Activery The amorphization specialist
Activery believes that amorphous drugs provide new and innovative routes to final dosage forms with differentiated pharmacokinetics
| Labopharm receives notice of ANDA submission with paragraph IV certification for generic of Ryzolt |
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| Labopharm today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 100, 200and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochlorideextended-release 100, 200 and 300 mg tablets) in the United States.Under the Drug Price Competition and Patent Term Restoration Act (known as theHatch-Waxman Act), Ryzolt has a new dosage form market exclusivity period thatprevents final approval of Sun's ANDA until the exclusivity period expires onDecember 31, 2011.Sun's ANDA includes a paragraph IV certification to obtain approval tomanufacture, use, or sell its generic versions before the expiration of PatentNos. 5,591,452, 6,254,887 and 6,607,748. U.S. Patent Nos. 5,591,452 and6,254,887, which are owned by Purdue Pharma Products L.P., Labopharm'smarketing and distribution partner in the US, expire in May 2014. U.S. Patent# 6,607,748, which is owned by Labopharm, expires in June 2020. All threepatents are listed in the FDA's Approved Drug Products with TherapeuticEquivalence Evaluation (the "Orange Book").Labopharm is currently reviewing the notice letter with Purdue to determinethe next steps in this matter. |
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