Company: SUPN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0001356576-25-000017
Chunk: 477

Company: SUPERNUS PHARMACEUTICALS, INC.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1A
Chunk 477
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us Pharmaceuticals, Inc. v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc., C.A. No. 24-cv-9380 (KMW) (MJS) (D.N.J)

The Company received a Paragraph IV Notice Letter from generic drug maker Aurobindo Pharma Ltd. dated August 9, 2024, directed to eleven of its Oxtellar XR® Orange Book patents. Supernus’s U.S. Patent Nos. 7,722,898; 7,910,131; 8,617,600; 8,821,930; 9,119,791; 9,351,975; 9,370,525; 9,855,278; 10,220,042; 11,166,960; and 11,896,599 generally cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. The FDA Orange Book lists all eleven of the Company’s Oxtellar XR® patents as expiring on April 13, 2027. On September 23, 2024, the Company filed a lawsuit against Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc. (collectively, “Aurobindo”) alleging infringement of the Company’s eleven Oxtellar XR® patents. The Complaint—filed in the U.S. District Court for the District of New Jersey—alleges, among other things, that Aurobindo infringed the Company’s Oxtellar XR® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR® prior to the expiration of the Company’s patents. Filing its September 23, 2024, Complaint within 45 days of receiving Aurobindo’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Aurobindo’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter. The Company entered into a settlement agreement with Aurobindo, and on December 9, 2024, a stipulation of dismissal without prejudice was entered by the U.S. District Court for the District of New Jersey. The agreement has been submitted to the applicable governmental agencies.

Trokendi XR®

III. Supernus Pharmaceuticals, Inc. v. Ajanta Pharma Limited, et al., C.A