Teva Pharmaceutical Industries said the US District Court for the District of Delaware ruled in the company’s favor in patent litigation involving Teva’s abbreviated new drug application (ANDA) directed to a generic version of Valeant’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,” said Teva.
Dipankar Bhattacharjee, president and CEO, Global Generic Medicines, Teva, said: “We are pleased to have another legal win on one of our first-to-file PIV patent challenges brought in through the Actavis Generics acquisition.
“This presents another first generic opportunity for Teva and we look forward to offering this product to our customers when otherwise able to.”
Teva said based on available information, it 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,” said Teva.
“Uceris had annual sales of approximately $191 million in the U.S., according to IMS data as of September 2017.”