BOCA RATON, Fla., March 12, 2015 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has filed an ANDA with a Paragraph IV certification for dabigatran etexilate mesylate capsules EQ 75 mg and EQ 150 mg strengths, a generic version of Pradaxa® by Boehringer Ingelheim. On March 5, 2015, Boehringer Ingelheim 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.
Pradaxa® is a prescription drug that is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa® generated sales of $880 million for the twelve-month period ending January 2015, based on industry sales data.
Breckenridge's dabigatran etexilate mesylate product is a continuing part of its larger effort to bring products to market in conjunction with its parent company, Pensa Dose and the Esteve Group.
Breckenridge's latest patent challenge for dabigatran etexilate mesylate capsules highlights its aggressive Paragraph IV strategy. Breckenridge currently has thirty-eight (38) 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 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
Pradaxa® is a trademark of Boehringer Ingelheim or its affiliates.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/breckenridge-pharmaceutical-inc-announces-paragraph-iv-anda-litigation-with-boehringer-ingelheim-for-its-anda-dabigatran-etexilate-mesylate-capsules-pradaxa-300049912.html
SOURCE Breckenridge Pharmaceutical, Inc.
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