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Breckenridge Announces Final Approval of its ANDA for Rivastigmine Transdermal System (generic for Exelon® Patch)

December 2, 2019 GMT

BERLIN, Conn., Dec. 2, 2019 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Rivastigmine Transdermal System in 4.6mg/24 hours, 9.5mg/24 hours and 13.3mg/24 hours strengths (generic for Exelon® Patch by Novartis). Breckenridge’s Rivastigmine Transdermal System was developed in collaboration with Welding GMBH & Co. KG and SK Chemicals Co., Ltd. Exelon® Patch and its therapeutic equivalents generated annual sales of $161 million during the twelve months ending September 30, 2019, according to industry sales data. Breckenridge plans to launch the product immediately.

About Breckenridge:
Breckenridge Pharmaceutical, Inc. is a privately held own-label distributor that performs pharmaceutical marketing, 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, and dosage forms; including: tablets, capsules, liquids, suspensions, ophthalmics, nasal sprays, powders, transdermal patches and injectable products The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. www.bpirx.com.

About Welding:
Welding is a privately owned company, headquartered in Hamburg, Germany, with a subsidiary in Lyon, France. Founded in 1955, Welding tackles the challenges of the global pharmaceutical market with fully compliant and comprehensive finished dosage form (FDF) development solutions for the industry by providing a diversified product portfolio, including but not limited to formulation development, IP, registration, regulatory affairs, licensing, launch and supply chain management. In addition, Welding understands the important role and responsibility that we have as a premier partner in global sourcing, marketing and distribution, as well as regulatory affairs and quality management services for active pharmaceutical ingredients. www.welding.eu

About SK Chemicals:
Since its formation in 1969, SK Chemicals has grown into one of the major healthcare and chemical companies in Korea via a continuous series of innovations. Now, the company is trying to leap forward by reorganizing its corporate structure into Green Chemicals and Life Science, under the mandate, ‘Improve human health and project the global environment.’ When it comes to the Life Science Business, SK Chemicals is deploying a portfolio of diverse products in a push for value-oriented development activities. Its accumulated key competency through consistent R&D investment to expand into the global marketplaces enables SK Chemicals to succeed in a series of out-licensing deals and achievements in a patentable PPI oral tablet, the reformulated generics in transdermal patches, Orally Dissolving Film (ODF), oral controlled-release formulation and human recombinant factor followed by the marketing authorizations of a few products in Europe and the U.S. www.skchemicals.com.

Exelon® is a registered trademark of Novartis AG.

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SOURCE Breckenridge Pharmaceutical, Inc.