Keflex® (cephalexin, USP) Products
In 2004 MiddleBrook™ Pharmaceuticals, Inc. established commercial operations through the acquisition of Keflex.
Keflex is a first-generation cephalosporin approved for treatment of several types of bacterial infections. Today, Keflex is the most-recognized brand of cephalexin in the United States, with more than 15 million prescriptions written each year. Keflex is the leading choice among physicians for treatment of uncomplicated skin infection. Although the majority of these prescriptions are substituted with generic cephalexin, Keflex brought in $4 million in net sales in 2003.
The acquisition of Keflex marks a significant step in our evolution to become a fully integrated pharmaceutical company. MiddleBrook has established distribution, sales and marketing capabilities to support Keflex that will also be instrumental in bringing our PULSYS-based products to market.
Keflex Line Extensions
The company has developed and filed application to FDA for approval of Keflex line extensions. If the line extensions are approved, they have potential to significantly increase Keflex product sales in the second half of 2006. We expect to deploy a community-based contract sales force in 2006 detailing physicians, including family practitioners and internists in support of Keflex and line extensions, pending regulatory approval.
PULSYS-enhanced Keflex
We are poised to begin clinical development of an enhanced Keflex product utilizing PULSYS™, our proprietary approach to once-a-day dosing. Our PULSYS-enhanced Keflex goals are to design a once-a-day version of cephalexin that will provide physicians a formulation that will potentially improve patient compliance and convenience while providing the efficacy that Keflex has historically provided. With the acquisition of Keflex, the path is clear for MiddleBrook to develop PULSYS versions of two of the top five most-prescribed antibiotics in the United States.
Keflex® Cephalexin Capsules
250mg, 500mg, and 750mg
Package Insert (PDF)
For further information on Keflex:
Please call 1-877-363-8080


