Sweden-based Orexo files a lawsuit against Sun Pharma in US District Court

According to Orexo's statement, the lawsuit was filed in response to an ANDA filed by Sun with the USFDA

Sep 15, 2020 12:09 IST India Infoline News Service

Sun Pharma
Sun Pharma stock was in focus on Tuesday's trading session after the Sweden-based Orexo AB announced that it filed a patent infringement action in the United States District Court for the District of New Jersey, against the pharma-major. Orexo filed a lawsuit against Sun Pharma along with Sun Pharma Global FZE, Sun Pharma Global and Sun Pharmaceutical Industries, Inc. (collectively “Sun”).

On Sensex, Sun Pharma stock has surged by more than 3% with an intraday high of Rs512.65 per piece. However, at around 12.25 pm, the stock has corrected and was trading at Rs506.40 per piece surging by 2.14% on Sensex.

The stock remains among top performers on exchanges.

According to Orexo's statement on Monday, the lawsuit was filed in response to an Abbreviated New Drug Application (ANDA) filed by Sun with the US Food and Drug Administration (FDA).

Under the ANDA filing, Sun seeks to market and sell generic versions of Orexo’s ZUBSOLV products, (buprenorphine and naloxone) sublingual tablets (CIII), in the US before the expiration of the patents listed in FDA’s Orange Book.

Nikolaj Sørensen, Orexo’s president and CEO on September 14, said: ”Today Orexo is much more well prepared to defend the exclusivity of ZUBSOLV than when we started our previous patent litigation. We successfully defended the exclusivity for ZUBSOLV in the past and we are well prepared to do so again by enforcing our patent rights against Sun.”

Expiration dates for the patents range from December 2027 to September 2032.

The Sweden-based company said, since Orexo timely filed a lawsuit against Sun, FDA is statutorily precluded from approving Sun’s ANDA for 30 months, or until a district court decision finds the patents to be invalid or not infringed, whichever occurs first. The 30-month stay period began as of the date Orexo received the notice letter from Sun advising Orexo of their ANDA filing.

Following the above, Orexo expects increased legal expenses related to the litigation process, with the majority of the expenses expected in 2021 and 2022. The expenses in 2020 are expected to be non-material and any changes to OPEX guidance will be shared in quarterly reports. 

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