Making a World of Difference

Generic Division

URL Pharma's generic segment encompasses multiple aspects of the generic value-chain including formulation development, manufacturing, and distribution. We utilize state of the art technology to maximize flexibility, profitability and quality control. URL Pharma has 288 ANDA (FDA generic) approvals across diverse therapeutic classes, and manufactures over 100 different capsule and tablet products.

 

Our most successful generic product has been felodipine, the generic version of AstraZeneca’s Plendil®. Due to the scientific complexities surrounding felodipine, URL Pharma remained the exclusive generic manufacturer of this product from 2004 until early 2008, well past brand patent expiration and the expiration of our 6 month FDA exclusivity period. Recently, URL Pharma became the first-to-file generic version of GSK’s Coreg CR™.  We expect at least 6 months of generic exclusivity on this product too.

 

In May, 2008, we had 8 applications pending at the FDA which have a brand value of 2.2B per IMS in the most recent 12 month period. In addition, we have multiple other products under development. However, the size of brand markets do not reliably predict the profitability of the corresponding generic versions due to intense commodity market pricing pressures on generics with multiple generic FDA approvals.

 

To address this issue, URL Pharma achieves multiple ANDA filings per year and focuses exclusively on either Paragraph IV patent challenges, highly-complex formulations, or generic products that require clinical studies. This is consistent with our strategy to maintain pricing power beyond what is possible in the commodity generic marketplace.