Teva Pharmaceutical Industries today announced that the US District Court for the District of Delaware has ruled in the company's favor in patent litigation involving Teva's Abbreviated New Drug Application (ANDA) directed to a generic version of Valeant Pharmaceutical International's Uceris (budesonide ER) tablets.
At trial in May, the Court found that plaintiffs did not meet the threshold to establish infringement, and the Court has now issued its written decision confirming that Teva's ANDA product does not infringe the asserted patent.
Based on available information, Teva believes it is a "first applicant" to file an ANDA for the generic version of Uceris. Should its ANDA be approved, Teva may be entitled to 180 days of generic market exclusivity.
Uceris had annual sales of approximately $191 million in the USA, according to IMS data as of September 2017.
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