Legal Library: Cases and Proceedings

Pharmaceutical companies Impax Laboratories Inc. and CorePharma, LLC agreed to divest all of CorePharma’s rights and assets to generic pilocarpine tablets and generic ursodiol tablets, in order to settle FTC charges that Impax’s proposed $700 million acquisition of CorePharma would likely be anticompetitive. Without the divestitures required by the proposed order, the FTC alleges that the acquisition would reduce the number of future suppliers in the markets for generic pilocarpine tablets, which are used to treat dry mouth, and generic ursodiol tablets, which are used to treat biliary cirrhosis, a chronic disease of the liver, as well as gall bladder diseases. CorePharma’s entry as an independent competitor would likely have resulted in significantly lower prices for each of these drugs. According to the FTC’s complaint, there are currently only two suppliers in the market for generic pilocarpine tablets, and Impax and CorePharma are the only likely new entrants into this market in the near future. In the market for generic ursodiol tablets, there are currently four suppliers, including Impax. This market
has recently experienced supply shortages, which can diminish competition among suppliers. CorePharma is one of a limited number of firms likely to enter the generic ursodiol market in the near future.

Pharmaceutical companies Sun Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. agreed to divest Ranbaxy’s interests in generic minocycline tablets in order to settle FTC charges that Sun’s $4 billion proposed acquisition of Ranbaxy would likely be anticompetitive. Torrent Pharmaceuticals Ltd., a global drug company based in India that markets generic drugs in the United States, will acquire the divested assets. Under the settlement, Sun and Ranbaxy must also sell Ranbaxy’s generic minocycline capsule assets to Torrent, to enable Torrent to achieve regulatory approval for a change in ingredient suppliers for its minocycline tablets as quickly as Ranbaxy would have been able to do in the absence of the deal. In addition, Sun and Ranbaxy must supply generic minocycline tablets and capsules to Torrent until the company establishes its own manufacturing infrastructure.

An association representing electricians agreed to eliminate provisions in its bylaws that the FTC charged limit competition among each association’s members. The FTC alleged that the purpose and effect of the association's bylaws has been to restrain competition by discouraging and restricting competition among PLASMA members. The consent order settling the FTC’s charges requires PLASMA to revise its bylaws, publicize its settlement with the FTC, and implement an antitrust compliance program.

Akorn, Inc. has agreed to sell its rights to develop, manufacture, and market the generic injectable tuberculosis drug, rifampin, in order to settle FTC charges that Akorn’s proposed acquisition of VersaPharm Inc. and its parent company, VPI Holdings Corp., would likely be anticompetitive. According to the FTC’s complaint, only VersaPharm and two other firms currently have FDA approval to sell generic injectable rifampin and there are no viable substitutes for rifampin as a course of treatment for tuberculosis. The FTC’s proposed settlement with Akorn requires the company to divest its Abbreviated New Drug Application for generic injectable rifampin – which is currently pending before the Food and Drug Administration – to Watson Laboratories, Inc.

Pharmaceutical companies Actavis plc and Forest Laboratories, Inc. 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. 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. In addition, the FTC’s complaint also alleges that the proposed transaction would delay the introduction of another generic drug. 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.

Valeant Pharmaceuticals International, Inc. and Precision Dermatology, Inc. agreed to sell or relinquish rights to Precision’s branded single-agent topical tretinoins and generic Retin-A, common acne treatments, to settle FTC charges that Valeant’s proposed $475 million acquisition of Precision would likely be anticompetitive. According to the FTC complaint, Valeant’s proposed acquisition of Precision would likely reduce competition in the market for branded and generic single-agent topical tretinoins, and in a separate market for generic Retin-A. The proposed consent order requires Valeant to sell Precision’s assets related to Tretin-X, its branded single-agent topical tretinoin, to Actavis, Inc., and Precision’s assets related to generic Retin-A to Matawan Pharmaceuticals LLC, a subsidiary of Rouses Point Pharmaceuticals.

Akorn Enterprises, Inc. and Hi-Tech Pharmacal, Inc. agreed to sell the rights and assets to three generic prescription eye medications and two generic topical anesthetics to Watson Laboratories, Inc., to settle FTC charges that Akorn’s proposed $640 million acquisition of Hi-Tech would be anticompetitive and lead to higher prices for consumers. The proposed order requires the parties to sell either Akorn’s or Hi-Tech’s rights and assets to each of the five drug products to Watson, and requires Akorn to assign Watson its contract for making branded and generic EMLA cream within 10 days after the deal is consummated. In addition, the companies must maintain the drugs to be sold as viable, marketable, and competitive pending their divestiture, and must allow the FTC to appoint a monitor to ensure that the companies comply with the order’s requirements.