Breckenridge Pharmaceutical, Inc. Announces Paragraph IV ANDA Litigation with Cephalon, Inc. for its ANDA Bendamustine HCl Powder for IV (Treanda®)
BOCA RATON, Fla., June 23, 2014 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has filed an ANDA with a Paragraph IV certification for bendamustine hydrochloride powder for IV (infusion), 25 mg/vial and 100 mg/vial, a generic version of Treanda® by Cephalon, Inc. On May 27, 2014, Cephalon, Inc. filed a Paragraph IV lawsuit against Breckenridge and its development and manufacturing partner Natco Pharma Limited in the United States District Court for the District of Delaware. Breckenridge filed its Paragraph IV ANDA on the first-possible submission date and expects to be entitled to 180-day exclusivity.
Treanda® is a prescription drug that is indicated to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma. Treanda® generated sales of $694 million for the twelve-month period ending April 2014, based on industry sales data.
Breckenridge's latest patent challenge regarding bendamustine is a continuing part of its larger aggressive Paragraph IV strategy. Since 2011, Breckenridge has had at least seventeen (17) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche and first-to-file Paragraph IV opportunities with certain barriers to entry.
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. The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide. The company markets over 70 products in a variety of dosage forms including: Tablets, Capsules, Soft Gel Capsules, Liquids, Suspensions, and Powders. www.bpirx.com
Treanda® is a trademark of Cephalon, Inc. or its affiliates.
SOURCE Breckenridge Pharmaceutical, Inc.