Recent U.S. patents on protein drug formulation: 2000-2007.

This review summarizes U.S. patents on protein drug formulation issued during the period 2000-2007. The patents fall into four major areas: (i) protein stabilization in solution and solid formulations, (ii) polymer-conjugated and chemically modified proteins, (iii) controlled release protein formulations, and (iv) protein formulation for novel routes of administration. Patents issued in each of the four areas are described and possible areas for additional research are noted.