Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, 1795:TT) today announced that Alvogen US received a decision from the United States District Court for the District of Delaware that Alvogen’s generics alternative to Indivior’s blockbuster Suboxone film is cleared of infringing US Patent No. 8,603,514, and No. 8,900,497. This is one of the products under strategic alliance between Alvogen US and Lotus and with the decision, the two shall proceed with ANDA related preparations. Meanwhile, the Company is prepared if Indivior appeals.
Alvogen US’ ANDA submission took place in 2015 and was sued by Indivior in June of the same year due to the proposed generic’s PIV certification. However, as claimed in the court decision, the proposed generic does not infringe key patents around Suboxone film. Commenting on the decision, Lotus Chairman Andrew Lin said that Buprenorphine/Naloxone tablets, or Desud Plus, have been a major product for Lotus in Taiwan for quite some time, and the Company has been working closely with Alvogen US for many years to extend and upgrade its anti-addiction franchise by developing sublingual film dossiers for the US market. He said that “the alliance spans across R&D, legal and regulatory aspects and two teams will continue to work toward receiving FDA approval with this favorable ruling.” “Buprenorphine/Naloxone film is important for Lotus. We are extraordinarily honored to be potentially one of the pharmaceuticals to provide affordable medical resources to address the worsening opioid use issue in the US. In terms of social impact, we believe this is something local generic manufacturers should celebrate together.”
Lotus said that the demand of opioid use disorder treatment has always been under-met in the US. According to US National Center for Health Statistics, an estimated 116 Americans die every day from drug overdoses, including prescription painkillers, heroin or synthetic products fentanyl, and illegal drug uses. Overdose of prescription has led to 11.5 million Americans’ lives affected, and the combined treatment market size of such and illegal drug uses would be approximately US$24 billion. The Trump administration thus describes this as an “opioid epidemic” and “health emergency” that requires immediate attention.
The Company also pointed out that Dr. Reddy’s received non-infringement decisions from court for the same, aforementioned patents in the third quarter of 2017 as well. As of now, US FDA has not issued any approvals toward generics of Suboxone film and therefore there are currently no generic competitors in the market.