Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Armodafinil Tablets (CIV) in 50mg, 150mg and 250 mg strengths (Nuvigil®)
BOCA RATON, Fla., Nov. 28, 2016 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has launched its ANDA for Armodafinil tablets (CIV) in 50mg, 150mg and 250mg strengths on November 28, 2016, after having received final approval by FDA. Armodafinil tablets is a generic version of Nuvigil® by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. Breckenridge and Cephalon entered into a confidential settlement which includes a license to market its ANDA effective 180 days after the initial launch of generic versions of Nuvigil®. Breckenridge is launching Armodafinil tablets with its partner Natco Pharma Limited, who is owner of the ANDA.
Breckenridge's Armodafinil tablets are AB-rated to Nuvigil®, a prescription medicine indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). The total brand and generic market for Nuvigil® generated annual sales of $516 million, based on September 2016 IMS Health Sales Data.
Breckenridge's recent litigation involving Armodafinil 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 and powders. www.bpirx.com
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SOURCE Breckenridge Pharmaceutical, Inc.