LAKE FOREST, Ill., Jan. 15, 2015 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market difluprednate ophthalmic emulsion 0.05%. If approved, Akorn's ANDA product would be a generic version of Alcon's Durezol®, which is a topical corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery as well as the treatment of endogenous anterior uveitis.
Alcon Laboratories, Inc., Alcon Pharmaceuticals Ltd., Senju Pharmaceutical Co. Ltd. and Mitsubishi Chemical Corporation filed suit against Akorn in the U.S. District Court of New Jersey on January 14, 2015 seeking to prevent Akorn from commercializing its ANDA product prior to the expiration of a U.S. Patent allegedly covering the branded product. The suit was filed under the provisions of the Hatch-Waxman Act, which may result in a stay of final FDA approval of Akorn's ANDA product for up to 30 months from the date the plaintiffs received notice of Akorn's ANDA filing or until final resolution of the litigation before the court, whichever occurs first, subject to any other regulatory exclusivities and potential court actions.
Based on information available to Akorn, the Company believes it may be a first applicant to file an ANDA for the generic version of Durezol®. Akorn believes that should its difluprednate ophthalmic emulsion 0.05% ANDA be approved, the Company may be entitled to 180 days of sole or shared generic market exclusivity for the label indication to which its ANDA is directed.
For the 12 months ending November 30, 2014, branded Durezol® had total U.S. sales of approximately $131 million, according to IMS Health data.
About Akorn, Inc.
Akorn, Inc. ("Akorn" or the "Company") is a specialty pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India where the Company manufactures ophthalmic, injectable and specialty non-sterile pharmaceuticals. Additional information is available on the Company's website at www.akorn.com.
Forward Looking Statements
This press release includes statements that may constitute "forward-looking statements", including projections of sales and other statements regarding Akorn's goals, regulatory approvals and strategy. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Factors that could cause or contribute to such differences include, but are not limited to: the difficulty of predicting the timing and outcome of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations; changes in the laws and regulations and such other risks and uncertainties outlined in Akorn's periodic public filings with the Securities and Exchange Commission and in other written or oral investor communications. Other factors besides those listed there could also adversely affect our results. Except as expressly required by law, Akorn disclaims any intent or obligation to update these forward-looking statements.
Durezol® is a registered trademark of Novartis AG.