Akorn (AKRX) Receives Favorable PTAB Ruling Over Durezol IPR Proceeding
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Akorn, Inc. (Nasdaq: AKRX) announced that on November 22, 2016, the Patent Trial and Appeal Board (PTAB) ruled in favor of Akorn in its inter partes review (IPR) proceeding and found all the claims of the 6,114,319 patent (“ ‘319 patent”) related to the Durezol formulation to be obvious. The ‘319 patent, directed to emulsions of difluprednate, is owned by Senju Pharmaceutical Co., Ltd. and Mitsubishi Chemical Corporation, and licensed to Alcon Laboratories, Inc.
Raj Rai, Akorn’s Chief Executive Officer, commented, “We welcome the PTAB’s deliberate and thorough decision which took into consideration all the evidence presented, including evidence of secondary considerations presented by Patent Owner. This is an exciting opportunity for our Company as we believe we will be eligible for sole marketing exclusivity pending receipt of final FDA approval. This outcome will help us reach our goal of achieving a leadership position in generic ophthalmics and further solidifies our strategic focus on alternate dosage forms such as ophthalmics, injectables and topicals.”
Akorn believes it is the first and only company to file a substantially complete abbreviated new drug application containing a Paragraph IV certification and expects to benefit from 180 days of marketing exclusivity in the U.S. upon final FDA approval.
U.S. sales of Durezol® (difluprednate ophthalmic emulsion) 0.05% were approximately $191 million for the 12 months ending September 30, 2016, according to IMS Health.
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