Pennsaid 2% is a follow-on product to original Pennsaid. Pennsaid 2% is a non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium compared to 1.5% for original Pennsaid. It is more viscous than original Pennsaid, is supplied in a metered dose pump bottle and has been approved in the U.S. for twice daily dosing compared to four times a day for Pennsaid. This provides Pennsaid 2% with advantages over Pennsaid and other competitor products, and with patent protection.
Pennsaid 2% has been licensed to Mallinckrodt, Inc. for the U.S. On January 16, 2014, the U.S. Food and Drug Administration (FDA) approved Pennsaid 2% for the treatment of pain of OA of the knee. Mallinckrodt launched Pennsaid 2% in the U.S. on February 10, 2014. Additional information for U.S. patients and physicians is available at www.pennsaid.com.
Pennsaid 2% has been licensed to Paladin Labs Inc. for Canada, South Africa, Israel and Central and South America and to NovaMedica LLC for Russia and some of the Community of Independent States. The product is not currently approved for sale or marketing in any of these countries.
The Company has filed patent applications to cover Pennsaid 2% and other related formulations in a number of jurisdictions worldwide. In the U.S., there are issued patents for Pennsaid 2% with expiry dates ranging from 2027 to 2028. In January 2014, the European Patent Office issued a patent that provides protection for the Pennsaid 2% formulation and its use. In 2014, the patent can be officially validated in over 37 countries. In addition, the Australian, Russian, South African and New Zealand patents covering Pennsaid 2% are granted and the Japanese patent application was allowed in 2013. There are additional patent applications pending in Brazil, Canada, China, the E.U., Hong Kong, India, Israel, Mexico and the U.S. that relate to the Pennsaid 2% franchise.