Otsuka Files Challenge to ANDA for Low Blood Sodium Treatment


On Thursday a case was filed in the Delaware District Court by Otsuka Pharmaceuticals against MSN Laboratories Private Limited and MSN Pharmaceuticals Inc. Otsuka’s complaint alleges patent infringement in connection with Samsca tovaptan tablets.

Samsca, per the complaint, is an oral medication used to treat hyponatremia (low blood sodium) in adults with conditions including congestive heart failure, cirrhosis, and inappropriate antidiuretic hormone syndrome. 

The plaintiff accuses the defendant of submitting an abbreviated new drug application (ANDA) prior to the expiration of the patent in order to supply a generic version of the drug. The defendant has not licensed the drug from the plaintiff patent holder, and has not submitted any request to do so prior to the filing of the suit, according to Otsuka.

Plaintiff is suing for patent infringement, declaratory judgment and an injunction prohibiting further creation or sale of the infringing generic prior to the expiration of the patents for Samsca. Plaintiff is represented by Morris Nichols Arsht & Tunnell LLP.