Arena Pharma (ARNA), Eisai Receive Paragraph IV Notification Related to Belviq
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Arena Pharma (NASDAQ: ARNA) disclosed the following on Thursday:
Item 8.01 Other Events.
We and Eisai Inc. have received a “Paragraph IV certification” notification with respect to patents for BELVIQ® (lorcaserin hydrochloride tablets, 10 mg) listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification was from an Abbreviated New Drug Application (ANDA) for a proposed generic version of BELVIQ®.
The notification is currently under investigation. In accordance with the Hatch-Waxman Act, we and Eisai have 45 days from the receipt of the notification to file a patent infringement suit against the ANDA filer which would result in the stay of FDA approval of the ANDA under statutory guidelines.
We and Eisai intend to vigorously defend our intellectual property rights. We cannot predict the outcome of any litigation matter.
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