Sentences with phrase «abbreviated new drug applications»
Sandoz and other generic drug companies filed Abbreviated New Drug Applications seeking approval to market a generic form of the drug.
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Lex Machina's Patent Litigation Year in Review surveys and summarizes key trends that have emerged over the past year, drawing upon its platform that combines data from PACER, the Patent Trial and Appeal Board (PTAB), International Trade Commission (ITC), U.S. Food and Drug Administration (FDA) and Orange Book on Abbreviated New Drug Applications (ANDAs), among others.
Represented Dr. Reddy's Laboratories (DRL) against Celgene in Hatch - Waxman patent infringement litigation involving DRL's abbreviated new drug application to the FDA for a generic version of Revlimid (lenalidomide).
Daniel Attaway represents pharmaceutical and biotech patent holders in Abbreviated New Drug Application («ANDA») and related patent litigation.
Teva filed an Abbreviated New Drug Application seeking market approval for a generic form of Helsinn's product, and Helsinn responded by filing an infringement action asserting all four patents against Teva.
In particular, he counsels clients in Abbreviated New Drug Application (ANDA) cases under the Hatch - Waxman Act.
Patent holders previously made such claims in order to delay the onset of competition from generic drug manufacturers, by preventing or delaying FDA approval of a generic manufacturer's Abbreviated New Drug Application (ANDA).