Innovator Daiichi has sued generic player Apotex for filing ANDA with Paragraph IV certification to market Cevimeline Hydrochloride (Evoxac) 30 mg Capsules. Innovator has sued Apotex in US district court for the district of Delaware. Following patents are listed in the Orange Book for this product:
US4855290 (Expiry: Aug 30, 2009): which covers various quinuclidine derivatives as product
US5340821 (Expiry: Jul 7, 2013): The patent covers a method for treating the symptoms of Sjoegren syndrome
As per complaint, innovator has alleged infringement of ‘821 patent by Apotex.
Innovator got approval to market Cevimeline (2-methyspiro (1,3- oxathiolane- 5,3) quinuclidine) Hydrochloride hydrate (Evoxac) 30 mg Capsules on Jan 11, 2000.
Cevimeline is a parasympathomimetic and muscarinic agonist and clinically used for the treatment of dry mouth associated with sjoegren syndrome
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