UNITED STATES
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FORM
CURRENT REPORT
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Item 8.01. Other Events.
On September 28, 2023, Harmony Biosciences Holdings, Inc. (the “Company”) received paragraph IV certification notices (the “Notices”) from Novugen Pharma Sdn. Bhd. and Lupin Ltd. (together, the “ANDA Filers”) advising that the ANDA Filers had each filed with the U.S. Food and Drug Administration (“FDA”) an Abbreviated New Drug Application (“ANDA” and, together, the “ANDAs”), seeking approval to manufacture and sell a generic version of the Company’s product WAKIX® (pitolisant) in the United States prior to the expiration of U.S. Patents Nos. 8,486,947 and 8,207,197 (the “Challenged Patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange Book” and which expire September 26, 2029 and March 7, 2030 respectively. The Notices do not challenge U.S. Patent No. 8,354,430 which expires February 6, 2026. The Notices allege that the Challenged Patents are invalid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of the generic product in the ANDAs. The Company is currently reviewing the Notices and intends to vigorously defend and enforce its intellectual property rights protecting WAKIX. As of the date of this filing, the Company is not aware of any other ANDA filers.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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No. | Description | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
HARMONY BIOSCIENCES HOLDINGS, INC. | ||
Date: October 4, 2023 | By: | /s/ Christian Ulrich |
Christian Ulrich | ||
SVP & General Counsel | ||