Anavex Life Sciences Corp (AVXL)

[sokol]

The FDA has a procedure for approving generic substitutes. Among other things, bio-equivalence must be proven. See also the Hatch-Waxman Act, briefly described as follows:

Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA). Section 505(j)(2)(A)(vii)(IV), often referred to as Paragraph IV, gives the first company to file an ANDA for a particular drug 180 days of exclusive rights to market the drug as the generic alternative to the branded drug. The 180 days begins on the first day of marketing the drug under the ANDA, if the paragraph IV certification is not challenged by the pioneer manufacturer. If the paragraph IV certification is challenged by the pioneer manufacturer, the 180 days begins on the date a court finds that,as required under paragraph IV, the patent of the pioneer manufacturer was not valid, enforceable, or not infringed.

The Act enables a generic pharmaceutical manufacturer to develop copy of a patented innovator drug without duplicating the clinical and non-clinical studies or risking liability for patent infringement damages. The generic manufacturer must only demonstrate bioequivalence to the innovator.