Item 7.01 Regulation FD Disclosure.

On December 20, 2021, BioDelivery Sciences International, Inc. (the "Company") issued a press release to announce that the United States District Court for the District of Delaware (the "Court") issued an opinion in favor of the Company in the Company's previously disclosed patent litigation against Alvogen PB Research & Development LLC, Alvogen Malta Operations Ltd., Alvogen Pine Brook LLC, Alvogen, Inc. and Alvogen Group, Inc. (together, "Alvogen"). A copy of the press release is furnished as Exhibit 99.1 to this report on Form 8-K.

The information set forth under this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.




Item 8.02   Other Events.

On December 20, 2021, the Court issued an opinion in favor of the Company in the Company's previously disclosed patent litigation against Alvogen. The Court's opinion upheld the validity of claims in the Company's patent 8,147, 866 (the "'866 Patent"), which expires in 2027, and patent 9,901,539, which expires in 2032. Alvogen conceded infringement of these claims. Accordingly, BDSI expects to maintain market exclusivity of BELBUCA against Alvogen until 2032. The Company had previously settled a lawsuit over the '866 Patent with Teva Pharmaceuticals USA ("Teva") that granted Teva the right to begin selling its generic product on January 23, 2027, or earlier under certain circumstances. The Court's opinion also stated that some claims of the '866 Patent and patent 9,655,843, a third Company patent which expires in 2027, are invalid. Item 9.01 Financial Statements and Exhibits.





(d) Exhibits
   Exhibit
     No.            Description
    99.1              Press release issued by the Company on December 20, 2021, furnished herewith

     104            Cover Page Interactive Data File (embedded within the Inline XBRL document
                    contained in Exhibit 104)

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