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Last Updated: August 3, 2020

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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. Three suppliers are listed for this compound.

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 200045-003 Dec 21, 2010 DISCN No No   Start Trial   Start Trial Y   Start Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-001 Sep 16, 2009 DISCN No No   Start Trial   Start Trial Y   Start Trial
>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   Start Trial   Start Trial
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-002 Mar 5, 2007   Start Trial   Start Trial
>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
2305232 122019000098 Germany   Start Trial PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116
2305232 301005 Netherlands   Start Trial 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 C300499 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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