Pharma Focus Asia

Breckenridge Pharmaceutical, Inc. Signs Multi-Product Agreement with Sam Chun Dang Pharm. Co. Ltd.

Saturday, July 01, 2017

Breckenridge Pharmaceutical, Inc. announced today that it has entered into a multi-product agreement with Sam Chun Dang Pharm. Co. Ltd. (SCD), based in Seoul, Korea, under which Breckenridge and SCD expect to develop and commercialize at least seven ANDAs.  Under the terms of the agreement, SCD will develop, manufacture and supply the products exclusively for Breckenridge for the U.S. market and Breckenridge will market and distribute the products in its label.  This multi-product agreement represents the first foray for both companies having products developed and manufactured in South Korea for the U.S. market.

This agreement contemplates filing ANDAs for at least six ophthalmic products and one otic product, beginning in the first quarter of 2018.  The total addressable IMS market value for this portfolio is $2.4 billion USD.  

This selection of products also contributes to Breckenridge's Paragraph IV portfolio.  Breckenridge currently has twenty-six (26) ANDAs filed and pending with FDA that contain Paragraph IV patent challenges, and intends to continue that trend in the next several years, focusing on niche and first-to-file Paragraph IV opportunities with certain barriers to entry.

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