Prohibits (for subsequently issued patents) an extension of the 30 month stay of Food and Drug Administration (FDA) approval for any new drug where an abbreviated new drug application (ANDA) contains a Paragraph IV filing/certification and the patent holder indicates an intention to bring a patent infringement suit against the new (generic) drug's manufacturer.
Requires the first generic applicant (ANDA) with a Paragraph IV filing to forfeit the 180 day marketing exclusivity period to a subsequent generic applicant if the first generic applicant engages in certain behaviors which delay or prevent the marketing of the generic drug, including failure to market and agreements with the patent holder which violate the antitrust laws.
Continues current regulations concerning bioeqiovalence.
States that drugs which no longer require a prescription (over-the-counter) but that are sold as if they did are deemed misbranded (mislabeled and subject to seizure).