Teva Pharmaceutical Industries Ltd. and Cephalon, Inc. announced that the US Federal Trade Commission (FTC) has accepted the proposed consent order in connection with the pending acquisition of Cephalon by Teva and granted early termination of the Hart Scott Rodino waiting period.
Under the consent order that has been executed by the parties and accepted for public comment by the FTC, Teva is required to divest two Abbreviated New Drug Applications (ANDAs) for fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix. According to IMS Health data, annual sales in the US for Actiq and the equivalent generic products are $173 million. Annual brand sales in the US for Amrix are approximately $125 million. Teva will also grant non-exclusive US rights to an undisclosed company to market modafinil tablets, the generic version of Provigil, which had annual brand sales in the US of approximately $1.1 billion.
The parties expect to close the transaction by October 14, 2011 subject to approval by the European Commission.
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.