On November
08, 2011, Warner Chilcott moved a complaint for patent infringement in the US
District Court for the District of Delaware against the generic manufacturer
Zydus Cadila for alleged infringement of US Pat. No. 6,893,662 (the ‘662
patent) listed with the Orange Book for anti-inflammatory drug Asacol® HD,
generically mesalamine delayed-release tablet. In September 2011, Zydus
submitted an ANDA No. 203-286 to FDA seeking approval to market 800mg
mesalamine delayed-release tablet bioequivalent to Asacol®HD before the
expiration of the ‘662 patent. Zydus, however, made paragraph III certification
for remaining two
The
complaint will automatically trigger 30-month stay of FDA approval. The ‘662
patent claims a compressed 5-ASA (mesalamine) tablet having multiple polymeric
coatings and will expire on November 14, 2021. In its notice to Warner, Zydus
contended that its ANDA is not infringing the ‘662 patent. It seems to be that
Zydus is potentially first to file (FTF) applicant for 800mg mesalamine
delayed-release tablet. Warner is separately litigating the lower dose 400mg
mesalamine delayed-release tablet against Roxane Laboratories, ParPharmaceutical and EMET Pharmaceuticals. Roxane is first the file for 400mg
tablet. In October 2010, Lupin was granted an authorised generic status by
Warner.
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