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  1. Adare Pharmaceuticals
24 April 2012

Aptalis Wins Appeal Against Generic Version of AMRIX

Aptalis (previously known as Eurand, Inc.), Cephalon, a wholly-owned subsidiary of Teva Pharmaceuticals Industries Ltd, and Anesta AG prevailed in their appeal to the U.S. Court of Appeals for the Federal Circuit, which reversed a lower court’s determination and held that two patents covering the AMRIX muscle relaxant (Cyclobenzaprine Hydrochloride Extended-Release Capsules) are valid.

The two patents, owned by Aptalis Pharmatech and licensed to Cephalon, expire in 2023 and 2025. The patents, along with other additional patents that protect AMRIX, are all listed on the FDA’s ‘Orange Book’ and will be enforced to the fullest extent possible.

AMRIX is a convenient, extended-release (once-daily administration) dosage form of cyclobenzaprine that is intended for short-term relief of muscle spasm as an adjunct to rest and physical therapy. Prior to the approval of AMRIX in 2007, only immediate-release formulations of cyclobenzaprine were available, such formulations often requiring administration two to three times daily. According to recent IMS data, cyclobenzaprine is the most frequently prescribed drug for muscle relaxation in the United States.

The use of Aptalis Pharmaceutical Technologies DlFFUCAPS Technology in AMRIX satisfies an unmet medical need by providing a modified-release formulation, once-daily dosing of cyclobenzaprine, thereby allowing for increased patient compliance.

"Aptalis Pharmaceutical Technologies endeavours to offer to our partners the most effective patent protection possible of our broad and diversified portfolio and this court decision confirms the strength of these formulation patents," said John Fraher, president of Aptalis Pharma.

The Aptalis portfolio is composed of numerous patents with broad claims directed to its formulation technologies and related materials, processes, equipment and methods of manufacture. Aptalis has many product-related patents, which contain more specific claims directed to particular drugs or classes of drugs in combination with our formulation technologies. Aptalis’ owned and in-licensed patent portfolio consists of over 900 granted patents and pending applications.

Dysphagia can affect many people throughout their lifetime and may compromise medication adherence.
For pharmaceutical manufacturers and healthcare providers, non-adherence to medication is a significant concern.
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