EXEL
Ahora parece que sí es oficial
received a Paragraph IV Certification Notice Letter from MSN Pharmaceuticals, Inc. (“MSN”) that MSN had filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) for a generic version of CABOMETYX® (cabozantinib) tablets (20 mg / 40 mg / 60 mg) (the “Notice”).
The Notice states that MSN intends to market a generic version of CABOMETYX before the expiration of Exelixis’ U.S. Patent Nos. 8,877,776, 9,724,342, 10,034,873 and 10,039,757, all of which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book (the “Subject Patents”). The Notice does not challenge the CABOMETYX composition of matter patent No. 7,579,473, which expires on August 14, 2026. The Notice alleges that the Subject Patents are invalid, unenforceable and/or will not be infringed by MSN’s commercial manufacture, use or sale or the subject drug products.
Exelixis currently is reviewing the Notice. The Company intends to vigorously enforce its intellectual property rights relating to CABOMETYX, but cannot predict the outcome of this matter. CABOMETYX is protected by six issued patents in the United States, all of which are listed in the Orange Book.
«Después de nada, o después de todo/ supe que todo no era más que nada.»