Impax Laboratories, Inc. (NASDAQ: IPXL) and TOLMAR, Inc. today announced that the U.S. 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), U.S. sales of Solaraze® Gel 3% were approximately $78 million for the 12 months ended September 2013.
Solaraze® is a registered trademark of PharmaDerm, a Division of Fougera Pharmaceuticals Inc.About Impax Laboratories, Inc. Impax Laboratories, Inc. (Impax) 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. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. For more information, please visit the Company's Web site at: www.impaxlabs.com. About TOLMAR, Inc. 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. TOLMAR provides its customers with a competitive and sustainable combination of product development and commercial services. The company’s strengths include a proven development, clinical, regulatory and manufacturing infrastructure with a highly trained and experienced staff. Several of its marketed products are still in an early stage growth mode. TOLMAR products are commercialized through marketing partners in over fifty five countries worldwide, including North America and Europe.