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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Dow
Harvard Business School
Deloitte
US Army
Medtronic
Federal Trade Commission
Queensland Health
Teva

Generated: July 19, 2018

DrugPatentWatch Database Preview

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide has one hundred and eighty-three patent family members in thirty-five countries.

There are four drug master file entries for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide.
Summary for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
International Patents:183
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
DailyMed Link:ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE at DailyMed

US Patents and Regulatory Information for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-002 Dec 21, 2010 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-004 Dec 21, 2010 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-005 Dec 21, 2010 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones ➤ Sign Up
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Sign Up
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Sign Up
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C041/2007 Ireland ➤ Sign Up SPC041/2007: 20080416, EXPIRES: 20200406
2012 00018 Denmark ➤ Sign Up
2009 00009 Denmark ➤ Sign Up
315 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fish and Richardson
McKesson
UBS
McKinsey
US Army
Citi
Accenture
Deloitte

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 verifification 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.