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Last Updated: November 21, 2024

Aliskiren hemifumarate; amlodipine besylate - Generic Drug Details


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

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

Aliskiren hemifumarate; amlodipine besylate has twenty-three patent family members in twenty-one countries.

Summary for aliskiren hemifumarate; amlodipine besylate
International Patents:23
US Patents:1
Tradenames:2
Applicants:1
NDAs:2
DailyMed Link:aliskiren hemifumarate; amlodipine besylate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aliskiren hemifumarate; amlodipine besylate
Generic Entry Date for aliskiren hemifumarate; amlodipine besylate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for aliskiren hemifumarate; amlodipine besylate

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 200045-005 Dec 21, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-002 Dec 21, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-004 Dec 21, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-003 Aug 26, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for aliskiren hemifumarate; amlodipine besylate

Country Patent Number Title Estimated Expiration
European Patent Office 2328564 FORMULATIONS GALÉNIQUES DE COMPOSÉS ORGANIQUES (FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE) ⤷  Sign Up
Ecuador SP11010999 COMBINACIÓN DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE DOS CAPAS O DE UNA SOLA CAPA DE ALISQUIRENO Y AMLODIPINA ⤷  Sign Up
Chile 2011000594 Combinacion farmaceutica que comprende: a) 10-45% de alisquireno, b) 0,5-5% de amlodipina, c) 2-15% de un desintegrante, d) 1-60% de un diluyente, e) 0,1-20% de un aglutinante, f) 0,1-5% de un lubricante, g) 0,05-5% de un derrapante y h) opcionalmente un relleno; metodo de preparacion; uso para tratar hipertension. ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1915993 13C0063 France ⤷  Sign Up 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
1915993 122013000093 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION UMFASSEND ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/686/001 - 056 20110414
1915993 C300625 Netherlands ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.