Tag: Prescription Drugs

The FTC required drug supplier Novartis AG to give up its marketing rights to four topical skin care medications, under a settlement resolving charges that Novartis' acquisition of pharmaceutical firm Fougera Holdings, Inc. would harm competition in the market for these topical drugs. The settlement order requires Novartis to end a marketing agreement that allows it to sell three topically-applied generic drugs and return all rights to a fourth generic drug in development to its manufacturer, Tolmar, Inc. According to the FTC's complaint, Novartis' acquisition of Fougera would violate Section 5 of the FTC Act and Section 7 of the Clayton Act by reducing competition in the generic drug markets for three skin care drugs: 1) generic calcipotriene topical solution, 2) generic lidocaine-prilocaine cream, and 3) generic metronidazole topical gel. The complaint also alleges that the acquisition would eliminate potential competition in the market for the sale of diclofenac sodium gel.

On 10/7/2011, the FTC required Teva Pharmaceutical Industries Ltd. to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant, as a condition of its proposed $6.8 billion acquisition of rival drug firm Cephalon, Inc. In addition, the proposed settlement requires Teva to enter into a supply agreement that will allow a competing firm to sell a generic version of Cephalon’s wakefulness drug Provigil in 2012. On 7/3/2012, the FTC issued its final order. The final amended FTC order resolving the charges requires Teva to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant to Par Pharmaceuticals, Inc. It also requires Teva to enter into a supply agreement that will allow Par to sell a generic version of Cephalon's wakefulness drug Provigil in 2012.

On 7/26/2011, the Commission required generic drug manufacturers Perrigo Company and Paddock Laboratories, Inc. to sell six generic drugs under a proposed settlement resolving charges that Perrigo’s proposed $540 million acquisition of Paddock would be anticompetitive. The proposed settlement also contains provisions to ensure future competition in the market for generic testosterone gel product. On 6/26/2012, the FTC issued a modified final order that required the companies to sell six generic drugs to Watson Pharmaceuticals, Inc.

On 12/12/2011, the FTC approved orders requiring Valeant Pharmaceuticals International, Inc. to divest three drugs used to treat different skin ailments, as conditions of acquiring Ortho Dermatologics, Inc. from Johnson & Johnson, and Dermik Laboratories, Inc. from Sanofi. Under the settlements, Valeant will sell the manufacturing and marketing rights to drug products that treat acne and actinic keratosis, a pre-cancerous skin lesion, to Mylan Pharmaceuticals Inc. Valeant also will sell the marketing rights to a drug that treats fine line wrinkles to Spear Pharmaceuticals, Inc. Both settlements preserve competition and prevent higher prices that likely would have resulted from the acquisitions. (also see 1110216).

On 12/12/2011, the FTC approved orders requiring Valeant Pharmaceuticals International, Inc. to divest three drugs used to treat different skin ailments, as conditions of acquiring Ortho Dermatologics, Inc. from Johnson & Johnson, and Dermik Laboratories, Inc. from Sanofi. Under the settlements, Valeant will sell the manufacturing and marketing rights to drug products that treat acne and actinic keratosis, a pre-cancerous skin lesion, to Mylan Pharmaceuticals Inc. Valeant also will sell the marketing rights to a drug that treats fine line wrinkles to Spear Pharmaceuticals, Inc. Both settlements preserve competition and prevent higher prices that likely would have resulted from the acquisitions. (also see 1110215).

In 2006, Ovation Pharmaceuticals, manufacturer of Indocin, a drug used in the treatment of patent ductus arteriosus, a congenital heart defect usually found in severely underweight premature babies, purchased the rights to the drug NeoProfen, a drug about to receive FDA approval for the treatment of the same condition which effects approximately 30,000 babies per year in the United States.  After its FDA approval, Ovation released its NeoProfen treatment, charging similar prices. According to the Commission’s complaint, Ovation’s acquisition was intended to maintain its monopoly in the market for this treatment, and the Commission sought divestiture of assets related to one of the two treatments, and also disgorgement of all unlawfully obtained profits from the sale of these two treatments. In August 2010, the district court dismissed the complaint, finding that the two drugs were in separate product markets. The Commission, along with the State of Minnesota, has appealed the court’s ruling to the Eighth Circuit. On August 19, 2011 the Eighth Circuit affirmed the district court's decision. FTC and Minnesota filed a petition for rehearing en banc on October 3, 2011, and the petition was denied.  The FTC closed its investigation.

The Commission required Hikma Pharmaceuticals PLC (Hikma) to divest two generic injectable pharmaceuticals – phenytoin and promethazine – as part of a settlement allowing it to acquire certain assets from Baxter Healthcare Corporation, Inc. (Baxter). Hikma proposes to acquire Baxter’s entire generic injectable pharmaceutical business for $111.5 million, including Baxter’s Cherry Hill, New Jersey, manufacturing facility and a warehouse and distribution center in Memphis, Tennessee. Phenytoin is an anti-convulsant drug used to control and prevent seizures during or after surgery and Promethazine is used to prevent some types of allergies or allergic reactions, to prevent or control motion sickness, nausea, vomiting, and dizziness, and to help patients go to sleep and control their pain or anxiety before or after surgery.

To settle FTC charges that its proposed acquisition of Alcon, Inc., would be anticompetitive, Novartis AG agreed to sell an injectable eye care drug used in cataract surgery. Novartis and Alcon are the only two U.S. providers of the class of drugs known as injectable miotics, and the FTC alleges that the acquisition would have created a monopoly in injectable miotics. The settlement requires Novartis to sell its drug Miochol-E to Bausch & Lomb, Inc.

The Commission charged that Watson Pharmaceuticals, Inc.’s acquisition of Robin Hood Holdings Limited, owner of Arrow Pharmaceuticals, would have harmed consumers by eliminating future competition for important generic drugs used to treat Parkinson’s disease (cabergoline) and the side effects of chemotherapy (dronabinol). The Commission’s order requires the firms to sell assets related to the two drugs to FTC-approved buyers and to ensure the acquirers have the means to compete effectively in the future.

There is a related federal proceeding and two related administrative proceedings:

• Watson Pharmaceuticals / Actavis Inc.
• Watson Pharmaceuticals, Inc. and Andrx Corporation