Teva`s Generic Metoclopramide Receives Approval in the U.S.
Evoke Pharma, Inc., a specialty pharmaceutical company focused primarily on treatments for GI diseases with an emphasis on Gimoti (metoclopramide) nasal spray, announced the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for US Application No. 17/100,664 for Gimoti. Once issued, the patent, entitled “Nasal Formulations of Metoclopramide” will expire in December 2029. This patent application is a continuation of several other US patent applications filed by the company over the last decade.
Enforcement Report - Week of August 25, 2021
Evoke Pharma announced that its US patent No. 11,020,361 for Gimoti (metoclopramide) nasal spray is now listed in the US Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the “Orange Book”. The patent covers methods of use for nasal delivery of metoclopramide for the treatment of gastroparesis.
Enforcement Report - Week of March 10, 2021
Over a year after the FDA first rebuffed Evoke’s application, the agency has approved the small biotech’s lone drug, a treatment for a common gastrointestinal complication of diabetes.
Over a year after the FDA first rebuffed Evoke’s application, the agency has approved the small biotech’s lone drug, a treatment for a common gastrointestinal complication of diabetes.
As one of the handful of drugs-in-development for gastroparesis, Vanda Pharmaceuticals’ $VNDA tradipitant has set itself apart for the condition that affects about 6 million in the United States and has not seen an approval in nearly four decades. On Monday, the drugmaker released mid-stage data that impressed, showing the drug conferred a statistically significant improvement in nausea symptoms and nausea-free days.
Evoke Pharma has selected Patheon to commercially manufacture its nasal delivery formulation of metoclopramide Gimoti ahead of a planned US FDA submission next year.