Opiant Pharmaceuticals, Inc. Announces FDA Orange Book Listing for New NARCAN Nasal Spray Patent

Opiant Pharmaceuticals (NASDAQ:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions and drug overdose, today announced that its most recently issued U.S. Patent, No. 10,085,937, covering methods of use for the four-milligram formulation of NARCAN Nasal Spray for the treatment of opioid overdose, 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.

As quoted in the press release:

“We are pleased to further strengthen our intellectual property surrounding NARCAN with the issuance of this patent and Orange Book listing,” said Roger Crystal, M.D., Chief Executive Officer of Opiant.  “We now have eight Orange Book-listed patents for NARCAN, five of which cover the 4 mg formulation.”

U.S. Patent No. 10,085,937 claims nasal spray formulations and methods of treatment covering the 4 mg dose of NARCAN. The patent provides for drug products adapted for nasal delivery via a pre-primed device filled with a pharmaceutical composition containing an opioid receptor antagonist. The patent also provides for methods of treating opioid overdose or its symptoms with the 4 mg formulation of NARCAN. An Orange Book listing requires an Abbreviated New Drug Application applicant seeking FDA approval of a generic version of NARCAN to notify Opiant and its partner, Adapt Pharma Limited, a subsidiary of Emergent Biosolutions Inc., before it can obtain FDA approval. This would be subject to a 30-month stay of marketing approval and potentially longer if such notification occurs and a patent infringement suit is successful.

Click here to read the full press release.