By Maria Armental


Pfizer Inc. and Mylan NV have reached a deal with U.S. regulators over the spinoff of Pfizer's off-patent drugs business that requires the sale of several generic drugs to Prasco LLC as well as Mylan's eplerenone tablets to address competition concerns.

Under the terms of an agreement with the Federal Trade Commission, which clears the way for the deal to close next month creating what would be the largest generic pharmaceutical firm in the world, the generic drugs divested to Prasco would continue to be manufactured by Upjohn and Mylan's current suppliers, reducing the risk of any interruption in supply, the FTC said.

In some cases, Pfizer would serve as Prasco's contract manufacturer, "allowing Prasco to step into the shoes of Upjohn/Greenstone," the FTC said. Greenstone LLC is Pfizer's authorized generic business.

Aside from Mylan's eplerenone, the generic drugs covered by the agreement are 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 proposed order also requires FTC approval before Upjohn, Mylan, or Viatris Inc.--the company that would be created from the merger of Upjohn off-patent drugs business with Mylan--can gain an "interest in or exercise control over any third party's rights" to levothyroxine sodium tablets, sucralfate tablets, and varenicline tartrate tablets.

Commissioners Rohit Chopra and Rebecca Kelly Slaughter voted against the proposed deal, saying that both companies had been accused of collusion in the generic drug business and that Rajiv Malik, who would be Viatris president, is a defendant accused of antitrust misconduct.


Write to Maria Armental at


(END) Dow Jones Newswires

October 30, 2020 14:08 ET (18:08 GMT)

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