Glossary
The regulatory, commercial and Qope-specific vocabulary used across the product.
Regulatory
ANDA -- Abbreviated New Drug Application. The pathway for a generic small-molecule drug referencing an approved brand.
NDA -- New Drug Application. The pathway for a new small-molecule drug.
BLA -- Biologics License Application. The pathway for a biological product.
BPCIA -- Biologics Price Competition and Innovation Act. Grants a reference biologic 12 years of exclusivity, after which FDA may license a biosimilar.
Orange Book -- FDA's list of approved small-molecule drug products with therapeutic equivalence evaluations, patent listings and exclusivity data.
Purple Book -- The equivalent list for licensed biological products, including biosimilars and interchangeables.
RLD -- Reference Listed Drug. The approved product an ANDA filer references. Its presence means the molecule is ANDA-ready.
RS -- Reference Standard. The product FDA designates for bioequivalence testing.
TE code -- Therapeutic Equivalence code. Codes beginning with A (AA, AB, AN, AO, AP, AT) mean the product is therapeutically equivalent to the reference and can be substituted at the pharmacy. Codes beginning with B mean it cannot.
AB rating -- The most common A-code. Without it, a pharmacist cannot automatically substitute a generic for the brand.
Exclusivity -- FDA-granted marketing protection, separate from patents. New chemical entity, orphan drug, pediatric and first-generic exclusivities all have different terms.
Tentative approval -- FDA has found a generic application acceptable but cannot approve it because patent or exclusivity still blocks entry. Qope calls these staged generics.
506C notice -- A manufacturer's notification to FDA that it is discontinuing or interrupting production. Appears on the shortage list with status TO BE DISCONTINUED. Not a shortage.
Recall classification -- Class I is the most serious (reasonable probability of serious harm or death), Class II is moderate, Class III is unlikely to cause harm.
UNII -- Unique Ingredient Identifier. FDA's identifier for a substance.
NDC -- National Drug Code. Identifies labeler, product and package.
FEI number -- FDA Establishment Identifier, assigned to a registered facility.
Commercial and access
340B -- The federal drug pricing programme requiring manufacturers to offer discounts to covered entities, including FQHCs.
FQHC -- Federally Qualified Health Center. A HRSA-funded safety-net primary care organisation.
-- An organisation meeting FQHC requirements without federal funding.