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Breckenridge Pharmaceutical Inc.

BOCA RATON, Fla. -- Breckenridge Pharmaceutical Inc. is a privately held pharmaceutical company that was founded in 1983.

The company is headquartered in Boca Raton, Fla. and markets a broad range of generic prescription products in many therapeutic categories. The company introduced several Abbreviated New Drug Applications (ANDAs) recently, including estradiol/norethindrone acetate tablets (0.5 mg/0.1 mg). The product is a "first to market" genetic version of Activella 0.5/0.1 mg.

Breckenridge also introduced methylphenidate solution, the generic version of Methylin, which was filed with a Paragraph IV certification under the Hatch-Waxman Act. The product had a 180-day generic exclusivity period, which was granted under the first-to-file statute. Breckenridge also launched anastrozole (Arimidex), bicalutamide (Casodex), granisetron (Kytril), hydrocortisone enema (Cortenema), letrozole (Femara), neomycin tablets and terbinafine (Lamisil) in the last year and recently received approval for levetiracetam tablets, which it plans to launch soon.

Breckenridge markets additional ANDA products, including estradiol/norethindrone acetate tablets 1 mg/0.5 mg (generic version of Activella); oxcarbazepine tablets (generic version of Trileptal); meloxicam tablets (generic version of Mobic); Ascomp w/ codeine (generic version of Fiorinal with codeine); butalbital, acetaminophen, caffeine and codeine phosphate (generic version of Fioricet with codeine); cyclobenzaprine (generic version of Flexeril); methylprednisolone (generic version of Medrol); polyethylene glycol powder (generic version of Miralax); folic acid tablets; and Vitamin D capsules (generic of Drisdol).

The company plans to introduce several more products before year-end.

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 all contain Sumalate pursuant to an exclusive license and supply agreement with Albion Laboratories. Sumalate was previously used in the TherRx brand products: Niferex, Chromagen, Precare and Repliva. The company also has an exclusive license agreement with Pamlab to market its Folbee, Folbic and Folbee Plus products.

The company is part of the worldwide organization Esteve SA.

"Breckenridge continues to focus its efforts on product development to ensure that we provide our customers with a steady stream of new items for years to come. We are working on over 50 ANDAs, many of which are currently filed and pending FDA approval, and we have many more projects in various stages of development," says Larry Lapila, executive vice president.

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

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

1141 S. Rogers Circle, Suite 3

Boca Raton, Fla. 33487

Key contacts:

MARTY SCHATZ,

Senior Vice President of Sales

LARRY LAPILA,

Executive Vice President

Phone: (561) 443-3314

Fax: (561) 989-9747

www.bpirx.com

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Title Annotation:RX/Generic Drugs/Profiles
Publication:Chain Drug Review
Article Type:Company overview
Geographic Code:1U5FL
Date:Sep 26, 2011
Words:459
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