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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Cantor Fitzgerald
Merck
Chinese Patent Office
Novartis
Boehringer Ingelheim
US Army
Fuji
AstraZeneca
Accenture

Generated: January 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 freedom to operate?

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.

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

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 200045-005 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-002 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-001 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-002 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-005 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-002 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-003 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-004 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-004 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-004 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Subscribe
8,168,616 Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension ➤ Subscribe
5,659,065 Alpha-aminoalkanoic acids and reduction products ➤ Subscribe
9,023,893 Synergistic combinations comprising a renin inhibitor for cardiovascular diseases ➤ Subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Subscribe
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones ➤ Subscribe
9,023,894 Synergistic combinations comprising a renin inhibitor for cardiovascular diseases ➤ Subscribe
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids ➤ Subscribe
5,705,658 Azido containing tetrahydro furan compounds ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0055 France ➤ Subscribe PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
90018-9 Sweden ➤ Subscribe PRODUCT 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
00386 Netherlands ➤ Subscribe PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028
11/2009 Austria ➤ Subscribe PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON
13/058 Ireland ➤ Subscribe 2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
C0020 France ➤ Subscribe PRODUCT 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
2009 00010 Denmark ➤ Subscribe PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028
09/010 Ireland ➤ Subscribe PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028
12/018 Ireland ➤ Subscribe PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
000 Luxembourg ➤ Subscribe 92000, EXPIRES: 20260705
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Deloitte
Novartis
Cerilliant
McKinsey
Johnson and Johnson
Chinese Patent Office
Dow
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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