CALCITONIN SALMON (Fortical): Court blocked Apotex’s generic version till final decision on validity and infringement of formulation patent

Innovator Unigen announced (Here) that United States District Court for the Southern District of New York entered a preliminary injunction against generic player Apotex from launching generic version of Unigen and UPSHER SMITH’s CALCITONIN SALMON 200 IU/SPRAY (Fortical) in U.S market, till court decide the validity and infringement of following Orange Book listed patent:
US6440392 (Expiry: Feb 2, 2021): Which covers a liquid pharmaceutical composition comprising calcitonin or an acid addition salt thereof and citric acid and/or salt thereof in a concentration from 10 to about 50 mM, said composition being in a form suitable for nasal administration.
Apotex filed its ANDA with Paragraph IV certification against ‘392 in 2006, subsequently, innovator sued Apotex in New York district court, accordingly, ANDA approval process of Apotex was blocked for 30 months. After the expiry of 30 months stay on ANDA approval, Apotex received final approval from USFDA on Nov 17, 2008 and was ready to launch this product in US market at risk.
Earlier, USFDA approved innovator UPSHER SMITH’s Fortical formulation on Aug 12, 2005