Breckenridge files Paragraph IV ANDA litigation with Sanofi for generic version of Jevtana

Breckenridge Pharmaceutical, Inc. announced today that it has filed an ANDA with a Paragraph IV certification for cabazitaxel solution; IV (infusion) in 60 mg/1.5 mL (40 mg/mL) strength, a generic version of Jevtana^® by Sanofi. On January 14, 2015, Sanofi filed a Paragraph IV lawsuit against Breckenridge in the United States 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 Limited.

Jevtana® is a prescription drug that is indicated to treat prostate cancer. Jevtana® generated sales of $120.2 million for the twelve-month period ending November 2014, based on industry sales data.

Breckenridge's latest patent challenge regarding cabazitaxel is a continuing part of its larger strategy to focus on injectable products. Breckenridge's current injectable portfolio consists of oncology and general injectable products in liquid, lyophilized and pre-filled syringe forms. Cabazitaxel is Breckenridge's second first-to-file Paragraph IV injectable ANDA submission. As part of its overall strategy, Breckenridge is also expanding its sales force so it can better promote Breckenridge's growing portfolio of injectable products.