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Investing.com -- Pacira BioSciences Inc. (NASDAQ:PCRX) stock fell 6% on Tiesday after the company disclosed it received a Paragraph IV Certification Notice Letter from The WhiteOak Group, challenging patents for its flagship EXPAREL drug.
The notice indicates WhiteOak, a subsidiary of Chinese company Zhejiang Haichang Biotechnology Co Ltd, has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval for a generic version of EXPAREL, Pacira’s non-opioid pain management therapy.
According to Pacira’s statement, WhiteOak alleges that claims in 19 EXPAREL patents listed in the FDA’s Orange Book are "invalid, unenforceable and/or will not be infringed" by WhiteOak’s product. The contested patents belong to two distinct families, with expiration dates of January 22, 2041, and July 2, 2044, respectively.
Pacira noted that neither WhiteOak nor its parent company currently have any commercialized products. The company has 45 days from receipt of the notice to file a lawsuit if it believes WhiteOak is infringing on its intellectual property.
If Pacira pursues legal action, it would trigger an automatic 30-month stay of FDA approval for WhiteOak’s ANDA submission under the Hatch-Waxman statute. Pacira stated it "intends to vigorously assert and enforce its intellectual property rights" related to EXPAREL.
EXPAREL is Pacira’s leading product, a long-acting local analgesic that has been central to the company’s position as a provider of non-opioid pain management solutions.
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