BOCA RATON, Fla., May 3, 2016 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that Breckenridge and MSN Laboratories Private Limited were granted final approval for their ANDA lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg. a generic version of Vimpat® by UCB Pharma. Breckenridge and MSN filed their Paragraph IV ANDA on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers. Litigation is pending with a trial court decision expected shortly. Further announcements will be made prior to product launch.
VIMPAT® (lacosamide) (C-V) is a prescription medicine that can be used alone or with other medicines to treat partial-onset seizures in people 17 years of age and older. Vimpat® generated sales of $782 million, based on February 2016 IMS Health Sales Data. The product will be available in 50mg, 100mg, 150mg and 200mg tablets.
Breckenridge's latest patent challenge for lacosamide tablets 50mg, 100mg, 150mg and 200mg highlights its aggressive Paragraph IV strategy. Breckenridge currently has twenty-five (25) 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.
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 and powders. www.bpirx.com
About MSN Laboratories:
Headquartered in Hyderabad, INDIA, MSN Laboratories Private Limited is one of the fastest growing research - based pharmaceutical companies developing and manufacturing high-quality generic formulations and APIs.
With around 200+ US API DMFs, 15 filed US ANDA's and a pipeline of 30+ ANDAs, the group markets 120+ generic prescription products across various therapeutic segments and dosage forms in over 35 countries worldwide.
The MSN group has 450+ patents and patent applications across the world. www.msnlabs.com
Vimpat® is a trademark of UCB Pharma. or its affiliates.
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SOURCE Breckenridge Pharmaceutical, Inc.