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Pharmaceutical companies Pfizer Inc. and Mylan N.V. have agreed to divest assets and abide by other conditions to settle Federal Trade Commission charges that the proposed combination of Upjohn Inc. and Mylan N.V. will harm current or future competition in ten generic drug markets. Under the proposed deal, Pfizer Inc. will spin off its Upjohn division—which includes Pfizer’s authorized generic business Greenstone, LLC—and combine it with Mylan. The new entity will be called Viatris. Pfizer will receive $12 billion from Viatris as partial consideration for the Upjohn spin-off. The FTC’s complaint alleges that the proposed combination would harm current U.S. competition in seven product markets by reducing the number of existing suppliers of: (1) amlodipine besylate/atorvastatin calcium tablets, which combine a calcium channel blocker to treat hypertension with a lipid-lowering agent to treat high cholesterol; (2) eplerenone tablets, a diuretic prescribed in combination with other medications when treating hypertension or congestive heart failure after a heart attack; (3) phenytoin chewable tablets, which are used to prevent epileptic seizures; (4) prazosin HCl capsules, an alpha-adrenergic blocker that treats hypertension by relaxing the veins and arteries so that blood can more easily pass; (5) spironolactone HCTZ tablets, a diuretic used to treat hypertension; (6) gatifloxacin ophthalmic solution, an eye drop that treats bacterial conjunctivitis; and (7) medroxyprogesterone acetate injectable solution, an injectable solution used to treat certain types of dysfunctional uterine bleeding. In three additional product markets, according to the complaint, the proposed combination would delay or eliminate a likely entrant, reducing the likelihood that prices would decrease in the future for: (1) levothyroxine sodium tablets, which treat hypothyroidism or are used in combination with other drugs to treat thyroid cancer; (2) sucralfate tablets, which are used to treat and prevent ulcers in the small intestines; and (3) varenicline tartrate tablets, which are a smoking cessation aid offered under Pfizer’s Chantix® brand. The proposed settlement seeks to remedy competitive concerns in these ten generic pharmaceutical markets by requiring the parties to divest to Prasco, LLC the rights and assets related to Upjohn’s amlodipine besylate/atorvastatin calcium tablets, phenytoin chewable tablets, prazosin HCl capsules, spironolactone HCTZ tablets, gatifloxacin ophthalmic solution, and medroxyprogesterone acetate injectable solution. The parties must also divest the rights and assets related to Mylan’s eplerenone tablets. The proposed order also requires prior Commission approval before Upjohn, Mylan, or Viatris may gain an interest in or exercise control over any third party’s rights to levothyroxine sodium tablets, sucralfate tablets, and varenicline tartrate tablets. As explained in the accompanying analysis to aid public comment, the generic drugs divested to Prasco will continue to be manufactured by Upjohn and Mylan’s current suppliers, reducing the risk of any interruption in supply. In some instances, Pfizer—which will remain a separate entity from Viatris—will serve as Prasco’s contract manufacturer, allowing Prasco to step into the shoes of Upjohn/Greenstone. Commission staff and the staff of antitrust agencies in Australia, Canada, the European Union, and New Zealand worked cooperatively to analyze the proposed transaction and potential remedies. The Commission vote to issue the complaint and accept the proposed consent order for public comment was 3-2. Commissioners Rohit Chopra and Rebecca Kelly Slaughter voted no. Commissioner Christine S. Wilson issued a statement. Commissioner Chopra issued a dissenting statement, which was joined by Commissioner Slaughter. The FTC will publish the consent package, along with instructions for filing comments, in the Federal Register shortly. After a 30-day public comment period, the Commission will decide whether to make the proposed consent order final. 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 $43,280.
Jasmine Y. Rosner
Bureau of Competition