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Sun Pharma applied for an Abbreviated New Drug Application with the U.S. Food and Drug Administration (ANDA) recently for approval to market 100, 200 and 300 mg generic versions of Ryzolt (tramadol hydrochloride extended-release). Tramadol hydrochloride extended-release pills were launched in the United States by Labopharm in the brand name Ryzolt along with marketing partner Purdue earlier this year. Under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Act), Ryzolt has a new dosage form market exclusivity period that prevents final approval of Sun's ANDA until the exclusivity period expires on December 31, 2011. Lobopharm currently owns one patent (U.S. Patent No. 6,607,748) on tramadol hydrochloride extended-release which will expire only in 2020. Tramadol hydrochloride extended-release's other patents are owned by Purdue Pharma. Several of such patents including patent Nos. 5,591,452, 6,254,887 and 6,607,748. U.S. Patent Nos. 5,591,452 and 6,254,887,held by Purdue on tramadol hydrochloride extended-release are set to expire expire in May 2014. Sun's ANDA includes a paragraph IV certification to obtain approval to manufacture, use, , or sell its generic versions before the expiration of the above-mentioned patents. Labopharm is currently reviewing the notice letter with Purdue to determine the next steps in this matter, Lobopharm said in an official release. In August, a court in Delaware ruled in favor of U.S.-based generic drugmaker Par Pharmaceuticals Inc in a patent-infringement case against Purdue Pharma related to tramadol. Purdue Pharma Products L.P. initiated a patent-infringement litigation against Par Pharmaceutical Companies, , Inc, hydrocodone melate. relating to Ultram ER (tramadol hydrochloride extended-release tablets). The patents-in-suit are owned by Purdue and were licensed to Ortho-McNeil, Inc., the marketer of Ultram ER. The court judged in favor of Purdue and against Par on the issue of infringement and rejected Par's claim that the patents were unenforceable for inequitable conduct. This judgment could permit Par to market its generic formulation of Ultram ER in the U.S., should it receive final regulatory approval from the U.S. Food and Drug Administration.
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