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News Breaks
January 25, 2013
05:13 EDTRDYDr. Reddy's announces the launch of Desloratadine ODT
Dr. Reddy's Laboratories announced that it has launched Desloratadine Orally Disintegrating Tablets, or ODT, a bioequivalent generic version of Clarinex Reditabs in the US market on January 24. Dr. Reddy's ANDA for Desloratadine ODT is approved by the FDA. The Clarinex Reditabs brand had U.S. sales of approximately $5.3M for the most recent twelve months ending November 2012, according to IMS Health.
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August 7, 2014
13:55 EDTRDYTeva won't be meaningfully hurt soon by new Copaxone filing, says BMO Capital
After Teva (TEVA) confirmed that it received the first paragraph IV notice for the 3x per week version of its Copaxone drug from Dr. Reddy's (RDY), BMO Capital said it had expected companies to seek to market a generic version of the latest Copaxone formulation, but was surprised that Dr. Reddy's took this action. The firm notes that Teva's decision to file a lawsuit against Dr. Reddy over the application will trigger a 30 month stay of approval of the generic version,. BMIO Capital says that investors should keep this issue on their radar, but the firm does not expect Teva to be meaningfully hurt in the near-term by this development. It keeps an Outperform rating on Teva.
12:06 EDTRDYTeva will continue to defend COPAXONE intellectual property rights
Teva (TEVA) confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE 40 mg/mL product from Dr. Reddy’s Laboratories (RDY). Teva will continue to vigorously defend its COPAXONE intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Dr. Reddy’s within the 45 day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30 month stay of FDA approval of Dr. Reddy’s ANDA. COPAXONE 40 mg/mL is protected by two Orange Book patents that expire in 2030.

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