Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched amifostine for injection 500mg on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). This product has been added to Caraco's Paragraph IV marketing agreement with Sun Pharma that was signed on January 29, 2008. Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Ethyol(R), and being the first-to-file an ANDA with a Paragraph IV certification, has a 180-day marketing exclusivity. Sun Pharma is currently involved in patent litigation with MedImmune Oncology, Inc. concerning this product in the U.S. District Court for the District of Maryland.
Amifostine is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with ovarian cancer. This new product is bioequivalent to Ethyol(R), a registered trademark of MedImmune Oncology, Inc. Ethyol(R) had U.S. sales of approximately $80 million for the 12-month period ended December 31, 2007, according to IMS Data.
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