Prescription Drugs Introduced to Market

This dataset provides data for new prescription drugs introduced to market in California with a Wholesale Acquisition Cost (WAC) that exceeds the Medicare Part D specialty drug cost threshold. Prescription drug manufacturers submit information to HCAI within a specified time period after a drug is introduced to market. Key data elements include the National Drug Code (NDC) administered by the FDA, a narrative description of marketing and pricing plans, and WAC, among other information. Manufacturers may withhold information that is not in the public domain. Note that prescription drug manufacturers are able to submit new drug reports for a prior quarter at any time. Therefore, the data set may include additional new drug report(s) from previous quarter(s).

There are two types of New Drug data sets: Monthly and Annual. The Monthly data sets include the data in completed reports submitted by manufacturers for calendar year 2024, as of May 3, 2024. The Annual data sets include data in completed reports submitted by manufacturers for the specified year. The data sets may include reports that do not meet the specified minimum thresholds for reporting.

The program regulations are available here: https://hcai.ca.gov/wp-content/uploads/2024/03/CTRx-Regulations-Text.pdf

The data format and file specifications are available here: https://hcai.ca.gov/wp-content/uploads/2024/03/Format-and-File-Specifications-version-2.0-ada.pdf

DATA NOTES: Due to recent changes in Excel capabilities, it is not recommended that you save these files to .csv format. If you do, when importing back into Excel the leading zeros in the NDC number column will be dropped. If you need to save it into a different format other than .xlsx it must be .txt