Extended release formulations of erythromycin derivatives

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills

Reexamination Certificate

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C424S468000, C424S480000

Reexamination Certificate

active

06872407

ABSTRACT:
Disclosed is a pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment. The composition comprises an erythromycin derivative and a pharmaceutically acceptable polymer so that, when ingested orally, the composition induces statistically significantly lower Cmaxin the plasma than an immediate release composition of the erythromycin derivative while maintaining bioavailability and minimum concentration substantially equivalent to that of the immediate release composition of the erythromycin derivative upon multiple dosing. The compositions of the invention have an improved taste profile and reduced gastrointestinal side effects as compared to those for the immediate release composition.

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Opponent Sanovel's Opposition to EP-B1-0 973 527.
Opponenet Niche Generics Limited's Opposition to EP-B1-0 973 527.

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