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news.InSite Vision is set to file a lawsuit, along with Merck and Pfizer against Sandoz on generic version of AzaSite (azithromycin 1% ophthalmic solution).
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The decision follows Sandoz’s submission of an abbreviated new drug application (ANDA) seeking marketing authorization of the generic version of AzaSite before expiration of the patents covering AzaSite and its use.
AzaSite is marketed by Inspire Pharmaceuticals in the US, now a wholly-owned subsidiary of Merck.
Merck will take the lead in prosecuting this lawsuit and will defend five US patents of AzaSite with InSite and Pfizer.
InSite owns four US patents covering AzaSite and its use, and an exclusive license to a Pfizer-owned azithromycin patent.
Under the license agreement between InSite and Inspire, Inspire has the exclusive use of these patents in the US.