InSite Vision Incorporated (INSV) has reported that the US District Court for the District of New Jersey upheld all four of the patents protecting AzaSite, an azithromycin 1% ophthalmic solution, in a patent infringement lawsuit against Sandoz.
In 2011, Sandoz filed an Abbreviated New Drug Application (ANDA) for marketing a generic version of AzaSite before expiration of the patents covering the solution and its use.
In June 2013, a similar patent infringement lawsuit was filed against Mylan Pharmaceuticals, which filed an ANDA application for the solution with the FDA.
The lawsuit set off an automatic stay of the FDA's approval of the ANDA for about 30 months or until a final court decision of the infringement lawsuit, whichever comes first.
InSite owns its US patents covering the solution and its use as well as has an exclusive license to a Pfizer-owned azithromycin patent.
InSite Vision is developing new ophthalmologic products for unmet eye care needs based on its new DuraSite platform technologies.
The DuraSite platform is currently being used in two commercial products for the treatment of bacterial eye infections, AzaSite which is marketed by Merck in the US, and Besivance marketed by Bausch + Lomb.
