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Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients today reported it has received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of a small private Chinese company. WhiteOak has filed an Abbreviated New Drug Application, or ANDA, with the FDA for a product claiming to be a generic of EXPAREL. Neither WhiteOak nor its parent company have any commercialized products. The parent company is Zhejiang Haichang Biotechnology Co Ltd.
In the PIV Notice, WhiteOak alleges that the claims of 19 EXPAREL patents listed in the FDA's Orange Book (U.S. Patent Nos.11,033,495, 11,179,336, 11,278,494, 11,304,904, 11,311,486, 11,357,727, 11,426,348, 11,452,691, 11,819,574, 11,819,575, 11,925,706, 12,144,890, 12,151,024, 12,156,940, 12,226,610, 12,251,468, 12,296,047, 12,318,483, 12,370,142) are invalid, unenforceable and/or will not be infringed by WhiteOak's manufacture, use or sale of the product described in its ANDA submission.
The company's contested Orange Book listed patents are primarily from two distinct patent families with the first family expiring on January 22, 2041, and the second family expiring on July 2, 2044.
Pacira intends to vigorously assert and enforce its intellectual property rights and has 45 days from receipt of the PIV Notice to file a lawsuit if it deems the ANDA filer is infringing its intellectual property. The lawsuit will trigger an automatic 30-month stay of FDA approval of White Oak's ANDA submission pursuant to the Hatch Waxman statute.
Posted In: PCRX
