Barr Confirms Patent Challenge of Razadyne(R) Tablets
Barr Pharmaceuticals, Inc. confirmed that Janssen Pharmaceutica Products, L.P. and Synaptech filed suit against the Company's subsidiary, Barr Laboratories, Inc., in the District Court of Delaware, relating to the patents protecting Razadyne(R) (Galantamine Hydrobromide), 4 mg, 8 mg and 12 mg Tablets, formerly Reminyl(R). This suit officially initiates the patent challenge process under the Hatch-Waxman Act.
Barr filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Janssen's Razadyne (Galantamine Hydrobromide), 4 mg, 8 mg and 12 mg 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.
In its Form 10-Q filed with the Securities and Exchange Commission on May 10, 2005, Janssen, a subsidiary of Johnson & Johnson, announced that it had received Paragraph IV certifications for Razadyne from six other generic pharmaceutical companies relating to the patents protecting Razadyne 4 mg, 8 mg and 12 mg Tablets from generic competition. Janssen indicated they are in the process of evaluating these certifications.
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