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Details for Patent: 8,613,949

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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;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-001Aug 26, 2010DISCNNo8,613,949► subscribeY
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-002Aug 26, 2010DISCNNo8,613,949► subscribeY
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-003Aug 26, 2010DISCNNo8,613,949► subscribeY
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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

International Patent Family for Patent: 8,613,949

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan2015091830► subscribe
South Korea20110060942► subscribe
Morocco32719► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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