SUPERNUS PHARMACEUTICALS, INC. : Other events, financial statements and exposures (form 8-K)



Article 8.01. Another article.

At June 10, 2021, Newron Pharmaceuticals SpA (“Newron”), Zambon SpA. (“Zambon”) and Supernus Pharmaceuticals, Inc. (the “Company”), through its subsidiary U.S. operations of MDD, LLC (collectively, the “Plaintiffs”), has initiated litigation against the generic drug manufacturers Aurobindo Pharma Limited, Aurobindo Pharma USA Inc., MSN Private Limited Laboratories (“MSN”), Optimus Pharma Pvt Ltd, Prinston Pharmaceutical, Inc., RK Pharma, Inc. and Zenara Pharma Private Limited (collectively, the “Defendants”) for infringement of three patents covering XADAGO®, the Company’s once-daily product indicated as an adjunct to levodopa / carbidopa in patients with Parkinson’s disease who are experiencing episodes “Off”. US Patent Nos. 8,076,515, 8,278,485 and 8,283,380 (collectively, the “XADAGO Patents”) cover pharmaceutical formulation and methods of treatment with safinamide. XADAGO patents expire between June 2027 and March 2031. The Company has a licensing agreement with Zambon, Newron’s partner, related to the XADAGO patents, and as a new chemical entity, XADAGO is under the FDA’s 5-year exclusivity period which expires on March 21, 2022.

The complaint – filed at United States District Court for the District of Delaware – alleges that the Defendants infringed the XADAGO Patents by submitting to the
United States Food and Drug Administration (FDA) Abbreviated New Drug Applications (ANDA) seeking to market a generic version of XADAGO before patents expire. Filing of the complaint within 45 days of receipt of each of the Defendants ‘Paragraph IV notification letters triggers a suspension of FDA approval of the Defendants’ ANDAs.

Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit 104 - The cover page from this Current Report on Form 8-K, formatted in
Inline XBRL.


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