Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Teriflunomide Tablets (generic for Aubagio®). This product was developed in collaboration with PharmaZell GmbH, Germany. Breckenridge received final approval for the 7mg and 14mg strengths. Sanofi Aventis LLC and Breckenridge have entered into a Settlement Agreement that permits Breckenridge to launch its generic teriflunomide product on March 12, 2023. According to industry sales data, Aubagio generated annual sales of approximately $1.9 billion during the twelve months ending July 2021.
About Pharmazell:
The PharmaZell Group supplies the pharmaceutical industry with Active Pharmaceutical Ingredients and natural source materials. The Group operates production facilities in Germany, Italy and India and offers a focused portfolio of small molecule APIs combined with Custom Development and Manufacturing Services for the pharmaceutical industry worldwide.
