Innovator Ortho-McNeil have filed suit for patent infringement in the United States District Court of Delaware against Impax for submitting ANDA with Para IV certification for Ultram (Tramadol hydrochloride extended-release tablets,100 mg).
Innovator has sued based on Para IV filing against Orange book listed patent US6254887 (expiry: May 10, 2014) which covers A controlled release preparation for oral administration contains tramadol, or a pharmaceutically acceptable salt thereof, as active ingredient.
Ultram was approved by USFDA on Sep 8, 2005 for 100, 200 and 300 mg/tablet. Innovator is already in litigation with Par pharma (First Para IV filer) for this product
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