Glossary

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.

Staged generic -- A generic (ANDA) that passed FDA review but is not on the market yet, waiting only on patent or exclusivity protection. Qope shows its date as "passed FDA review" and the date, and counts it only while protection still blocks it and it is not yet listed.

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.

Look-alike -- An organisation meeting FQHC requirements without federal funding.

HPSA -- Health Professional Shortage Area. A HRSA designation for primary care, dental or mental health shortage, carrying a score from 0 to 26 where higher means greater shortage.

MUA and MUP -- Medically Underserved Area and Medically Underserved Population, scored by the Index of Medical Underservice (IMU). Lower IMU means more underserved.

ACO -- Accountable Care Organization. A provider group taking accountability for cost and quality for a population of Medicare beneficiaries.

MSSP -- Medicare Shared Savings Program, the largest ACO programme.

NADAC -- National Average Drug Acquisition Cost. What pharmacies actually pay to acquire a drug.

MDRP -- Medicaid Drug Rebate Program. Its drug list carries termination dates that reveal supply exits early.

Part B -- Medicare medical benefit. Covers physician-administered drugs. Part B drugs do not appear in Part D prescribing data.

Part D -- Medicare outpatient prescription drug benefit.

LIS -- Low Income Subsidy under Part D.

PI criteria -- Promoting Interoperability criteria, the successor to Meaningful Use. Hospitals attest to meeting them using certified health IT.

CHPL -- Certified Health IT Product List, maintained by ONC.

NPI -- National Provider Identifier. The 10-digit identifier for a US healthcare provider.

NPPES -- The registry that issues and publishes NPIs.

HCPCS -- The procedure coding system used for Medicare billing.

Qope terms

Drugs and markets

Contestability tier -- How open a molecule's market is to a new generic entrant, by the number of generic makers actively marketing it: Greenfield (none), Open (1 to 3), Crowded (4 to 9) or Eroded (10 or more). Shown as a coloured chip on Patent Cliff, Drug Profile and Radar. Makers whose every listing is discontinued do not count.

Dormant market -- A small-molecule drug with no marketed generic, no protection still running, and a first approval at least 10 years ago. Looks like greenfield but usually is not.

Market open -- The soonest date a generic can actually launch: the latest of every patent and exclusivity gate for the ingredient plus originator.

Runway -- Time remaining until market open.

Supplier tier -- Single source, Thin supply, Moderate or Deep supply. How many distinct Orange Book applicants still market an approved product for a molecule in shortage, by the same route as the short product. Listings flagged discontinued do not count.

Structural shortage -- A shortage on a single-source or thin-supply molecule, so at most three manufacturers still market the product. There is little or no backup, and the shortage reads as a supply-base failure rather than a demand spike.

Quiet market exit -- A labeler terminating NDCs in the Medicaid rebate programme for a drug that is not on the FDA shortage list. Frequently precedes a declared shortage.

Providers

KOL tier -- Tier 1 (Dream KOL), Tier 2 (Specialist) or Tier 3 (Watch list): a ranking of a provider's Medicare volume within a peer group. See Methodology.

Brand-heavy -- A provider whose brand share of Part D drug cost is at p90 or above in its peer group.

Radar

Watch -- An item on your Radar: a drug, a maker, a market, a county, or a view (the row count of a filtered table). Regular allows 3 watches of each kind, Pro and Teams 25.

Radar list -- A named group of watches, for example one per client. Picking a list filters the whole Radar page to it. See Radar Lists and Sharing.

Client link -- A read-only web link to one Radar list that works without a Qope login. Pro and Teams. Stop link turns it off and the old link stops working.

Monday brief -- A weekly email of one Radar list's changes and upcoming protection end dates, switched on per list with Email me this brief on Mondays. Pro and Teams.

Instant radar alert -- One of the five time-sensitive changes on a watched drug that is emailed once two consecutive twice-daily checks confirm it: first generic or biosimilar competition, an active FDA shortage, a Class I recall, protection expiring, or a cliff date moving by more than 90 days. Pro and Teams.

Incomplete data -- A watch whose sources did not all answer. Radar marks it and records no change from it, so a failed read never looks like a change.

Workspace and teams

Lead list -- A working pipeline of records with statuses, notes and follow-ups.

Pin -- A bookmark on one record, kept on your account.

Saved view -- A table's filters and sort saved under a name on your account.

Seat -- A teammate's place on a Teams plan. 5 are included and a team can have up to 15. See Teams and Members.

Territory -- The states the team owner assigns to a member on the Hub. Territory Brief opens on your first assigned state.

Team intel -- The panel on a record page where teammates claim a record, leave notes and see who has worked it. Teams only.

Claim -- Owning a record in Team intel so nobody else on the team works it twice. Release hands it back.

Partial load -- An analysis page notice that one of its sources failed or answered only in part. The page says which, and does not show the missing figures as zero.