OBJECTIVES: Reimbursement of brand drugs is typically set as a percentage of manufacturers’ listed prices. Thestudy evaluates trends the manufacturer listed prices at market entry of oral solid forms of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in the period 1990-2012. METHODS: Drug regulatory information derived from the FDA. Daily defined dosages (DDD) were collected from the World Health Organization. Average wholesaler prices (AWP) per unit at market entry derived from the RedBook. Prices were converted to 2013 dollars using the consumer price index. Descriptive statistics, 95% confidence intervals and t-tests were performed in the analysis. RESULTS: The FDA approved 576 NMEs during the study period; 505 were marketed as of Dec 31, 2013, and 339 had a solid oral form at approval. The analysis included 243 NMES withcomplete DDD and price information. There were 141 NMEs approved in the 1990s, 82 in the 2000s and 20 in the period 2000-2013. The average AWP per DDD was $13.81±$31.99 (95%CI:$8.53-$19.09) in the 1990s, $45.54±$92.44 (95%CI:$25.53-$65.55) in the 2000s, and $112.83±$175.27 (95%CI:$36.02-$189.64) in the period 2010-2013. The average AWP per DDD was significantly higher (p=0.001) for FDA priority review drugs ($59.01±$113.90, 95%CI:$34.80-$83.23, n=85) than for standard review drugs ($18.50±$52.38, 95%CI:$10.33 $26.66). It was also higher (p=0.005) for orphan drugs ($88.64± $112.85, 95%CI: $43.49-$133.79, n=24) than for non-orphan drugs ($26.54± $75.27, 95%CI: $16.57-$36.50). Last, the AWP was significantly higher (p<0.001) for drugs marketed as of December 2013 ($34.75±$84.66, 95%CI: $23.66-$45.84, n=224) than for discontinued drugs ($8.15±$5.30, 95%CI: $5.76-$10.53, n=19). CONCLUSIONS: Manufacturer listed prices for oral formulations of NMEs at market entry are increasing over time. Orphan and priority review drugs have significant higher prices at market entry than other drugs.