According to the U.S. Food and Drug Administration, an unnamed company has filed the first generic drug application for Cialis, the erectile dysfunction treatment manufactured by Eli Lilly & Co.

The move is an example of the increasingly aggressive nature of generic companies in trying to push their products to the market. An application for generic drug certification may be filed as early as four years after FDA approval of the brand product. Cialis was approved on Nov. 21, 2003.

Although Cialis is protected by five patents which are not due to expire until between 2016 to 2020, its exclusivity expires in November 2008. A generic company could seek approval to market its version as long as Lilly’s patents are not infringed or made invalid.

Being the first to file for a generic Cialis could be significant because of market exclusivity for the first generic to be approved. The agency will review the application for up to 60 days. If it accepts the application, the generic firm must notify Lilly of its challenge.

Under the law, Lilly could sue the applicant for infringement within 45 days of that notice, putting an automatic 30-month stay on the approval of the generic drug. The drug manufacturer would then be protected from any harm that might result from the FDA granting marketing approval to a potentially infringing product.

The FDA doesn’t identify the filing company, or possibly multiple companies, and the legal process dictates that it could be months before it is revealed who made the filing.

Officials from Lilly weren’t immediately available to comment. Lilly recently reported 2007 sales of the Cialis of $1.14 billion, making it its fifth largest drug by sales.

This entry was posted on Wednesday, April 8th, 2009 at 1:34 pm and is filed under Cialis.