GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION: AN FTC STUDY.
Item #: 5171
Published: Buffalo; William S. Hein & Co., Inc./Bflo; 2003.
Series: HEIN'S ELECTRONIC DOCUMENTS REPRINT SERIES
Subjects: BUSINESS/ECONOMICS, FOOD, DRUGS & COSMETICS, INTELLECTUAL & INDUSTRIAL PROPERTY
This study examined whether the conduct that the FTCchallenged, which was certain antitrust actions againstbrand-name and generic drug companies, represented isolatedinstances or is more typical, and whether the 180-dayexclusivity and the 30-month stay provisions of the Hatch-Waxman Amendments are susceptible to strategies to delayor deter consumer access to generic alternatives to brand-name drug products. The study focuses solely on theprocedures used to facilitate generic drug market entryprior to expiration of the patent(s) that protect brand-name drug product.
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