Order Protects Competition for Four Current and Future Generic Drugs
Pharmaceutical companies Actavis plc and Forest Laboratories, Inc. have agreed to sell or relinquish their rights to four generic pharmaceuticals that treat hypertension, angina, cirrhosis, and prevent seizures to settle Federal Trade Commission charges that Actavis’s acquisition of Forest likely would be anticompetitive.
According to the FTC’s complaint, Actavis’s acquisition of Forest, as originally proposed, would violate federal antitrust laws by reducing competition in the markets for three current generic products:
generic diltiazem hydrochloride extended release capsules (AB4) used to treat hypertension and chronic stable angina;
generic ursodiol tablets used to treat primary biliary cirrhosis of the liver; and
generic propranolol hydrochloride extended release capsules used to treat hypertension.
In addition, the FTC’s complaint also alleges that the proposed transaction would delay the introduction of generic competition against Lamictal ODT, the branded lamotrigine orally disintegrating tablets used to prevent seizures, manufactured by Forest and marketed by GlaxoSmithKline plc (GSK). Actavis is the only company to have received FDA approval for a generic version of Forest/GSK’s Lamictal ODT. Unremedied, the acquisition is likely to delay or preclude entirely the entry of Actavis’ generic lamotrigine ODT, thereby insulating the branded product from any generic competition for a period of time.
Under the proposed FTC settlement order, the companies have agreed to relinquish their rights to market generic diltiazem hydrochloride (AB4) to Valeant Pharmaceuticals International, Inc.; sell generic ursodiol and generic lamotrigine ODT to Impax Laboratories, Inc.; and sell generic propranolol hydrochloride to Catalent Pharma Solutions, Inc.
Under the terms of the proposed settlement, Actavis and Forest must ensure the viability, marketability, and competitiveness of the drugs that are being divested until they are sold. To ensure that Actavis and Forest comply with the terms of the proposed order, the FTC has appointed an interim monitor until the divestitures have been completed successfully.
The Commission vote to accept the consent agreement containing the proposed consent order for public comment was 5-0. The FTC will publish a description of the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through July 30, 2014, after which the Commission will decide whether to make the proposed consent order final. Interested parties can submit written comments electronically or in paper form by following the instructions in the “Invitation To Comment” part of the “Supplementary Information” section.
NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000.