Breckenridge Pharmaceutical, Inc. 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.

Breckenridge Pharmaceutical, Inc. is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products in many therapeutic categories.