Santa Monica, California, October 27, 2016 (Globe Newswire) – Operant Pharmaceuticals, Inc. (“OPTIC”) (OTCQB: OPTION), a special drug company to develop medicinal remedies for the use of substance, Announcement of addiction and eating disorders today, which is now given in the publication of the American Food and Drug Administration (FDA) for NARCAN® Nassal Spray (“NARCAN”), approved Drug Products in Medical Equalience Evaluation, Those commonly known as Orange Books, Patent number 9468747. The patent for naloxone hydrochloride metered 4 miligram nasal spray,N208411, offers product exclusivity for NARCAN until 2035.
Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders. Over 45 million people in the U.S. have one of these disorders. The National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, the opposition is positioned to become a leader in these treatment markets. Its first product, NARCAN® Nassal Spray, is a company partner, Adapt Pharma Limited by the U.S. Is marketed in. At present, the use of opposition disorders and cocaine is developing opioid antioxidants for the treatment of the use of substances, addiction and eating disorders with the closest attention to eating disorder.
About patent
Patent No. 9,629,965 –Title ( Nasal druge product methods of their use ), Drug product adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.
Patent conflict
Operator Chief Executive Officer, Roger Crystal, MD, said, “Our intellectual property is strong enough to issue this patent and after that in the Orange Book listing.” “Orange Book Listing requires a brief New Drug Application (ANA) applicant who is seeking FDA approval for the general version of NARCAN® Nassal Spray to inform us and our partner Adamp Pharma before receiving FRA approval. This will be subject to marketing approval of 30 months and if there is information, then it will likely be more and the case of patent infringement will be successful. ”
The opposition successfully developed Narcán for marketing by its partner and licensee, Adapt Pharma Limited (“Adapt”). In November 2015, NARCON was approved by the FIDA for the emergency reversal of Opioid Overdose.
“Now two Orange Books are listed patents that cover NARCAN® Nasal Spray. It is a comprehensive applicability in the portfolio of the Opposition recently,” Dr. Crystal said. “We will continue to create more intellectual property relevant to both Narcan® Nasal Spray and our development pipeline.”
In December 2014, Viipers announced a licensing deal in relation to Narkan with optimization. According to the terms of the agreement, the operator can get a potentially more successful milestone payment of more than $ 55 million, as well as double-digit royalties on net sales.
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