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Serving leading biopharmaceutical companies globally:

Accenture
McKinsey
Moodys
Citi
Chubb
UBS
Express Scripts
US Army
US Department of Justice
Medtronic

Generated: January 17, 2018

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Aliskiren hemifumarate; amlodipine besylate - Generic Drug Details

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

Aliskiren hemifumarate; amlodipine besylate
is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; amlodipine besylate has eighty-eight patent family members in thirty-four countries.

There are four drug master file entries for aliskiren hemifumarate; amlodipine besylate.
Summary for aliskiren hemifumarate; amlodipine besylate
International Patents:88
US Patents:4
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 4
Clinical Trials: 547
Drug Prices:see low prices
DailyMed Link:aliskiren hemifumarate; amlodipine besylate at DailyMed

US Patents and Regulatory Information for aliskiren hemifumarate; amlodipine besylate

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-005 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 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 200045-002 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 TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 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 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 200045-004 Dec 21, 2010 DISCN No No ➤ Subscribe ➤ Subscribe Y 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

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
5,659,065 Alpha-aminoalkanoic acids and reduction products ➤ Subscribe
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones ➤ Subscribe
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Subscribe
5,705,658 Azido containing tetrahydro furan compounds ➤ Subscribe
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids ➤ Subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for aliskiren hemifumarate; amlodipine besylate

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C041/2007 Ireland ➤ Subscribe SPC041/2007: 20080416, EXPIRES: 20200406
2011 00027 Denmark ➤ Subscribe
/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; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028
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
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
0296 Netherlands ➤ Subscribe 300296, 20150407, EXPIRES: 20200406
373 Luxembourg ➤ Subscribe 91373, EXPIRES: 20200407
2013000093 Germany ➤ Subscribe PRODUCT NAME: KOMBINATION UMFASSEND ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/686/001 - 056 20110414
0625 Netherlands ➤ Subscribe 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
2013 00062 Denmark ➤ Subscribe PRODUCT NAME: KOMBINATION OMFATTENDE ALISKIREN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HEMIFUMARAT, OG AMLODIPIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BENSYLAT; REG. NO/DATE: EU/1/11/686/001/056 20110418
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cipla
Boehringer Ingelheim
McKesson
Chubb
Teva
Cerilliant
Novartis
UBS

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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