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MonoSol Rx Announces Listing of Patent in FDA Orange Book for Suboxone® Sublingual Films

Warren, NJ (November 30, 2011) – MonoSol Rx, LLC (“MonoSol Rx”), the developer of PharmFilm® drug delivery technology and a drug delivery company specializing in film pharmaceutical products, announced that the U.S. Food and Drug Administration (FDA) has listed MonoSol Rx’s U.S. Patent No. 8,017,150 in the Orange Book for the Suboxone® (buprenorphine HCl and naloxone HCl dihydrate) sublingual film products.

The Suboxone® sublingual film products were developed utilizing MonoSol Rx’s PharmFilm® technology under a collaboration with Reckitt Benckiser Pharmaceuticals Inc.  Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc (LSE: RB), currently markets Suboxone® sublingual film for the maintenance treatment of opioid dependence.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals – Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the maintenance treatment of opioid dependence.

MonoSol Rx’s commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).For existing and future partners, PharmFilm® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration.  For press releases and other company information visit www.monosolrx.com.

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