US-based Purdue Pharma Products LP and UK-based Napp Pharmaceutical Group have sued Lupin Ltd and its US subsidiary, Lupin Pharma Inc, claiming that their attempt to manufacture and market the generic version of the analgesic tramadol ER (brandname-Ultram ER) infringes patent coverage of the innovator.
Purdue has alleged that Lupin, by filing an abbreviated new drug application with the US Food and Drug Administration and by seeking an approval to manufacture and market tramadol hydrochloride controlled-release tablets of strength-100 mg, 200 mg and 300 mg, has violated patent numbers 887 and 430.
?The acts of infringement by Lupin set forth above will cause plaintiffs irreparable harm for which they have no adequate remedy at law, and will continue unless enjoined by this court,? Prudue and Napp submitted in a plea to the US District Court at Delaware.
An executive of Lupin declined to comment.