To identify approved drugs that have not reached the market, Kaiser Health News used the FDA’s Orange Book database – as of Jan. 2 – to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.
According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm, which then told us whether each one was active, inactive, or had no list price as of Jan. 17.
If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.
Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past 2 years, we included it in our analysis.
To determine whether a drug was a first generic, KHN used the FDA’s
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