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Last Updated: December 10, 2019

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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 eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate has one hundred and six patent family members in thirty-four countries.

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

Recent Litigation for aliskiren hemifumarate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Noden Pharma DAC v. Anchen Pharmaceuticals, Inc.2017-06-12

See all aliskiren hemifumarate litigation

Pharmacology for aliskiren hemifumarate
Drug ClassRenin Inhibitor
Mechanism of ActionRenin Inhibitors
Synonyms for aliskiren hemifumarate
(?S,?S,?S,?S)-?-Amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-?-hydroxy-4-methoxy-3-(3-methoxypropoxy)-?,?-bis(1-methylethyl)benzeneoctanamide hemifumarate
(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxo-propyl)-4-hydroxy-2-isopropyl-7-[[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl]-8-methyl-nonanamide; fumaric acid
(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonanamide hemifumarate
(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-[[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl]-8-methyl-2-propan-2-ylnonanamide; (E)-but-2-enedioic acid
173334-58-2
2C30H53N3O6.C4H4O4
AB0009979
ABP000691
AC1OCFF2
AK174311
AKOS015896419
Aliskiren (hemifumarate)
Aliskiren fumarate
Aliskiren fumarate (JAN/USAN)
Aliskiren fumarate [USAN:JAN]
Aliskiren hemifumarate/
AN-6892
AT-45505
Benzeneoctanamide, delta-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-gamma-hydroxy-4-methoxy-3-(3-methoxypropoxy)-alpha,zeta-bis(1-methylethyl)-, (alphaS,gammaS,deltaS,zetaS)-, (2E)-2-butenedioate (2:1) (salt)
bis((2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonanamide) fumarate
Bis(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methyl-2-(1-methylethyl)nonanamide) (2E)-but-2-enedioate
bis{(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-[4-methoxy-3-(3-methoxypropoxy)benzyl]-8-methyl-2-(propan-2-yl)nonanamide} (2E)-but-2-enedioate
C8A0P8G029
CGP 60536
CGP-60536
CGP-60536B
CHEBI:53777
CHEMBL3545059
CS-0729
D06412
EN300-122378
Enviage
fumaric acid; bis(tekturna)
HY-12177
I06-2020
J10437
KB-47181
KLRSDBSKUSSCGU-KRQUFFFQSA-N
KS-1395
MolPort-008-155-823
Riprazo
SCHEMBL187762
SPP-100
SPP-100B
Sprimeo
SW222231-1
Tekturna (TN)
UNII-C8A0P8G029
W-5448
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 200045-002 Dec 21, 2010 DISCN No No   Start Trial   Start Trial Y   Start Trial
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-005 Dec 21, 2010 DISCN No No   Start Trial   Start Trial Y   Start Trial
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-002 Mar 5, 2007 AB RX Yes Yes   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
0678503 SPC041/2007 Ireland   Start Trial SPC041/2007: 20080416, EXPIRES: 20200406
0678503 C00678503/02 Switzerland   Start Trial PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
1915993 92315 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Johnson and Johnson
Baxter
Boehringer Ingelheim
McKinsey

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