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BioDelivery Sciences gets expanded US patent protection on Belbuca, Bunavail & Onsolis

Raleigh, North Carolina
Monday, April 3, 2017, 09:00 Hrs  [IST]

BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, announced that two important new patents were granted extending patent protection around all three of its FDA approved products, Belbuca (buprenorphine) buccal film, Bunavail (buprenorphine and naloxone) buccal film, and Onsolis (fentanyl buccal soluble film), further strengthening BDSI's overall intellectual property position.

In a patent application (US Patent Application Serial No. 15/212,912) covering the composition of the BioErodible MucoAdhesive (BEMA) drug delivery technology, which is the basis for Belbuca and Bunavail, a Notice of Allowance was issued providing additional patent coverage for Belbuca and Bunavail to July 2027. This patent will be listed in the Orange Book.

Additionally, a patent (US Patent No. 9,597,288) was issued on March 21, 2017, which extends patent protection on Onsolis from January 2020 to July 2027. This patent will also be listed in the Orange Book. The US rights to Onsolis are licensed to Collegium Pharmaceutical. Under the terms of BDSI's licensing agreement for Onsolis with Collegium, the patent grant is associated with a $3 million milestone payment to BDSI, the payment of which is due upon US Food and Drug Administration (FDA) approval of a supplemental application supporting the new manufacturer for Onsolis. This, along with a $4 million milestone payment tied to the first commercial sale of Onsolis, are anticipated in the first half of 2018. Under the terms of the agreement with our former US partner, Meda, the milestones and future royalties to BDSI will be shared between BDSI and Meda.

Bunavail (buprenorphine and naloxone) buccal film (CIII) and Belbuca (buprenorphine) buccal film (CIII) are marketed in the US by BioDelivery Sciences. Onsolis (fentanyl buccal soluble film) (CII) is licensed in the US to Collegium Pharmaceutical pursuant to the US licensing and development agreement between BDSI and Collegium.


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