SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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|Item 8.01|| |
On March 1, 2023, Catalyst Pharmaceuticals, Inc. (the “Company”) and its licensing partner SERB SA (“SERB”), initiated litigation against each of (i) Annora Pharma Private Limited, Grave Consulting Services, Inc., Hetero Labs Limited, and Hetero USA, Inc. (collectively, “Hetero”), (ii) Lupin Ltd., Lupin, Inc. and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”), and (iii) Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Limited (collectively, “Teva”, and together with Hetero and Lupin, the “Defendants”) for infringement of six patents covering FIRDAPSE® (amifampridine) tablets 10mg for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) for adults and children aged six and up. The litigation involves United States patent nos. 10,626,088, 10,793,893, 11,060,128, 11,268,128, 11,274,331 and 11,274,332 (collectively, the “Patents”) related to FIRDAPSE®. The Patents will begin to expire in April 2034. The Company licenses the Patents from SERB. As an orphan drug, FIRDAPSE® is under a seven year exclusivity period with the United States Food and Drug Administration (“FDA”) that expires in November 2025.
The lawsuits, each of which were filed in the United States District Court for the District of New Jersey, allege that the Defendants infringed the Patents by submitting to the FDA Abbreviated New Drug Applications (ANDAs) seeking to market a generic version of FIRDAPSE® prior to the expiration of the Patents. Filing the lawsuits within 45 days of receiving each of the Defendants’ Paragraph IV notice letters triggers an automatic stay precluding the FDA from approving any ANDA for FIRDAPSE® until the earlier of May 2026 or entry of a judgment holding the patents invalid, unenforceable, or not infringed, whichever first occurs.
Although there can be no assurance, the Company believes that its patent estate will protect FIRDAPSE® from generic competition for the life of its patents.
The Company plans to provide updates on any additional Paragraph IV certification notices that it may receive from ANDA filers seeking approval of a generic version of FIRDAPSE® in its Quarterly Reports on Form 10-Q and its Annual Reports on Form 10-K filed with the Securities and Exchange Commission.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Catalyst Pharmaceuticals, Inc.|
/s/ Alicia Grande
|Vice President, Treasurer and CFO|
Dated: March 7, 2023