BioDelivery Sciences International, Inc. (BDSI) said it entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries, Ltd. that resolves BDSI’s Belbuca (buprenorphine) buccal film (CIII) patent litigation against Teva pending in the US District Court for the District of Delaware.
BDSI is a specialty pharmaceutical company with a focus in pain management and addiction medicine.
“We are pleased to have resolved our Belbuca lawsuit with Teva,” said Scott Plesha, president of BioDelivery Sciences.
“We believe that this settlement, together with our previously announced settlement of the lawsuit with Teva regarding Bunavail, provide additional certainty around our patent portfolio and the future potential for our two commercialized products.
“Importantly, settling these lawsuits allows us to avoid future litigation costs and thus preserve capital resources.”
BDSI had alleged in the lawsuits that the generic form of Belbuca which Teva is seeking approval to market in the United States infringed on two US patents owned by BDSI.
“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 Belbuca in the U.S. on January 23, 2027 or earlier under certain circumstances,” said BDSI.
Other terms of the agreement are confidential.