Actavis sells rights to drugs to settle antitrust concerns

Actavis has agreed to sell the rights to three generic oral contraceptives and one other drug to resolve the government's antitrust concerns with the drugmaker's $8.5 billion acquisition of Warner Chilcott.

The Federal Trade Commission filed a complaint (PDF) Friday alleging that the merger of drug companies would reduce competition for the four generic drugs. The commissioners voted 4-0 at the same time to accept a proposed resolution to settle the allegations and allow the merger to proceed.

As part of the deal, Parsippany, N.J.-based Actavis would sell all intellectual property and production rights to the four drugs to Amneal Pharmaceuticals, a Bridgewater, N.J., company that has 65 other generic drugs on the market.

The four drugs affected by the proposed order are:

• generic Femcon FE, a branded oral contraceptive produced by Warner Chilcott. Actavis is the only drugmaker that sells significant volumes of a generic version of the drug;

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• Loestrin 24 FE and Lo Loestrin FE, for which no company currently manufactures generic equivalents. In both cases, Actavis is among a small number of companies capable of producing generic equivalents;

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• and Atelvia, a branded postmenopausal osteoperosis drug sold by Warner Chilcott. Actavis may be the first company to enter the market with a generic equivalent in the near future.

Officials with Actavis and Warner Chilcott were not immediately available for comment. The settlement will be subject to public comment for 30 days before final approval.

Federal officials have made access to contraceptives and competition among generic drug-makers high priority topics in recent years.

HHS announced in February that approved contraceptives would be among the essential health benefits that are required to be covered by most insurance plans without cost-sharing for preventive healthcare. That means contraceptives approved by the Food and Drug Administration cannot be subject to copayments, and women in most plans will not have to pay anything out of pocket for them once they have met their annual deductibles.

Also, the FTC has aggressively battled Actavis in court over the company's decision not to sell a generic version of testosterone-replacement therapy AndroGel. FTC lawyers say Actavis was close to winning a lawsuit that would have given it the legal right to sell a generic version when it agreed to accept payments from AndroGel's maker, Abbott Laboratories subsidiary Solvay Pharmaceuticals, that required it to delay the drug launch.

The pharmaceutical companies said the FTC had no right to challenge their decision to settle drug-patent litigation, but in June the Supreme Court disagreed and said the agency does have jurisdiction in “pay for delay” cases. The agency is now litigating the merits of its case in district court.

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