The Federal Trade Commission will require generic drug marketers Amneal Pharmaceuticals LLC and Impax Laboratories Inc. to divest Impax’s rights and assets for 10 products to three other companies, as part of a settlement resolving charges that Amneal’s $1.45 billion acquisition of an equity share in Impax likely would be anticompetitive.
Under the terms of the proposed settlement, ANI Pharmaceuticals, Inc. will acquire seven products. Perrigo Company plc will acquire Impax’s rights to two products that it had partnered with Impax to develop, manufacture, and sell. G&W Laboratories will acquire Impax’s marketing rights to one product that G&W manufactures for Impax.
According to the complaint, without a remedy, the acquisition would likely harm future competition in U.S. markets for these seven generic products:
- aspirin and dipyridamole extended-release capsules, an antiplatelet therapy used to reduce the risk of stroke;
- azelastine nasal spray, a treatment for seasonal allergies;
- diclofenac sodium and misoprostol delayed release tablets, a pain relief treatment that minimizes gastrointestinal side effects;
- erythromycin tablets, an antibiotic;
- fluocinonide-E cream, a topical corticosteroid used to reduce swelling, redness, itching, and allergic reactions;
- methylphenidate hydrochloride extended release tablets, a central nervous system stimulant used to treat attention-deficit disorder and attention-deficit/hyperactivity disorder; and
- olopatadine hydrochloride nasal spray, a treatment for seasonal allergies.
The complaint also alleges that unremedied, the acquisition would likely harm current competition in these three U.S. markets for the following generic products:
- desipramine hydrochloride tablets, a tricyclic antidepressant;
- ezetimibe and simvastatin immediate release tablets, a treatment to improve cholesterol and lower triglycerides; and
- felbamate tablets, used to treat epileptic convulsions.
According to the complaint, 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. Because of the time it takes for drug development and FDA approval, it would be at least two years for a new competitor to enter the market, the complaint states.
Under the terms of the settlement, ANI will acquire the rights and assets for generic aspirin and dipyridamole ER capsules, generic diclofenac sodium and misoprostol delayed release tablets, generic erythromycin tablets, generic methylphenidate hydrochloride extended release tablets, generic desipramine hydrochloride tablets, generic ezetimibe and simvastatin immediate release tablets and generic felbamate tablets.
As explained in the accompanying analysis to aid public comment, “ANI’s track record in developing and bringing to market pipeline products suggests that the divested products will be placed in the hands of a firm with the same ability and incentive to bring the products to market.”
Perrigo will acquire Impax’s rights to generic azelastine nasal spray and generic olopatadine hydrochloride nasal spray; and G&W will acquire Impax’s rights to generic fluocinonide-E cream.
Additional 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 2-0.
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 May 29, 2018, 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 $41,484.
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