Benzinga | May 19, 2021 04:16PM EDT

Supernus Pharmaceuticals Says Co. And Newron Received Notice Letters From MSN Laboratories, Optimus Pharma And Zenara Pharma Advising Supernus Of Filings Of Abbreviated NDAs To FDA Seeking Approval Of Mesylate Tablets

On each of May 14, 2021, May 15, 2021 and May 17, 2021, Supernus Pharmaceuticals, Inc. (the "Company") and Newron Pharmaceuticals S.p.A. ("Newron") received Paragraph IV Notice Letters ("Notice Letters") from MSN Laboratories Private Limited ("MSN"), Optimus Pharma Pvt Ltd ("Optimus") and Zenara Pharma Private Limited ("Zenara"), respectively, advising the Company and Newron of the filing by MSN, Optimus and Zenara of Abbreviated New Drug Applications to the U.S. Food and Drug Administration ("FDA") seeking approval for safinamide mesylate tablets. The Notice Letters are directed to the three XADAGO patents with U.S. patent numbers 8,076,515, 8,278,485 and 8,283,380, that expire between June 2027 and December 2028 and are listed in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The Company has a license agreement with Zambon S.p.A., Newron's partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO is under the 5 year FDA exclusivity period that expires on March 21, 2022. The Company is currently reviewing the details of the Notice Letters with its partners to respond as appropriate to protect the intellectual property rights relating to XADAGO.

The information furnished in this Item 7.01 of this Current Report on Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.