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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Teva
Baxter
UBS
Covington
Harvard Business School
Mallinckrodt
Healthtrust
Julphar

Generated: May 24, 2018

DrugPatentWatch Database Preview

TEKAMLO Drug Profile

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Which patents cover Tekamlo, and when can generic versions of Tekamlo launch?

Tekamlo is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.

This drug has eighty-eight patent family members in thirty-four countries.

The generic ingredient in TEKAMLO is aliskiren hemifumarate; amlodipine besylate. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate profile page.
Summary for TEKAMLO
International Patents:88
US Patents:2
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
DailyMed Link:TEKAMLO at DailyMed
Drug patent expirations by year for TEKAMLO

US Patents and Regulatory Information for TEKAMLO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 2010 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-002 Aug 26, 2010 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 2010 DISCN No No ➤ Sign Up ➤ Sign Up 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 TEKAMLO

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

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Supplementary Protection Certificates for TEKAMLO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0678503/02 Switzerland ➤ Sign Up PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
2011 00027 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
00625 Netherlands ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
QuintilesIMS
Queensland Health
Moodys
US Army
Merck
Citi
Accenture
Cantor Fitzgerald

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.