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MiddleBrook Announces Orange Book Listing of Moxatag Patents.

MiddleBrook Pharmaceuticals, Inc. (Germantown, MD), a pharmaceutical company focused on developing and commercializing novel anti-infective products, said that three patents protecting Moxatag (amoxicillin extended-release) Tablets, 775mg, were listed in the FDA Orange Book on Oct. 24, 2008, pursuant to Section 4 of Public Law No. 110-379, which was enacted on Oct. 8, 2008.

MiddleBrook President & CEO John Thievon said, "Public Law No. 110-379 provides important incentives for drug developers to innovate in the antibiotic arena. MiddleBrook has already made progress in this therapeutic class with Moxatag, the first and only FDA-approved once-daily amoxicillin. We believe that Moxatag addresses significant unmet needs in the antibiotic therapeutic area through patient convenience and a lower overall dose."

Moxatag (extended-release amoxicillin) Tablets, 775mg, is a once-a-day extended-release formulation of amoxicillin for oral administration consisting of three components: one immediate-release component and two delayed-release components. The three components are combined in a specific ratio to prolong the release of amoxicillin from Moxatag compared to immediate-release amoxicillin. Moxatag is intended to provide a lower treatment dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis.

MiddleBrook is a pharmaceutical company focused on developing and commercializing anti-infective products that fulfill unmet medical needs. We are currently developing a portfolio of anti-infective products utilizing our proprietary, once-a-day pulsatile delivery technology called Pulsys. Our near-term corporate strategy is to improve dosing regimens and/or frequency of dosing which we believe will result in improved patient dosing convenience and compliance for antibiotics that have been used and trusted by physicians and patients for decades. MiddleBrook currently markets the Keflex brand of cephalexin and has received regulatory approval for Moxatag -- the first and only once-daily amoxicillin product approved for marketing in the United States.

MiddleBrook Pharmaceuticals, Inc.

+1-301-944-6585

www.middlebrookpharma.com
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Publication:BIOTECH Patent News
Date:Oct 1, 2008
Words:307
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