OBJECTIVES: Most accounts put the research and development cost of bringing a new drug to market close to $1B USD (Adams and Brantner, 2010; Dimasi, et al., 2003). At this price, manufacturers cannot afford to launch a product that fails to meet market expectations, yet often products do not perform as anticipated. This effort looks at high-profile FDA approvals and evaluates the market performance with particular emphasis on exploring the reasons drugs do not meet the predicted revenue targets in the first year of sales.  METHODS:  We examined the 2010 and 2011 drug approvals to select the most appropriate NME to examine.  Using data from EvaluatePharma®, we compared the forecasted annual sales estimate just prior to launch with the actual annual sales in the first year on the market.  For the products that failed to meet expectations we examined the news reports from online journals, websites, and reputable news outlets to determine the most likely reason for drug failure. RESULTS: Of 31 products included in the analysis 16 failed to meet the expectations announced in the month prior to launch.  We attributed price or reimbursement as the reason that seven of the 16 products failed to meet market expectations.  Competition due to existing product dominance, near-simultaneous launches for the same patient population, and widely available generics explained the failure of five products. Efficacy questions and label restrictions contributed to the slow uptake of three products. Capacity can be faulted on another product. CONCLUSIONS: As the landscape changes, manufacturers must consider product differentiation and market assessment early to anticipate the market’s price threshold to avoid a key pitfall in new product launches.