Company: SUPN
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001356576-25-000071
Chunk: 270

Company: SUPERNUS PHARMACEUTICALS, INC.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 8
Chunk 270
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9,662,338 as expiring on April 02, 2035; and United States Patent Nos. 11,324,753; 11,458,143; and 12,121,523 as expiring on September 04, 2029. On September 15, 2025, the Company filed a lawsuit against Zenara and Macleods Pharma USA, Inc. (“Macleods USA” and collectively with Macleods Ltd., “Defendants”) alleging infringement of the Company’s Qelbree® Orange Book patents. The Complaint—filed in the U.S. District Court for the District of Delaware—alleges, inter alia, that Defendants infringed the Company’s Qelbree® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Qelbree® prior to the expiration of the 

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Company’s patents. Filing its September 15, 2025, Complaint within 45 days of receiving Defendants’ Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Defendants’ ANDA until October 02, 2028. On October 22, 2025, Supernus filed a notice of voluntary dismissal of the Complaint without prejudice. The dismissal will not impact the co-pending matter against Defendants, C.A. No. 25-cv-15399 (MEF)(MAH) (D.N.J.), discussed in Section XII above.

Trokendi XR®

XIV. Supernus Pharmaceuticals, Inc. v. Ajanta Pharma Limited, et al., C.A. No. 21-cv-6964 (GC)(DEA) (D.N.J.)

The Company received a Paragraph IV Notice Letter from generic drug maker Ajanta Pharma Limited dated February 10, 2021, directed to ten of its Trokendi XR® Orange Book patents. Supernus's U.S. Patent Nos. 8,298,576; 8,298,580; 8,663,683; 8,877,248; 8,889,191; 8,992,989; 9,549,940; 9,555,004; 9,622,983; and 10,314,790 generally cover once-a-day topiramate formulations and methods of treating or preventing seizures and migraines using those formulations. The FDA Orange Book currently lists United States Patent No.