Wednesday, May 08, 2024 10:29:14 PM
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.
Recent ESPR News
- Bempedoic Acid Met Primary Endpoint of Phase 3 Trial in Japan for the Treatment for Hypercholesterolemia • GlobeNewswire Inc. • 05/20/2024 10:00:00 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/17/2024 07:08:17 PM
- Esperion Receives Five Year Patent Extension for Bempedoic Acid, Contained in NEXLETOL® and NEXLIZET® • GlobeNewswire Inc. • 05/14/2024 12:00:00 PM
- Esperion Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 05/10/2024 08:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 08:31:21 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/07/2024 12:50:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/07/2024 11:29:53 AM
- Esperion Reports First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/07/2024 10:00:00 AM
- Esperion to Participate in Upcoming May Investor Conferences • GlobeNewswire Inc. • 04/29/2024 12:00:00 PM
- Esperion to Report First Quarter 2024 Financial Results on May 7 • GlobeNewswire Inc. • 04/23/2024 12:00:00 PM
- Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity • GlobeNewswire Inc. • 04/07/2024 06:45:00 PM
- Esperion to Ring Nasdaq Opening Bell Today, April 1, 2024 • GlobeNewswire Inc. • 04/01/2024 12:00:00 PM
- Esperion to Participate in 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/26/2024 12:00:00 PM
- Esperion Announces Data from CLEAR Outcomes Sub-Groups as Poster Presentations, Moderated Session & Industry Expert Theatre to be Presented at ACC.24 • GlobeNewswire Inc. • 03/25/2024 08:00:00 PM
- U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use • Business Wire • 03/22/2024 10:26:00 PM
- U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use • GlobeNewswire Inc. • 03/22/2024 07:10:20 PM
- CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events • GlobeNewswire Inc. • 03/22/2024 03:04:39 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/27/2024 02:19:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/27/2024 12:23:29 PM
- Esperion Reports Fourth Quarter and Full Year 2023 Financial Results • GlobeNewswire Inc. • 02/27/2024 11:00:00 AM
- Esperion Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 02/16/2024 09:30:00 PM
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