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Natco Pharma Ltd has on Monday said that its marketing partner in the US, Breckenridge Pharmaceutical, Inc, has filed an Abbreviated New Drug Application (ANDA) for Bendamustine Hydrochloride powder.
The filing, if approved, could provide the company, 180 days of exclusivity on the drug as Natco and Breckenridge believed that they were ‘first-to-file’, according to a release.
$660 m market size Teva (Cephalon) sells Bendamustine Hydrochloride under brandname Treanda, which is used as a chemotherapy medicine in oncology segment.
The market size of Bendamustine Hydrochloride in the US is approximately $660 million for 12 months ending September 2013, according to IMS Health, the Hyderabad-based company said.
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