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news.US-based Breckenridge Pharmaceutical has filed an abbreviated new drug application (ANDA) with a Paragraph IV certification for dabigatran etexilate mesylate capsules EQ 75mg and EQ 150mg strengths, which is a generic version of Boehringer Ingelheim's Pradaxa.
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In March 2015, Boehringer filed a Paragraph IV lawsuit against Breckenridge in the US District Court for the District of New Jersey, in return 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 indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Based on industry sales data, Pradaxa generated sales of about $880m for the twelve-month period ending January 2015.
According to Breckenridge, its dabigatran etexilate mesylate product is a continuing part of its effort to bring products to market in conjunction with its parent company, Pensa Dose and the Esteve Group.
Currently, Breckenridge has 38 ANDAs filed and pending with FDA that contain Paragraph IV patent challenges.
The company 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.