing 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
1507558 1290018-9 Sweden See Plans and Pricing PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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