The efficacy results presented were confirmed in a study published in 2007.Nevanac was approved by the FDA on August 19, 2005, with application number 021–862. Ilevro
An NDA for Ilevro was filed on December 15, 2011. In a one-month study, no new toxicities arose in the new formulation of nepafenac. Safety and efficacy information was derived from the previous Nevanac application. In June 2010, a confirmatory study began (Study C09055) consisting of over 2000 patients from 49 US sites and 37 European sites. A second phase 3 trial (Study C11003) was conducted in a population of 1,342 patients at 37 sites across the United States which failed to demonstrate superiority over Nevanac in an altered dosing regimen.Ilevro was approved by the FDA on October 16, 2012, with application number 203–491. Commercialization
Both Nevanac and Ilevro are manufactured and sold by Alcon, Inc. Alcon is currently a division of Novartis International AG, which is primarily based out of Switzerland. Alcon, Inc. also holds locations in both Switzerland and the United States. The company has gone through several name changes, from Alcon Laboratories, Inc. to Alcon Universal, Ltd., to Alcon, Inc.Nevanac entered the market in 2005 as a product of Alcon, at the time a subsidiary of Nestlé. On April 6, 2008, Novartis agreed to purchase approximately 74 million shares of Alcon from Nestlé at $143.18 per share. On January 4, 2010, Novartis agreed to purchase all remaining shares of Alcon from Nestlé, totalling 156 million shares or 77% of the shares in the company.
Novartis also notes the influence of position and preference on US Centers for Medicare & Medicaid formularies in expanding their market value.Nepafenac, Nevanac, and Ilevro are all absent from the 2016 Annual Report issued from Novartis. Intellectual property
There are currently seven U.S. patents filed that are directly associated with the modernized formulations of nepafenac, all stemming from Novartis. There are three patents associated with Nevanac that are still active and four associated with Ilevro. The earliest patent related to the modern formulations of nepafenac was approved on June 11, 2002, after being filed in 1999, by Bahram Asgharian. A patent was filed by Warren Wong, associated with Alcon, Inc. based out of Fort Worth, Texas, on December 2, 2005, for aqueous suspensions of nepafenac. Another patent for a nepafenac-based drug was filed on May 8, 2006, by Geoffrey Owen, Amy Brooks, and Gustav Graff. A patent was filed by Masood A. Chowhan and Huagang Chen on February 9, 2007, and approved on May 24, 2011, followed closely by a patent filed by Warren Wong on September 23, 2010, and approved on December 6, 2011. Masood A. Chowhan, Malay Ghosh, Bahram Asgharian, and Wesley Wehsin Han filed another patent on December 1, 2010, and approved on December 30, 2014. The most recent patent was filed by Masood A. Chowhan, Malay Ghosh, Bahram Asgharian, and Wesley Weshin Han on November 12, 2014, and approved on May 30, 2017.