Current Report Filing (8-k)
October 25 2016 - 9:24AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): October 21, 2016
OPIANT PHARMACEUTICALS, INC.
(
Exact name of registrant as specified
in its charter)
Nevada
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000-55330
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46-4744124
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(State or other jurisdiction of incorporation)
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(Commission File Number
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(IRS Employer Identification No.)
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401 Wilshire Blvd., 12th Floor
Santa Monica, CA
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90401
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(Address of Principal Executive Offices)
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(Zip Cope)
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(424) 252-4756
Registrant’s telephone number, including
area code
(Former name or former address if changed
since last report,)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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On September 21, 2016, Opiant Pharmaceuticals, Inc. (the “Company”)
filed a Form 8-K announcing that it and Adapt Pharma Inc. (“Adapt Inc.”) received notice from Teva Pharmaceuticals
USA, Inc. (“Teva USA”), pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), that Teva USA, a wholly owned subsidiary of
and Teva Pharmaceuticals Industries Ltd. (“Teva Ltd.” and, together with Teva USA, “Teva”), had filed Abbreviated
New Drug Application No. 209522 (the “ANDA”) with the United States Food and Drug Administration (the “FDA”)
seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray before the expiration
of U.S. Patent No. 9,211,253 owned by the Company (the “’253 patent”). On October 21, 2016, Adapt Inc., Adapt
Pharma Operations Limited and the Company (collectively, the “Plaintiffs”) filed a complaint for patent infringement
against Teva in the United States District Court for the District of New Jersey arising from Teva USA’s filing of the ANDA
with the FDA. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ANDA be a date later
than the expiration of the ‘253 patent, as well as equitable relief enjoining Teva from infringing the ‘253 patent
and monetary relief as a result of any such infringement. The Company has full confidence in its intellectual property portfolio
related to NARCAN® (naloxone hydrochloride) Nasal Spray and expects that the ‘253 patent will continue to be vigorously
defended from any infringement.
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Opiant Pharmaceuticals, Inc.
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Date:
October 24, 2016
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By:
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/s/
Dr. Roger Crystal
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Name: Dr. Roger Crystal
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Title: President and Chief Executive Officer
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