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Last Updated: September 21, 2021

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Aliskiren hemifumarate - Generic Drug Details

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

Aliskiren hemifumarate is the generic ingredient in six branded drugs marketed by Noden Pharma, Anchen Pharms, and Novartis, and is included in seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate has forty-one patent family members in twenty-three countries.

There are four drug master file entries for aliskiren hemifumarate. Four suppliers are listed for this compound.

Summary for aliskiren hemifumarate
Pharmacology for aliskiren hemifumarate
Drug ClassRenin Inhibitor
Mechanism of ActionRenin Inhibitors
Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE
Tradename Dosage Ingredient NDA Submissiondate
TEKTURNA TABLET;ORAL aliskiren hemifumarate 021985 2014-01-27

US Patents and Regulatory Information for aliskiren hemifumarate

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 200045-004 Dec 21, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-001 Mar 5, 2007 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-003 Dec 21, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-001 Dec 21, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-001 Mar 5, 2007 ⤷  Try it Free ⤷  Try it Free
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-002 Mar 5, 2007 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for aliskiren hemifumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0678503 C300499 Netherlands ⤷  Try it Free PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
2305232 C201930070 Spain ⤷  Try it Free PRODUCT NAME: ALISKIREN HEMIFUMARATO + HIDROCLOROTIAZIDA; NATIONAL AUTHORISATION NUMBER: EU/1/08/491/001-080; DATE OF AUTHORISATION: 20090116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/08/491/001-080; DATE OF FIRST AUTHORISATION IN EEA: 20090116
1602370 SPC/GB09/024 United Kingdom ⤷  Try it Free PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
1507558 C01507558/01 Switzerland ⤷  Try it Free PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011
0678503 07C0055 France ⤷  Try it Free PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
McKinsey
Express Scripts
Moodys
Mallinckrodt

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