Elite Pharmaceuticals Inc (ELTP)

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IPCI had challenged Purdue's Oxycontin ER Patents directly as apparently IPCI does not fear a legal battle with Purdue.

Intellipharmaceutics Announces Patent Litigation by Purdue against its Rexista™ Abuse-Deterrent Extended-Release Oxycodone
GLOBENEWSWIRE 8:00 AM ET 4/10/2017
Symbol Last Price Change
IPCI 1.9701up -0.3099 (-13.59%)
QUOTES AS OF 12:00:44 PM ET 04/10/2017
TORONTO, April 10, 2017 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F. Laboratories, Inc. (collectively, “Purdue”), Rhodes Technologies, and Grünenthal GmbH (collectively, “plaintiffs”) have commenced patent infringement proceedings against the Company in the United States District Court for the District of Delaware in respect of the Company’s New Drug Application (“NDA”) filing for its Rexista™ product candidate (abuse-deterrent oxycodone hydrochloride extended release tablets) with the United States Food and Drug administration (“FDA”).


Intellipharmaceutics (IPCI) had previously filed its NDA for its RexistaTM product candidate on November 24, 2016, relying on the 505(b)(2) regulatory pathway, which allowed us to reference data from Purdue’s OxyContin® extended release oxycodone hydrochloride then in the market in the U.S. The RexistaTM application was accepted by the FDA for further review on February 1, 2017. The Company then certified to the FDA that it believed that its RexistaTM product would not infringe any of the sixteen (16) patents owned by one or more of the plaintiffs, or that such patents are invalid, and it so notified the plaintiffs of such certification. On April 7, 2017, the plaintiffs filed the above-noted legal proceedings, alleging that RexistaTM infringes six (6) out of the sixteen (16) patents.

By reason of the commencement of these legal proceedings, the FDA is stayed for 30 months from granting final approval to the Company’s RexistaTM abuse-deterrent oxycodone. That time period commenced on February 24, 2017, when the plaintiffs were notified of the Company certification concerning the patents, and will expire on August 24, 2019, unless the stay is earlier terminated by a final declaration of the courts that the patents are invalid, or are not infringed, or the matter is otherwise settled among the parties.

Dr. Isa Odidi, CEO and Co-Chief Scientist of the Company, stated, “Contesting litigation of this nature is part of what it takes to compete for the right to market valuable novel drug products in the United States. We have engaged highly regarded patent counsel with substantial directly applicable experience. We believe that we do not infringe the subject patents and that we have a well-prepared strategy to vigorously defend the Company against these claims.”