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Back To News: Bendamustine HCl Powder for IV (Treanda®) Approval Granted
Bendamustine HCl Powder for IV (Treanda®) Approval Granted
[Jan 06, 2017]

Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval

for Bendamustine HCl Powder for IV (Treanda®)


Boca Raton, Florida, January 6, 2017 - Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA bendamustine hydrochloride powder for IV (infusion), 25 mg/vial and 100 mg/vial, a generic version of Treanda® by Cephalon, Inc. Breckenridge, and its development and manufacturing partner Natco Pharma Limited, filed the ANDA with Paragraph IV certification on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers. Pursuant to settlement of the Paragraph IV litigation, Breckenridge intends to launch the ANDA on November 1, 2019, or earlier based on certain circumstances.


Treanda® is a prescription drug that is indicated to treat chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.  Treanda® powder for IV (infusion) generated sales of $133 million for the twelve-month period ending November, 2016 based on industry sales data.


Breckenridge’s recent litigation involving Bendamustine highlights its aggressive Paragraph IV strategy.  Breckenridge currently has thirty (30) ANDAs filed and pending with FDA that contain 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. 


About Breckenridge:

Breckenridge Pharmaceutical, Inc. is a privately-held own label Distributor that performs pharmaceutical research and development as well as marketing and distribution in the U.S. The company was founded in 1983 and 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, ophthalmics, nasal sprays, powders and injectables.

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