Drug Profile

Open Drug Profile -- in the sidebar under Drugs.

Drug Profile takes one drug name and assembles what the public FDA and CMS registries know about it into one page.

Public summary pages for selected drugs are published at www.qope.org/drugs. Each one has an Open full profile button that opens this page for the same drug.

Searching

Type a brand or ingredient name into the search box. Suggestions appear as you type, each tagged Brand, Molecule or Biologic.

• Lookup uses exact FDA Orange Book and Purple Book names. Type the full brand (Lipitor, Humira) or the full ingredient (atorvastatin calcium).
• A brand and its ingredient reach the same molecule-level data: competition, supply, demand, pricing and safety. The header and product record follow what you typed. Search Lipitor and they describe Lipitor; search atorvastatin calcium and they describe the earliest-approved brand of that ingredient.
• Searching a biosimilar's proper name (for example adalimumab-adaz) shows that biosimilar's own product, maker and CMS price, not the reference brand's.
• If nothing matches, the page says so and offers up to five suggested names under Did you mean.

The landing page

With no drug searched, the page shows the search box, a Compare two drugs button, a Recent searches menu, and six boards under Where the market is moving today:

• Generics waiting at the gate -- staged generics ready to launch.
• Patent cliffs ahead -- brands losing patent protection this year and next.
• In shortage right now -- drugs FDA lists as in active shortage.
• Biosimilar battlegrounds -- reference biologics facing the most biosimilar competition.
• Biggest brand-to-generic gaps -- brands still priced far above their generic, per unit.
• Priciest drugs to acquire -- the highest NADAC acquisition costs among tracked specialty brands.

Each board links to the full view or table behind it. It is a starting point, not a saved view.

Header

The header card carries:

• The name and identity line -- the originator (or application holder), approval date, other brands, route and form, and strengths.
• Status pills -- the protection state (Generics on market, LOE with a date, Exclusivity with a date for biologics, or Protection lapsed), the contestability tier, Generics staged when staged generics are waiting and none is marketed yet, the shortage state, and a safety pill when the signal is Elevated or Serious. If a source did not load, the pill says the data is incomplete instead of showing a clean result.
• The read -- one or two sentences on where the drug stands, with a countdown of protection left when protection is still running, or the number of competing makers when generics or biosimilars are already on the market.
• The KPI strip -- Generic makers (Biosimilar makers for biologics), Staged generics, OB listings (Purple Book rows for biologics), Brands, First approval, and NADAC per unit.

The NADAC figure is a representative CMS acquisition price for the drug's own presentations: the middle price at the latest survey date (the lower of the two middle prices when the count is even), in the dosage form and unit with the most priced presentations. A named biosimilar with no CMS price of its own shows no price rather than borrowing the reference brand's.

Approvals that the Orange Book records as before January 1, 1982 show as before 1982, never as 1982.

Actions

Next to the search box:

• Compare -- opens a second search box. Pick another drug to see the two side by side, field by field: modality, originator, first approval, contestability, makers, protection runway, substitutability, discontinued products, active shortage and safety signal.
• Share -- copies the page link (or opens your device's share sheet).
• Copy brief -- copies a plain-text summary of the profile with a link back to the page.
• Watch -- adds the molecule to your Radar.
• Export -- downloads the profile as a formatted Excel workbook, one tab per section. Tick the sections you want or use a preset (Everything, Executive brief, Commercial, Regulatory). Export needs an active subscription and counts against your plan's monthly export allowance. See Usage and Limits.

On your first visit, a short tour points out Watch, Export, Compare and the tabs.

Tabs

Overview, The Verdict, Timeline, Supply and Safety always appear. The other tabs appear only when the underlying data exists for that molecule -- a drug with no Medicare Part B billing has no Part B tab.

