Rivastigmine Transdermal System Approval

[ December 02, 2019 ]

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


Berlin, CT November 27, 2019– 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.