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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Chubb
Fuji
Federal Trade Commission
Boehringer Ingelheim
Dow
Express Scripts
Harvard Business School

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,613,949

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Which drugs does patent 8,613,949 protect, and when does it expire?

Patent 8,613,949 protects TEKAMLO and is included in one NDA.

This patent has twenty-two patent family members in twenty countries.
Summary for Patent: 8,613,949
Title:Galenical formulations of organic compounds
Abstract: The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Amlodipine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component (a) of 60% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component (b) of 50% or more after 20 minutes, and 70% or more after 30 minutes at pH 2, said pharmaceutical oral fixed dose combination being bioequivalent, or close to reaching bioequivalence, to a free dose combination of Aliskiren and Amlodipine.
Inventor(s): Valazza; Stephen (Matawan, NJ), Wagner; Robert F (Hillsborough, NJ), Vippagunta; Sudha (Morris Plains, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:13/063,955
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use;

Drugs Protected by US Patent 8,613,949

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
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 022545-002 Aug 26, 2010 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-003 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. Patented / Exclusive Use Patent Submitted

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Foreign Priority and PCT Information for Patent: 8,613,949

PCT Information
PCT FiledSeptember 22, 2009PCT Application Number:PCT/US2009/057750
PCT Publication Date:March 25, 2010PCT Publication Number: WO2010/033954

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Julphar
Citi
Harvard Business School
Express Scripts
Covington
Daiichi Sankyo
Cerilliant
Cantor Fitzgerald

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