Impax Laboratories, Inc., a technology based specialty pharmaceutical company, and northern Colorado based Tolmar, Inc. have announced that the US Food and Drug Administration (FDA) has granted final approval of Tolmar’s Abbreviated New Drug Application (ANDA) for its generic version of Solaraze Gel (diclofenac sodium-3%). Tolmar was the first company to file a substantially complete ANDA containing a Paragraph IV certification, and Impax’s generics division, Global Pharmaceuticals, intends to commercialize this first-to-file product shortly. The last Orange Book listed patent expires August 11, 2015.

In June 2012, Impax Laboratories entered into a Development, Supply and Distribution Agreement (the Tolmar Agreement) with Tolmar, Inc. Under the terms of the Tolmar Agreement, Tolmar granted Impax an exclusive license to commercialize generic Solaraze in the United States and its territories. Under the terms of the Tolmar Agreement, Tolmar is responsible for developing and manufacturing the product, and Impax is responsible for the marketing and sale of the product.

According to IMS Health (NSP), US sales of Solaraze Gel three per cent were approximately $78 million for the 12 months ended September 2013.

Solaraze is a registered trademark of PharmaDerm, a Division of Fougera Pharmaceuticals Inc.

Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products.

Tolmar, Inc. is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company. Tolmar develops and manufacturers both proprietary and generic pharmaceutical products.