Antitrust Law Daily Wrap Up, ANTITRUST NEWS: Actavis, Forest Laboratories to divest four generics to settle FTC action, (Jul 1, 2014)

By Linda O’Brien, J.D., LL.M.

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 FTC charges that Actavis’s acquisition of Forest likely would be anticompetitive, the FTC announced yesterday.

In its complaint (In re Matter of Actavis plc and Forest Laboratories, Inc., File No. 141-0098), the FTC charged that Actavis’s acquisition of Forest, as originally proposed, would violate federal antitrust laws by reducing competition in the markets for three current generic products: (1) generic diltiazem hydrochloride extended release capsules (AB4) used to treat hypertension and chronic stable angina; (2) generic ursodiol tablets used to treat primary biliary cirrhosis of the liver; and (3) generic propranolol hydrochloride extended release capsules used to treat hypertension.

The FTC’s complaint also alleged that the proposed transaction would delay the introduction of generic competition against Lamictal ODT, the branded lamotrigine orally disintegrating tablets (ODT) used to prevent seizures, manufactured by Forest and marketed by GlaxoSmithKline plc (GSK). Actavis is the only company to have received Food and Drug Administration (FDA) approval for a generic version of Forest/GSK’s Lamictal ODT. Without the proposed remedy, the acquisition is likely to delay or preclude entirely the entry of Actavis’ generic lamotrigine ODT, thus insulating the branded product from any generic competition for a period of time.

Under the proposed order to settle the FTC charges, 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 proposed settlement will preserve competition in the markets for these important drugs and is part of the FTC’s ongoing effort to protect U.S. consumers from higher heath care-related costs. The agreement will be subject to public comment for 30 days, after which the Commission will decide whether to make the proposed consent order final.

Public comments may be submitted until July 30, 2014. Written comments should be submitted to the FTC, Office of the Secretary, Room H-113, 600 Pennsylvania Ave., N.W., Washington, DC 20580. Comments can also be submitted electronically.

The Commission vote to accept the consent agreement containing the proposed consent order for public comment was 5-0.

Companies: Actavis plc; Forest Laboratories, Inc.

News: Antitrust FederalTradeCommissionNews