Impax Labs. Introduces Generic Solaraze - Quick Facts

(RTTNews) - Impax Laboratories, Inc. (IPXL) said it is commencing shipment of generic Solaraze, a first-to-file product, through Global Pharmaceuticals, Impax's generics unit. Impax was awarded an exclusive license by TOLMAR, Inc. to commercialize generic Solaraze in the U.S. and its territories.

TOLMAR was the first company to file a substantially complete ANDA containing a Paragraph IV certification with the last Orange Book listed patent expiring August 11, 2015. TOLMAR's ANDA is the first to get U.S. Food and Drug Administration approval.

According to IMS Health, U.S. sales of Solaraze Gel, 3%, were nearly $78 million for the year ended September 2013. Solaraze is a registered trademark of PharmaDerm, a division of Fougera Pharmaceuticals Inc.