A patent infringement suit was filed by Takeda against Mylan as a result of an Abbreviated New Drug Application (ANDA) no. 202-396 filed by Mylan with the FDA concerning its intent to market lansoprazole delayed release orally disintegrating tablets.
The patents involved in the suit were:
US6328994, entitled Orally disintegrable tablets, issued on Dec 11, 2001 and expiring* by May 18, 2018
US5464632, entitled Rapidly disintegratable multiparticular tablet, issued on Feb 20, 2001 and expiring* by Feb 20, 2018.
The ‘632 patent is currently assigned+ to Ethypharm and ‘994 patent is assigned+ to Takeda (source: MaxVal’s Assignment Database). Takeda is the current holder± of FDA approved New Drug Application (NDA) no. 21-428 for lansoprazole delayed release orally disintegrating tablets, 15 and 30 mg (source: MaxVal’s Patent Marker), which is sold under the name Prevacid® SoluTab™. It is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers) and relieves symptoms such as heartburn, difficulty swallowing, and persistent cough.
The case is now closed as the parties have filed for dismissal. Pursuantly, the Court ordered the dismissal of this case. No further information is available on the terms of settlement at this time.