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Generated: March 21, 2019

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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
Bulk Api Vendors: 1
Formulation / Manufacturing:see details
DailyMed Link:TEKAMLO at DailyMed
Drug patent expirations by year for TEKAMLO
Generic Entry Opportunity Date for TEKAMLO
Generic Entry Date for TEKAMLO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for TEKAMLO
Aliskiren / amlodipine
Aliskiren mixture with amlodipine
S900005660

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 ➤ 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
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-002 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
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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Expired US Patents for TEKAMLO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 ➤ Sign Up ➤ Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-003 Aug 26, 2010 ➤ Sign Up ➤ Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 2010 ➤ Sign Up ➤ Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-002 Aug 26, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for TEKAMLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0678503 CA 2011 00027 Denmark ➤ Sign Up
0678503 C300296 Netherlands ➤ Sign Up PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
1602370 2009/010 Ireland ➤ Sign Up 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
0678503 C300499 Netherlands ➤ Sign Up PRODUCT 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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