UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01. Other Events.
On June 5, 2025, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing a settlement agreement with Lupin Limited (“Lupin”), resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will be dismissed, and Lupin will receive a license to launch its generic product no earlier than January 2030 (or July 2030 with pediatric exclusivity), or earlier under certain circumstances.
The full text of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
| |
No. | Description | |
99.1* | ||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* | This Exhibit is furnished herewith and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference. |
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: June 5, 2025 | By: | /s/ Christian Ulrich |
Christian Ulrich | ||
SVP and General Counsel | ||