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Serving leading biopharmaceutical companies globally:

Julphar
Chinese Patent Office
Teva
Federal Trade Commission
Citi
McKesson
Novartis
Dow
Deloitte
Daiichi Sankyo

Generated: November 19, 2017

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-two patent family members in thirty-five countries and forty-two supplementary protection certificates in twelve countries.

There are four drug master file entries for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide.

Summary 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;ORAL200045-004Dec 21, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-002Dec 21, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-001Dec 21, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-002Dec 21, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-004Dec 21, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-003Dec 21, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-003Dec 21, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-003Dec 21, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-005Dec 21, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-001Dec 21, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,168,616Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension► Subscribe
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► Subscribe
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids► Subscribe
5,705,658 Azido containing tetrahydro furan compounds► Subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
9,023,893Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
5,659,065 Alpha-aminoalkanoic acids and reduction products► Subscribe
9,023,894Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0240007► Subscribe
Luxembourg91373► Subscribe
South Korea20100137026► Subscribe
Spain2369216► Subscribe
Germany122011100052► Subscribe
Poland372203► Subscribe
Czech Republic305341► Subscribe
Poland400915► Subscribe
Norway20045459► Subscribe
Japan2009235107► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB07/060United Kingdom► SubscribePRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822
90055-0Sweden► SubscribePRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414
C0020France► SubscribePRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
11/2009Austria► SubscribePRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON
/2009Austria► SubscribePRODUCT 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
0678503/01Switzerland► SubscribePRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
00499Netherlands► SubscribePRODUCT 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
564Luxembourg► Subscribe91564, EXPIRES: 20200407
0678503/04Switzerland► SubscribePRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
90018-9Sweden► SubscribePRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
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Serving leading biopharmaceutical companies globally:

Merck
QuintilesIMS
Deloitte
Dow
Cantor Fitzgerald
Chubb
McKinsey
US Department of Justice
Covington
Harvard Business School

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.

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