Labopharm receives notice of ANDA submission with paragraph IV certification
for generic of Ryzolt(TM)
LAVAL, QC,
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
Sun's ANDA includes a paragraph IV certification to obtain approval to manufacture, use, or sell its generic versions before the expiration of Patent Nos. 5,591,452, 6,254,887 and 6,607,748. U.S. Patent Nos. 5,591,452 and 6,254,887, which are owned by Purdue Pharma Products L.P., Labopharm's marketing and distribution partner in the US, expire in
Labopharm is currently reviewing the notice letter with Purdue to determine the next steps in this matter.
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is now available in 17 countries around the world, including the U.S.,
Ryzolt(TM) is a trademark of Purdue Pharma Products L.P.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Except as required by law, the Company undertakes no obligation and does not intend to update these forward-looking statements.
For further information: At Labopharm: Mark D'Souza, Senior Vice-President and Chief Financial Officer, Tel: (450) 686-0207; At The Equicom Group: Jason Hogan, Media and Investor Relations, Tel: (416) 815-0700, [email protected]; French: Joe Racanelli, Tel: (514) 844-7997, [email protected]
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