Orange Book Listing Opportunities for Drug-Device Combinations


By: Terry G. Mahn, Michael A. Siem, and Elizabeth M. Flanagan

BNA Pharmaceutical Law & Industry Report, 9 PLIR 1500, 12/02/2011.

With many blockbuster drugs coming off patent in the next several years, Branded Pharmaceutical Companies are looking for more and more ways to protect their products. Increasingly, such companies are listing patents covering medical devices integral to drug delivery in the Orange Book as a means to do so.  As described below this practice appears to be proper and presents an intriguing strategy to protect market share.

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