US Patent

US8613949 — Galenical formulations of organic compounds

Formulation · Assigned to Novartis AG · Expires 2029-12-21 · 4y remaining

Vulnerability score 53/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects a specific oral fixed-dose combination of Aliskiren and Amlodipine with controlled dissolution profiles.

USPTO 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.

Drugs covered by this patent

Patent Metadata

Patent number
US8613949
Jurisdiction
US
Classification
Formulation
Expires
2029-12-21
Drug substance claim
No
Drug product claim
Yes
Assignee
Novartis AG
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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