Overview

• Product record -- generic name, originator or application holder, route and form, strengths, application number, first approval, loss of exclusivity, and listing count.
• Marketed products -- from the FDA NDC Directory: marketed NDCs, dosage forms, routes, marketing category, top labelers, and whether the drug is a controlled substance. The NDC count covers every marketed NDC of the molecule, including listings filed without the salt name when they belong to one of the drug's own Orange Book applications; other salts of the same molecule stay out. Bulk-ingredient and further-processing NDCs are counted separately as supply-only.
• Generic competition (Biosimilar competition for biologics) -- the contestability meter: Greenfield, Open, Crowded or Eroded, with generic makers on the market, ANDA filings and brand filings. A Substitutability box says whether any generic is A-rated, so a pharmacist can substitute it without prescriber sign-off. When no ANDA generic is approved yet but CMS already prices a generic version, the card names it -- usually an authorized generic sold under the brand's own application.
• Protection runway -- time left on patents and exclusivity, with the exclusivity codes on file (hover a code for its meaning).
• Acquisition cost -- a preview of the NADAC pricing.
• Modality -- whether the drug is in the Purple Book, and for biologics the biosimilar licensures against the reference product.

The Verdict

One scored read of the drug's market position, for three seats. Pick a seat to see its answer.

Each seat starts from a neutral Starting score and each signal on the page adds or subtracts points, shown line by line under What drives the score. The result is a score from 0 to 100 with a rating, a headline and a Recommended move. For the generic maker and procurement seats, 68 or more is the top rating and 44 to 67 the middle one; for the investor seat the cut-offs are 64 and 40.

When new chemical entity exclusivity is still running, the generic maker's recommended move names the date it stops barring an ANDA filing with a patent challenge, rather than telling you to file now. The scoring is a ranking device, not a forecast -- read the factors, not just the number.

Timeline

The Lifecycle timeline: approval, protection, competition, safety, supply and regulatory events in one chronology, with a marker for today and projected patent and exclusivity expiries after it. Events include first FDA approval and its holder, first generic approved, last patent expiry, exclusivity end, the date generics can enter, the first week a generic price appeared in NADAC, staged generics, recalls, active shortage listings and the most recent FDA filing. For biologics, Purple Book dates are shown as licensures (Reference licensed, Biosimilar licensed), not launches. Year-only dates are marked with a tilde.

Makers

Who makes it ranks the applicants holding approvals for this ingredient by Orange Book (or Purple Book) listings, each tagged brand, generic, reference, biosimilar or exited. For small-molecule drugs, the radar icon next to a maker watches that company on Radar. Below it are All active generic makers and Combination products -- fixed-dose combinations containing the molecule. Combinations are separate markets and are not counted in this profile's competition and supply figures.

The Players

The company-level view: makers in market, how concentrated the market is in the top maker, generic filers, and who has left the market. Each player shows its footprint against its peers and its generic share of portfolio. Applicant names that resolve to the same company are counted once.

Regulatory

The Regulatory radar, from Drugs@FDA:

• Generic launch radar -- staged generics for this molecule and how many makers hold them, with each application, sponsor, drug name and the date it passed FDA review. Staged applications for fixed-dose combinations are listed separately and excluded from the count.
• Originator activity -- original approval, supplements filed and last FDA activity, with a status of actively maintained or dormant (no filings in over three years).
• What to watch -- the next events likely to move the market.

A staged generic is a generic application (ANDA) that has passed FDA review but cannot launch yet because a patent or exclusivity still blocks it. Qope counts it only while that protection is still running and only until the application appears in the Orange Book as approved. Brand (NDA) applications are never counted. For a combination drug, a staged application must contain every component.

Supply

• Supply resilience -- the share of products discontinued, active products, active makers and exited makers, rated Broad supply, Stable, Thinning or Fragile, with a one-line read.
• Supply status -- any FDA shortage record for the drug, with its stated reason.
• Medicaid rebate footprint -- how the drug shows up in the Medicaid Drug Rebate Program: NDCs in the program, active and exited labelers, single-source share, the drug category mix, and a Line extension on file chip where one applies. The Generics in market badge appears only while at least one generic NDC is still active in the program.

Demand

Medicare Part D demand (2024 data): Part D drug cost, claims, beneficiaries and prescribers, then the top prescribers by Part D drug cost and breakdowns by state and specialty that link to the Providers table. Demand is matched on the molecule (brand and generic combined) or on the brand only, and the panel says which.

