FTC Requires Drug Marketer Hikma Pharmaceuticals PLC to Divest Rights to Five Generic Injectable Drugs as a Condition of Acquiring Certain Drug Products from Ben Venue Laboratories, Inc.

The Federal Trade Commission will require generic drug marketer Hikma Pharmaceuticals PLC to divest its rights and interests in five generic injectable pharmaceuticals, as part of a settlement resolving charges that Hikma’s $5 million acquisition of the rights to various drug products and related assets from Ben Venue Laboratories, Inc. would likely be anticompetitive.

Under the terms of the proposed settlement, Hikma is required to divest the five generic injectable drug assets to Amphastar Pharmaceuticals, Inc., a California-based specialty pharmaceutical company that sells generic injectable and inhalation products.

According to the complaint, without a remedy, Hikma’s purchase of certain generic injectables from Ben Venue, a U.S. subsidiary of Boehringer Ingelheim Corporation, would likely harm future competition in the U.S. markets for these products:

• Acyclovir sodium injection: an antiviral drug used to treat chicken pox, herpes, and other related infections.

• Diltiazem hydrochloride injection: a calcium channel blocker and antihypertensive used to treat hypertension, angina, and arrhythmias.

• Famotidine injection: a treatment for ulcers and gastroesophageal reflux disease.

• Prochlorperazine edisylate injection: an antipsychotic drug used to treat schizophrenia and nausea.

• Valproate sodium injection: a treatment for epilepsy, seizures, bipolar disorder, anxiety, and migraine headaches.

The complaint also alleges that entry into the market from new competitors would not be  timely, likely, or sufficient in magnitude to deter or counteract the anticompetitive effects of the acquisition. Drug development and FDA approval requirements are sufficiently time consuming that it would take at least two years for a new competitor to enter the market, according to the complaint.

Details about the case are set forth in the analysis to aid public comment for this matter. The Commission vote to issue the complaint and accept the proposed consent order for public comment was 4-0.

The FTC will publish the consent package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through March 22, 2016, after which the Commission will decide whether to make the proposed consent order final. Comments can be filed electronically or in paper form by following the instructions in the “Supplementary Information” section of the Federal Register notice.

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 $16,000 per day.

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