US-based specialty pharmaceutical firm Impax Laboratories (Impax) has started shipment of generic Solaraze (diclofenac sodium gel, 3%), a first-to-file product, through its generics division Global Pharmaceuticals.
In order to commercialize generic Solaraze in the US and its territories, the company has an exclusive license from TOLMAR, which is the first company to file a substantially complete ANDA containing a Paragraph IV certification with the last Orange Book listed patent expiring 11 August 2015.
TOLMAR's ANDA is the first to secure approval from the US Food and Drug Administration (FDA).
Solaraze is a registered trademark of Fougera Pharmaceuticals division PharmaDerm.
Impax applies its formulation expertise and drug delivery technology to develop controlled-release and specialty generics in addition to the development of central nervous system disorder branded products.
The company also markets its generic products via its Global Pharmaceuticals division and its branded products through Impax Pharmaceuticals division.
