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Last Updated: November 30, 2022

Aliskiren hemifumarate - Generic Drug Details


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

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 six 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 Action Renin Inhibitors
Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TEKTURNA Tablets aliskiren hemifumarate 150 mg and 300 mg 021985 1 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 200045-005 Dec 21, 2010 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Anchen Pharms ALISKIREN HEMIFUMARATE aliskiren hemifumarate TABLET;ORAL 206665-001 Mar 22, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-002 Mar 5, 2007 AB RX Yes Yes 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-001 Mar 5, 2007 See Plans and Pricing See Plans and Pricing
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-002 Mar 5, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for aliskiren hemifumarate

Country Patent Number Title Estimated Expiration
European Patent Office 2283826 Formulations galéniques de composés organiques (GALENIC FORMULATIONS OF ORGANIC COMPOUNDS) See Plans and Pricing
South Africa 200606220 GALENIC FORMULATIONS OF ORGANIC COMPOUNDS See Plans and Pricing
Morocco 28490 FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES See Plans and Pricing
Brazil PI0508833 formulações galênicas de compostos orgánicos See Plans and Pricing
Singapore 153830 GALENIC FORMULATIONS OF ORGANIC COMPOUNDS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aliskiren hemifumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0678503 07C0055 France See Plans and Pricing PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
1507558 CR 2012 00018 Denmark See Plans and Pricing PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
0678503 C300499 Netherlands See Plans and Pricing 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
1915993 C300625 Netherlands See Plans and Pricing 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
1602370 11/2009 Austria See Plans and Pricing PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Express Scripts
Dow
Merck
Johnson and Johnson

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.