The federal government both grants and restricts marketing advantages. For example, the patent protection and market exclusivity the government affords some pharmaceutical compounds lays the groundwork for a new drug to become a blockbuster brand. On the other hand, FDA approval of a generic can presage the demise of a brand drug. Pharmaceutical companies and consumers alike depend upon the government getting it right in both granting and eliminating market exclusivity. The story of Wellbutrin XL illustrates this point.
Wellbutrin Becomes a Blockbuster Drug
Welllbutrin Yields the Market to Generic Competition
Patients Report Treatment Failures
The testing and treatment failures were brought to the attention of FDA. The agency cited the relatively small numbers of reported adverse events and the fact that the nature of the disease state lends itself to intermittent return, as reasons to uphold its original assessment of therapeutic equivalence.
FDA Withdraws Its Approval of Impax’s Generic Wellbutrin
Further Fallout
This article was prepared by Bob Rouder (rrouder@fulbright.com / 512 536 2491) and Saul Perloff (sperloff@fulbright.com / 210 270 7166) of Fulbright’s False Advertising Practice.