Recommended changes to the law on generic drug entry

In a effort to speed the entry of generic drugs, a Federal Trade Commission report recommends several changes to the 1984 Hatch-Waxman Act. The changes would limit the ability of pioneer pharmaceutical companies to prevent regulatory approval of generic competitors pending the outcome of patent litigation. They would also require companies to file copies of certain agreements that might affect the timing of generic entry with the antitrust agencies.

Source: "Generic Drug Entry Prior to Patent Expiration: An FTC Study," available at Morgan, Lewis & Bockius LLP e-mail:

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