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Thursday, October 17, 2019

Teva Pharmaceutical asks FTC to modify order involving merger, generic drug competition

Federal Gov

By Marian Johns | Oct 30, 2018

WASHINGTON, D.C. —  Teva Pharmaceutical Industries LTD., is requesting the U.S. Federal Trade Commission reopen and modify a 2012 order involving a merger between Watson Pharmaceuticals Inc., and Actavis Inc.

The request stems from the 2012 FTC order that was made to prevent the merger from lessening future generic drug competition in the U.S. markets, including the generic version of the abuse-resistant opioid painkiller sold under the brand name Embeda. 

The order required Watson and Actavis to supply Embeda to Pifizer Inc., for four years after Pfizer's relaunch of the drug in 2015 because Pfizer did not have the capability to independently manufacture Embeda at the time, the FTC said. The FTC also required Watson and Actavis to help transfer Embeda's manufacturing technology to Pfizer or a third party, according to the FTC.

In its recent request to the FTC, Teva seeks an extension of the Embeda supply order because Pfizer has not yet completed the drug's technology transfer to a third party, the FTC said. 

According to Teva, without its supply of Embeda, Pfizer will not be able to supply the drug to patients after December. Teva also said in its request that "public interest heavily favors removing or extending" the supply agreement in order to "preserve Pfizer's ability to supply patients with Embeda." the FTC said. 

The FTC will decide on Teva's request after Nov. 23 when the public comment period has expired, according to the commission. 

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