Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) reported its shares progressed Tuesday, on word that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,793,813 entitled “Pemetrexed Formulations.” Eagle has submitted the patent for listing in the U.S. Food and Drug Administration’s Orange Book.1 The ‘813 patent is directed to pemetrexed formulations, including the FDA-approved commercial formulation of PEMFEXY®.
The ‘813 patent will expire in 2036. This is the second patent to be listed in the Orange Book for PEMFEXY, and to date Eagle has not received any notice of a Paragraph IV certification for an application referencing PEMFEXY.
“The issuance of this patent is meaningful, as we continue to vigorously protect the commercial success of PEMFEXY and to add to the overall strength of our patent portfolio. PEMFEXY maintains a unique J-Code from CMS and sales remain strong, with a 24% share in the commercial (non-340B) pemetrexed market leaving the third quarter of 2023,” stated CEO Scott Tarriff.
“PEMFEXY,” according to this morning news release, “is a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin.”
EGRX shares were better at the outset 14 cents, or 1.1%, to $13.35.