BioDelivery Sciences in patent deal with Teva

BioDelivery Sciences International (BDSI) said it entered into a settlement agreement with Teva Pharmaceuticals USA, Actavis Laboratories UT, and Teva Pharmaceuticals Industries that resolves BDSI’s previously reported Bunavail patent litigation against Teva pending in the US District Court for the District of Delaware.

“We are pleased to have resolved this lawsuit with Teva regarding Bunavail, as it provides additional certainty to our patent portfolio, and allows us to move forward while averting future costs associated with this litigation,” said BioDelivery Sciences CEO Mark Sirgo.

BDSI alleged in the lawsuits that the generic form of Bunavail (buprenorphine and naloxone) buccal film, which Teva is seeking approval to market in the United States pursuant to two Abbreviated New Drug Application (ANDA) filings with the US Food and Drug Administration (FDA), infringed upon several US patents owned by BDSI.

BDSI said: “As part of the settlement agreement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, BDSI has entered into a non-exclusive license agreement with Teva that permits Teva to first begin selling its generic version of Bunavail in the U.S. on July 23, 2028 or earlier under certain circumstances.”