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Breckenridge Pharmaceutical.

BOCA RATON, Fla. -- Breckenridge Pharmaceutical Inc., founded in 1983, is a privately held generic own label distributor that performs pharmaceutical research and development as well as marketing and distribution in the United States.

With gross sales in excess of $500 million, the company markets a broad range of generic prescription products in many therapeutic categories. Breckenridge is the U.S. subsidiary of Pensa, the generic arm of Esteve SA, which is headquartered in Barcelona.

The company has a strong pipeline with over 80 ANDAs (Abbreviated New Drug Applications) in development, approximately half of which are currently filed and pending Food and Drug Administration approval. This will ensure that its customers have a steady stream of new products available for years to come, according to the company.

Breckenridge also has an aggressive Paragraph IV strategy and has 26 ANDAs that are filed and pending with the FDA that contain Paragraph IV patent challenges, and the company intends to continue that trend in the next several years, focusing on complex dosage forms, niche products and first-to-file Paragraph IV opportunities with certain barriers to entry.

Breckenridge markets more than 70 products in a variety of dosage forms including tablets, capsules, soft-gel capsules, liquids, suspensions, ophthalmics, nasal sprays and powders. Its pipeline also includes injectable, transdermal and topical products.

Last year, Breckenridge received approval for Azelastine HC1 Nasal Solution (Nasal Spray), a generic version of Astelin, marketed by Meda Pharmaceuticals. Breckenridge also received FDA approval for Repaglinide Tablets, 5 mg, 1 mg and 2 mg strengths. Repaglinide Tablets are AB-rated to Prandin.

The company also received approval for Dutasteride Soft Gelatin Capsules 0.5 mg, which are AB-rated to Avodart as well as approval for its ANDA Desvenlafaxine Succinate Extended-Release Tablets, 50 mg and 100 mg (Pristiq by Pfizer Inc.).

Last year, the company filed a first-to-file Paragraph IV for Dabigatran (Pradaxa) and Cabazitaxel Solution (Jevtana).

The Breckenridge label is recognized by retail pharmacy chains, mail order pharmacies, pharmacy benefit managers, managed care facilities and group purchasing organizations as well as wholesalers and distributors throughout the United States.

6111 Broken Sound Pkwy.

N.W., Suite 170

Boca Raton, Fla. 33487

Key contacts: MARTY SCHATZ

Senior Vice President, Sales and Marketing


Vice President, Business Development

Phone: (860) 828-8140

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Title Annotation:Generic Drugs Report: Company Profiles
Publication:Chain Drug Review
Date:Sep 26, 2016
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