Dabur Pharma and Dabur Oncology Pte., UK submits to ANDAs with FDA

Dabur Pharma Ltd has announced that the Company and Dabur Oncology Pte., UK submitted two Abbreviated New Drug Applications (ANDAs), with Para-IV Certifications with the U.S. Food and Drug Administration (US FDA) seeking Marketing Approval for Generic Versions of Eloxatin®, which contains the Active ingredient, Oxaliplatin. Eloxatin® which is marketed by Sanofi-Aventis, as an injectable, is used in treatement of bowel cancer and generated sales of approximately 1.7 billion Euros (US $ 2.3 billion). Generic versions of Eloxatin (Oxaliplatin) are available in several European Markets.

In response to the Patent challenge made by the Company and Dabur Oncology plc, Sanofi-Aventis U.S. LLC, Sanofi-Aventis and Debiopharm, S.A. have filed a lawsuit against Dabur Oncology plc and the Company in the United States District Court for the District of New Jersey in connection with Dabur Oncology plc's filing of ANDAs with the U.S. FDA seeking approval to market Generic Oxaliplatin products. The Complaint alleges that the filing of the Applications has infringed, and the proposed products will infringe, U.S. Patent No. 5,338,874 and U.S. Patent No. 5,716,988.

The Company and Dabur Oncology plc dispute the charges of infringement and intend to vigorously challenge these allegations and are confident of asserting non-infringement of U.S. Patent No. 5,338,874 and U.S. Patent No. 5,716,988.

The stock closed the day at Rs.80.65, up by Rs.1 or 1.26%. The total traded quantity was 51122 compared to 2 week average of 101479. The stock hit an intraday high of Rs.82.95 and low of Rs.78.05.

Source : Equity Bulls

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