According to 2006 IMS data, this drug product has a total market size of approximately $750 million for all indications.
Under the terms of the exclusive ten-year agreement, Cipla will be responsible for the development, manufacturing and supply of the drug product. Akorn will be responsible for the clinical trial, ANDA regulatory submission and marketing and distribution in the US and Puerto Rico.
Akorn will pay Cipla milestone fees for the ANDA development and Akorn will own the ANDA. Akorn expects to launch the product in late 2009. Pursuant to the agreement, Akorn and Cipla will share net revenues on a 60:40 basis, respectively.