Akorn to challenge Durezol patent

Akorn, Inc., confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration to produce a generic version of Alcon’s topical corticosteroid, Durezol.

The generic and branded products are indicated for treating inflammation and pain associated with ocular surgery, as well as treating endogenous anterior uveitis.

Alcon this week filed a lawsuit seeking to prevent Akorn from commercializing its product prior to the expiration of a U.S. patent allegedly covering the branded product.  

If approved, Akorn believes it may be entitled to 180 days of sole or shared generic market exclusivity‎ for the approved indication.