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Breckenridge Pharmaceutical.

BOCA RATON, Fla. -- Breckenridge Pharmaceutical Inc. is an own-label generic pharmaceutical company that was founded in 1983 and is headquartered in Boca Raton, Fla.

Breckenridge is the U.S. subsidiary of PENSA, the generic arm of Esteve SA.

In 2013 Breckenridge launched several Abbreviated New Drug Applications (ANDAs), including: carbinoxamine maleate tablets and liquid, cilostazol tablets (Pletal), lansoprazole capsules (Prevacid), pioglitazone capsules (Actos), propranolol LA capsules (Inderal LA) and rizatriptan IR and ODT tablets (Maxalt & Maxalt MLT). The company has plans to launch several more products in the immediate future.

On September 11, Breckenridge expanded its current product portfolio and R&D pipeline by acquiring 18 Cypress Pharmaceutical ANDAs from Pernix Therapeutics. The acquisition included seven products formerly marketed by Cypress as well as several that are filed with the Food and Drug Administration and/or in development.

"These assets are a natural fit and complement the Breckenridge portfolio," says executive vice president Larry Lapila.

In June, the company announced that it filed a Paragraph IV for the ANDA of Megace ES by Strativa Pharmaceuticals, a division of Par Pharmaceutical Inc. and Alkermes Pharma Ireland Ltd. This patent challenge is a continuing part of the company's larger aggressive Paragraph IV strategy commenced a few years ago.

Since the beginning of 2011, Breckenridge has filed 12 Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.

Breckenridge partners with contract developers and manufacturers throughout the world and continues to focus its efforts on product development to ensure that it provides its customers with a steady stream of new items. The company is working on over 60 ANDAs, many of which are currently filed and pending FDA approval, with many more projects in various stages of development.

Breckenridge is offered numerous product and marketing opportunities and is collaborating with over a dozen companies. This will position the company for significant growth in the coming years.

The company is the exclusive authorized-generic distributor for all Metafolin-containing brand products developed and distributed by Pamlab Inc., a Nestle Health Science subsidiary. All Breckenridge authorized generics are subject to exclusive patent licenses and sublicenses. Breckenridge's authorized generics are pharmaceutically identical to their Pamlab brand counterparts and are the only generic products to contain Metafolin (a registered trademark of Merck KGaA, Darmstadt, Germany).

Breckenridge also markets the only authorized versions of patented Sumalate iron-containing products: Ferrex 28, Ferrex 150 Plus, Ferrex 150 Forte Plus, Multigen, Multigen Plus and Multigen Folic through an exclusive license and supply agreement with Albion Laboratories. Sumalate was previously used in the TherRx brand products: Niferex, Chromagen, Precare and Repliva.

Breckenridge markets about 70 products in a variety of dosage forms and therapeutic categories.

1141 S. Rogers Circle, Suite 3

Boca Raton, Fla. 33487

Key contacts:

LARRY LAPILA

Executive Vice President

MARTY SCHATZ

Senior Vice President of Sales

Phone: (561) 443-3314

Fax: (561) 989-0819

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Title Annotation:RX/Generic Drugs/Profiles
Publication:Chain Drug Review
Article Type:Company overview
Geographic Code:1U5FL
Date:Sep 30, 2013
Words:489
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