Three generic drug-makers have filed regulatory applications (as reported by newsobserver here) to make cheaper versions of Elestat, an allergy medicine made by Allergan and sold by Inspire Pharmaceuticals of Durham.
The Generic players have filed ANDA with Para IV certification against following Orange Book listed patent:
US7429602 (Issued on: September 30, 2008, Expiry: Nov 29, 2020): A method for treating allergic conjunctivitis, comprising topically administering to the conjunctiva of a host in need of such treatment a solution comprising: (a) a pharmaceutically active ingredient consisting essentially of Epinastine, optionally in the form of its racemate, or an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in a concentration of 0.005 to 0.5 mg/ml of solution; (b) water or physiologically acceptable saline; and (c) a preservative, optionally also including one or more chelating agents, viscosity agents, penetration promoters, antioxidants, substances to adjust the tonicity of the solution, or a physiologically acceptable buffer. Innovator
Allergen got approval to market this product on Oct 16, 2003. Further, there are chances that innovator sue the companies who have filed Para IV against said patent to block the ANDA approval for 30 months.
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