Breckenridge Pharma files ANDA for generic of Sanofi's Jevtana

12 February 2015

Privately-held US generic drugmaker Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application with the US Food and drug administration, with a Paragraph IV certification for cabazitaxel solution; IV (infusion), a generic version of French pharma major Sanofi’s (Euronext: SAN) cancer drug Jevtana.

On January 14, 2015, Sanofi filed a Paragraph IV law suit against Breckenridge in the US District Court for the District of New Jersey. Breckenridge filed its Paragraph IV ANDA on the first-possible submission date and expects to be entitled to 180-day exclusivity. The ANDA was developed and will be manufactured by Breckenridge's partner, Natco Pharma.

Jevtana is a prescription drug that is indicated to treat prostate cancer. It generated US sales of $120.2 million for the 12-month period ending November 2014, based on industry sales data, quoted by Breckenridge. Globally, Jevtana sales reached 273 million euros ($310 million) in 2014, Sanofi reported earlier this month.

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