Tag: Prescription Drugs

The Commission charged Biovail Corporation with illegally acquiring an exclusive patent license for Tiazac, a pharmaceutical used to treat high blood pressure and chronic chest pain. The complaint further alleged that Biovail, in an effort to maintain its monopoly, wrongfully listed the acquired license in the U.S. Food and Drug Administration’s “Orange Book” for the purpose of blocking generic competition to its branded Tiazac. The consent order requires Biovail to divest part of its exclusive rights to DOV; prohibits the firm from taking any action that would trigger additional statutory stays on final FDA approval of a generic form of Tiazac; and also prohibits Biovail from wrongfully listing any patents in the Orange Book for a product for which the company already has an New Drug Application from the FDA.

Roche agreed to divest, certain assets in the U.S. and Canada to settle antitrust concerns stemming from its proposed acquisition of Corange Limited. The consent order permits the acquisition but requires the divestiture of Cardiac thrombolytic agents (drugs used to treat heart attack victims) and ongoing business assets relating to chemicals used to test for the presence of illegal or abused drugs.

The Commission negotiated an agreement with The Hearst Corporation (Hearst) to settle a permanent injunction action filed by the FTC alleging that Hearst failed to provide documents required by premerger notification law and then consummated a merger that monopolized the integrated drug information database market. Under the terms of the order, Hearst divested the Medi-Span business to Lippincott Williams & Wilkins, Inc. , a subsidiary of Wolters Kluwer, n.v., disgorged $19 million in profits, and to complied with certain other obligations.

A consent order settled allegations in an administrative complaint that charged that Hoechst agreed to pay Andrx Corporation millions of dollars not to market and distribute a generic version of Hoechst’s branded Cardizem CD, a once-a-day diltiazem drug product used in the treatment of hypertension and angina. The consent order prohibits the companies from entering into agreements designed to restrict the entry of generic competitors in an attempt to monopolize relevant markets .

Under terms of a final consent order settling charges stemming from the merger of SmithKline and Glaxo Wellcome plc, the parties agreed to divest pharmaceutical products in six markets: antiemetics; the antibiotic, ceftazidime; oral and intravenous antiviral drugs for the treatment of herpes; topical antiviral drugs for the treatment of genital herpes; and over-the-counter H-2 blocker acid relief products.

Complaint filed in the U.S. District Court for the District of Columbia charged Mylan with restraint of trade, monopolization and conspiracy to monopolize the market for two generic drugs used to treat anxiety, lorazepam and clorazepate, through exclusive dealing arrangements.  The Commission alleged that Mylan, Gyma Laboratories of America, Inc., Cambrex Corporation and Profarmaco S.R.L. conspired to deny Mylan’s competitors ingredients necessary to manufacture lorazepam and 40 clorazepate. The complaint sought consumer redress of at least $120 million and to enjoin the alleged illegal exclusive licensing agreements. The district court upheld the Commission’s authority to seek restitution in antitrust injunction actions under Section 13(b).  The Commission approved a $100 million settlement. The opinion settled Commission concerns that Mylan, Gyma Laboratories of America, Inc., Cambrex Corporation and Profarmaco S.R.L. conspired to deny Mylan’s competitors ingredients necessary to manufacture lorazepam and 40 clorazepate. On Feburary 1, 2002, the court granted approval to a plan of distribution to injured consumers who paid the increased prices and state agencies, including Medicaid programs, that purchased the drugs while the illegal agreements were in effect. The funds were distributed by the states.

Final consent order permits Pfizer’s merger with Warner-Lambert Company and requires divestitures in several pharmaceutical markets including: Pfizer’s RID brand of head lice treatment; Pfizer’s antidepressant drug, Celexa; Warner’s Cognex, a drug used in the treatment of Alzheimer’s disease; and assets relating to the Epidermal Growth Factor receptor tryosine kinase inhibitor - drugs under development to treat solid cancerous tumors such as head and neck, non-small cell lung, breast, ovarian, pancreas and colorectal cancers.

Abbott and Geneva Pharmaceuticals settled charges that the two firms entered into an illegal agreement to stop the marketing and development of a competing generic drug. According to the complaint, Abbott, manufacturer of Hytrin – the brand name for terazosin HCL, a prescription drug used to treat hypertension and benign prostatic hyperplasia, entered into an agreement with Geneva Pharmaceuticals whereby Abbott would pay Geneva millions of dollars not to market a generic version of Hytrin. The orders bars Abbott and Geneva, among other things, from entering into agreements in which a generic company agrees with a manufacturer of a branded drug to delay or stop the production of a competing drug.

Consent order, resolving antitrust concerns relating to Zeneca's merger with Astra AB requires the divestiture of all assets relating to levobupivacaine, a long-acting local anesthetic. The assets were sold to Chiroscience Group plc, the developer of levobupivacaine.

The complaint, issued with the consent order, alleged that as a result of Merck's 1993 acquisition of Medco, the nation's largest benefits manager, Merck's drugs received favorable treatment through Medco's drug-list formulary made available to medical professionals who prescribe and dispense prescriptions to health plan beneficiaries. The consent order requires Medco, among other things, to maintain an "open formulary" to include drugs approved by an independent Pharmacy and Therapeutics Committee, staffed by physicians and pharmacologists who have no financial interest in Merck.

The Commission authorized staff to file separate motions in federal district court to block the mergers of the nation's four largest drug wholesalers into two wholesale distributors of pharmaceutical products. The Commission charged that Cardinal 's proposed acquisition of Bergen Brunswig Corporation and McKesson Corporation's proposed acquisition of AmeriSource Health Corp. would substantially reduce competition in the market for prescription drug wholesaling and lead to higher prices and a reduction in services to the companies' customers --hospitals, nursing homes and drugstores --and eventually to consumers. Two separate motions for preliminary injunctions were filed in the U.S. District Court for the District of Columbia March 6, 1998. On July 31, 1998, the District Court granted the Commission's motions enjoining both proposed mergers. The parties abandoned their respective merger plans soon after the decision.

Consent order settles charges that the proposed acquisition of Solvay, S.A.'s animal health business would reduce competition in the market for the research, development, manufacture and sale of canine lyme vaccine, canine corona virus vaccine, and feline leukemia vaccine. The order requires divestiture of Solvay's U.S. and Canadian rights to the three types of vaccines to the Schering-Plough Corporation or another Commission-approved buyer.

Final consent order settles antitrust concerns in three markets affected by the proposed acquisition of Sandoz Ltd.: research and development in gene therapy products that are being targeted for life-threatening conditions such as hemophilia and cancer; corn herbicides; and flea control products. In the gene therapy market, the order requires the licensing of certain intellectual properties to Rhone-Poulenc Rorer and other firms to permit continued competition in research, development and commercialization for a broad range future medical treatments. In addition, in one of the largest divestitures eve1 required under a consent order, Sandoz agreed to divest its U.S. and Canadian corn herbicide business to BASF Aktiengesellschaft within 10 days. The consent order also requires the divestiture of Sandoz's flea control business to Central Garden and Pet Supply of Lafayette, California within 30 days.

Order settles charges that the acquisition of National Medical Care, Inc. would combine two significant producers of HD concentrate used in hemodialysis treatment. The order requires the divestiture of the Lewisberry, Pennsylvania hemodialysis concentrate plant to Di-Chem, Inc. or other Commission-approved buyer.