InSite Vision Incorporated, a California-based company develops novel ophthalmic products designed to treat a growing range of common eye problems, announced that the United States District Court for the District of New Jersey upheld all four of the patents protecting AzaSite (azithromycin 1% ophthalmic solution) in a patent infringement lawsuit against Sandoz Inc.

Sandoz filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA ) in 2011 seeking to market a generic version of AzaSite before expiration of the patents covering AzaSite and its use. AzaSite is marketed in the US by Inspire Pharmaceuticals, a subsidiary of Merck.

In June 2013 a similar patent infringement lawsuit was filed against Mylan Pharmaceuticals. A trial date in this matter has not been set.

Mylan filed an ANDA application for AzaSite with the FDA of which InSite received notice on May 2, 2013, and InSite had 45 days to file a patent infringement lawsuit. This lawsuit triggered an automatic stay, or bar, of the FDA’s approval of the ANDA for up to 30 months or until a final court decision of the infringement lawsuit, whichever comes first.

InSite owns its US patents covering AzaSite and its use, and an exclusive license to a Pfizer-owned azithromycin patent.

InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing the frequency of treatment and improving the efficacy of topical drugs.