UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): May 8, 2024
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Item 8.01. Other Events.
As previously disclosed, in March and April 2024, Esperion Therapeutics, Inc. (“Esperion”) received notice letters from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL® (bempedoic acid) Tablet and three of which filed with respect to NEXLETOL and NEXLIZET® (bempedoic acid and ezetimibe) Tablet (each, an “ANDA Filer”), notifying Esperion that each company had filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval of a generic version of NEXLETOL and/or NEXLIZET in the United States, as applicable.
On May 8, 2024, Esperion filed a patent infringement lawsuit under the Hatch-Waxman Act in the United States District Court, District of New Jersey, against Micro Labs USA Inc. (along with an affiliate), an ANDA Filer with respect to NEXLETOL. Esperion’s complaint alleges that by filing the applicable ANDA, such ANDA Filer has infringed NEXLETOL’s Orange Book patents included in its Paragraph IV certifications, and seek an injunction preventing FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent the ANDA Filer from commercializing a generic version of NEXLETOL until the expiration of the asserted patents. Esperion intends to file similar patent infringement lawsuits under the Hatch-Waxman Act against the other ANDA Filers with respect to NEXLETOL and/or NEXLIZET, as applicable.
The ANDAs each contained Paragraph IV certifications alleging that certain of Esperion’s Orange Book listed patents covering NEXLETOL or NEXLIZET, as applicable, are invalid and/or will not be infringed by each ANDA Filer’s manufacture, use or sale of the medicine for which the ANDA was submitted.
Esperion intends to vigorously defend its intellectual property. The filing of the lawsuit within 45 days of receipt of the notice letter from the applicable ANDA filer triggered a stay of FDA approval of such ANDA for up to 30 months following the expiry of the New Chemical Entity exclusivity in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, statements related to anticipated patent infringement litigation. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, among others: fluctuations in the Company’s stock price, changes in market conditions, and the risks detailed in the Company’s filings with the Securities and Exchange Commission (the “Commission”), including in the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the Commission. Any forward-looking statements contained in this Current Report on Form 8-K speak only as of their respective dates, and the Company disclaims any obligation or undertaking to update or revise any forward-looking statements, other than to the extent required by law.
Item 9.01. Financial Statements and Exhibits.
| Exhibit No. | Description | |||||||
| 104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL. | |||||||
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.
| Date: May 8, 2024 | Esperion Therapeutics, Inc. | |||||||
| By: | /s/ Sheldon L. Koenig | |||||||
| Sheldon L. Koenig | ||||||||
| President and Chief Executive Officer | ||||||||