WASHINGTON (dpa-AFX) - Pharmaceutical company Akorn Inc (AKRX) on Thursday said it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration 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 Corp filed suit against Akorn in the U.S. District Court of New Jersey on Wednesday, 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.
Akorn believes it may be a first applicant to file an ANDA for the generic version of Durezol, and 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.
For the 12 months ending November 2014, branded Durezol had total U.S. sales of about $131 million, according to IMS Health data.
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