The figures are a floor built from the highest-spend Part D prescriber lines, not the whole program. CMS suppresses beneficiary counts under 11. Physician-administered (Part B) use is on the Part B tab.

Part B

Medicare Part B buy-and-bill -- what Medicare pays clinicians to buy and administer the drug in the office or clinic, across the HCPCS codes that carry it:

• Medicare paid, Billing units, Allowed per unit (the closest proxy to ASP + 6%) and Billing sites.
• Where the Medicare money moves -- the split between Part B and Part D spend, when both exist.
• Matched HCPCS codes -- Medicare paid, units, allowed per unit, charge markup and NPIs per code.
• Top billing sites by Medicare paid (each opens the provider page), plus breakdowns by state and specialty.

Hospital outpatient billing, Medicare Advantage and commercial payers are out of scope, and CMS suppresses lines under 11 beneficiaries, so every figure is a floor.

Pricing

• Generic switch opportunity -- for a brand that still has Part D scripts and a cheaper generic: the acquisition cost recoverable by switching the remaining brand scripts to the generic. It prices the 2024 Part D day supply at the 2024 average brand-versus-generic NADAC gap of the brand's own presentations, assuming one unit per day, so the brand cost lines up with what Part D actually paid that year.
• Acquisition cost (NADAC) -- cheapest and priciest presentation, number of presentations priced, and a chart of price per unit over time with any FDA shortage window shaded.
• Per-presentation acquisition cost -- each presentation with its last survey date, unit, NADAC per unit, the corresponding generic per unit and the gap. Click a presentation to open its full weekly price history.

How prices are matched:

• The latest prices come from the newest survey date in the NADAC file.
• Prices for a sibling salt are excluded, so fluticasone furoate is never priced with fluticasone propionate products.
• Combination products are kept out of a single drug's price, and a combination drug is never priced with a product that adds another active ingredient.

NADAC is what retail pharmacies pay to acquire the drug -- not the list price, and not what a patient pays.

Erosion

The Price erosion atlas -- what happened to the generic and brand price after comparable brands lost exclusivity, measured from NADAC history and anchored to the first week a generic carried a price. It shows the generic price as a share of the pre-loss-of-exclusivity brand price at generic entry and at milestones after it, as headline figures, a curve, the cohort spread at each milestone (from 3 to 60 months) and the longest-observed comparables. Where the drug has lost exclusivity itself, its own measured curve is set against its peers. For a drug with no generic yet, it projects prices from the cohort median. NADAC covers retail acquisition cost only, and a projection is a median of past behavior, not a forecast for this drug.

Safety

The Safety signal: FDA adverse-event reports (FAERS) and recalls for the molecule, rated Clean, Watch, Elevated or Serious, with reports matched, serious-outcome share, deaths reported, recent recalls, and a table of recall events with class, reason, firm and date.

Most FDA recall records carry no structured drug name, so Qope also searches the recall text for the molecule across the most recent records. The recall count is therefore a floor; when the search window is cut off it reads "at least" that number.

Listings

Orange Book listings for the ingredient, with brand or generic type, applicant, strength, form and route, therapeutic-equivalence code and patent date. DISCN marks a discontinued presentation. For the complete set, use All Orange Book rows in the Drill in row at the foot of the page, which also links to the Patent Cliff calendar, the Shortages tracker, NADAC price history, Part D prescribers and Part B drug billing where they apply.

Caveats worth knowing

• Combination products. Staged generics, prices and recalls must match every component of a combination drug, and products that add another active ingredient are left out. Where a lookup cannot match every component, Qope shows nothing rather than a single component's number.
• Biologics follow a different regime: 12-year BPCIA reference-product exclusivity, tracked in the Purple Book, and biosimilars instead of ANDA generics. The originator shown is the holder of the first-licensed reference product. Where FDA has not published an exclusivity expiry, the date is estimated from first approval and labeled as estimated.
• A dormant market -- no generic marketed, no patent or exclusivity still running, first approval ten or more years ago -- is labeled Dormant, separately from a genuine Greenfield opening.
• Failed lookups are not zeros. When a source does not load, the affected panel says so. Reload before reading it as a clean result.