UNITED STATES
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CURRENT REPORT
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| Item 8.01. | Other Events. |
On December 18, 2023, Heron Therapeutics, Inc. (the “Company”) received a paragraph IV certification notice (the “Notice”) from Mylan Pharmaceuticals Inc. (“Mylan”) advising that Mylan filed with the U.S. Food and Drug Administration (“FDA”) an Abbreviated New Drug Application (“ANDA”), seeking approval to manufacture, use or sell a generic version of the Company’s product APONVIE® (aprepitant) in the United States prior to the expiration of U.S. Patents Nos. 9,561,229; 9,808,465; 9,974,742; 9,974,793; 9,974,794; 10,500,208; 10,624,850; 10,953,018; 11,173,118 and 11,744,800 (the “Challenged Patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange Book” and each of which expire September 18, 2035. The Notice alleges that the Challenged Patents are invalid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of the generic product described in the ANDA. The Company is currently reviewing the Notice and intends to vigorously defend and enforce its intellectual property rights protecting APONVIE®. As of the date of this filing, the Company is not aware of any other ANDA filers.
In accordance with the Hatch-Waxman Act, because APONVIE® is a new chemical entity, should the Company file a patent infringement lawsuit within 45 days of receipt of the Notice, the FDA cannot approve Mylan’s ANDA any earlier than 7.5 years from the approval of the APONVIE® NDA unless a District Court finds that all of the asserted claims of the patents-in-suit are invalid, unenforceable and/or not infringed.
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.
| Heron Therapeutics, Inc. | ||||||
| Date: December 22, 2023 | /s/ Ira Duarte | |||||
| Ira Duarte | ||||||
| Executive Vice President, Chief Financial Officer | ||||||