Making progress in the fight against opioid abuse, California-based Opiant Pharmaceuticals Inc. recently obtained a U.S. patent for its 2mg formula of Narcan Nasal Spray and product inclusion in U.S. Food and Drug Administration’s listings.
The FDA’s regular publication — Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book — now features a half-dozen patents for Narcan, Opiant spokespersons said.
“We are pleased with this new patent issuance and subsequent Orange Book listing,” Opiant CEO Dr. Roger Crystal said. “We now have six Orange Book-listed patents for Narcan, and remain encouraged by our solid intellectual property position and enhanced product exclusivity. This latest patent also has the potential to be relevant to other products in development by Opiant.”
Opiant’s formulation attained FDA approval in January. The new patent relates to Narcan as adapted for nasal administration using a pre-primed device containing an opioid receptor antagonist. Additionally, it provides for methods of treating opioid overdose or related symptoms with the 2mg formulation.
Company officials added that as with any Orange Book listing, any pharmaceutical companies desiring to create a generic version of Opiant’s product would be required to notify the FDA prior to development and/or application for an Abbreviated New Drug Application.
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