Valeant: Is Teva’s Generic Uceris Finally Here?

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In Q4 2017 a Delaware court ruled in favor of Teva (TEVA) in its challenge of patents covering Valeant’s (VRX) Uceris (budesonide ER) tablets:

Teva Pharmaceutical Industries Ltd. (OTCPK:TEVJF), (NYSE and TASE: TEVA) today announced that the United States 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’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.

“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.” said Dipankar Bhattacharjee, President and CEO, Global Generic Medicines, Teva. “This presents another first generic opportunity for Teva and we look forward to offering this product to our customers when otherwise able to.”

Teva believed it would eventually become the first applicant to file an ANDA for generic Uceris and thus, could be rewarded a 180-day period of generic market exclusivity. I assumed Teva would launch generic Uceris within months. The problem was that Teva not only need a favorable court ruling, but it also needed FDA approval. It appears the FDA finally approved generic Uceris last week.

The news barely made headlines, nor did it impact Valeant’s share price. However, Shocking The Street, a premium investment service the Shock Exchange runs in conjunction with Seeking Alpha believes generic Uceris could sting VRX. Read more:

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