Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced that its recently issued U.S. patent related to GIMOTI, No. 11,628,150 is now listed in the U.S. Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the “Orange Book”.
The patent titled “Nasal Formulations of Metoclopramide” covers a collection of nasal solutions of metoclopramide and its characteristics when formulated. This new patent is now listed in the FDA’s Orange Book and carries a patent term to 2029. The listing of the patent in the Orange Book adds additional patent protection for GIMOTI beyond the prior two listed patents.
Patents listed in the Orange Book cover drugs that the FDA has approved and deemed both safe and effective for the general public’s use. Inclusion in the book’s list of patents can make it easier for drug makers to monitor for new generic drugs that could potentially arrive on the U.S. market and infringe on their patents.
“We are thrilled to be awarded another significant win on the intellectual property front through the listing of our recently granted GIMOTI patent, which will now be our third entry into the FDA’s Orange Book,” commented David Gonyer, Chief Executive Officer of Evoke Pharma. “This update adds to the list of confirmations from the USPTO regarding our patent estate and continues to affirm the novelty of GIMOTI. We remain committed to pursuing all measures to ensure the long-term availability of GIMOTI to patients who need this evidently important medication.”
