Janssen Pharmaceutica Products, L.P. (a subsidiary of Johnson & Johnson) and Synaptech filed suit against Barr Laboratories Inc., for patent infringement relating to Razadyne (galantamine hydrobromide), 4 mg, 8 mg, and 12 mg Tablets, formerly Reminyl. The action was initiated under the Hatch-Waxman Act as an infringement of a patent on the compound that expires in December 2008. They also filed against Teva Pharmaceutical Industries Ltd. Mylan Laboratories Inc., Dr. Reddy’s Laboratories Ltd. and Alpharma Inc.
Barr filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Razadyne tablets on February 28, 2005, the first day that an ANDA containing a Paragraph IV certification could be submitted based on the expiration of the New Chemical Entity (NCE) exclusivity on the product.
Barr received notification from the FDA of the application’s acceptance for filing in April 2005. Following receipt of notice from FDA, Barr notified Janssen, the New Drug Application (NDA) holder, and Synaptech, the patent owner, of Barr’s challenge to the patents protecting Razadyne.
Razadyne, formerly Reminyl, is a tertiary alkaloid that has been extracted from plant sources and is now synthesized for use in the treatment of mild to moderate Alzheimer’s disease (AD). Galantamine acts both as a reversible competitive inhibitor of acetylcholinesterase (AChE) and as an allosteric modulator of nicotinic acetylcholine receptors.
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