Patent Cliff

Open Patent Cliff -- in the sidebar under Drugs.

A patent expiry is only an opportunity if somebody can act on it. Patent Cliff starts from the FDA Orange Book, works out when each brand's protection actually lapses this year and next, and then scores what the market looks like on the far side.

Header

• The read -- how much Medicare Part D revenue sits in the markets that open to generics by December of next year, how many of them have no generic maker at all, and which quarter is the heaviest. It shows the refresh date of the oldest input the page uses.
• The KPI strip -- Markets opening by December of next year, Part D $ in those markets (2024 data), how many of them have no generic maker, and Supply-gap openings. Hover any number for how it is counted.

Market open date

Every brand has two clocks:

• Patent -- when the listed patents expire.
• Exclusivity -- when the FDA-granted exclusivity gates expire.

They are different dates and often years apart. A drug can be patent-free but still blocked by exclusivity, and vice versa. The market open date is the latest of all gates, resolved across every Orange Book listing of the brand, and that is the date a generic can actually launch. The whole page works from that final gate. The wave chart on the Cliff tab still has a Patent / Exclusivity toggle to show either clock on its own.

Contestability tiers

Every row carries one of four chips, with the number of generic makers actively marketing the ingredient (not merely holding an approval) shown next to the label:

Hover the chip for the full breakdown: makers actively marketing, makers whose every listing is discontinued (counted separately, not counted as competition), live ANDA listings, whether a Reference Listed Drug is on file, and whether any generic carries an AB therapeutic-equivalence rating. That last one matters: without an AB rating a pharmacist cannot substitute automatically, so brand share erodes far more slowly than the generic count implies.

Signals

Each row shows its tier chip and its single strongest signal. Click the row for all of them:

• In shortage -- the molecule is in an active FDA drug shortage.
• n staged -- staged generics: generic applications (ANDAs) that passed FDA review and wait only on patent or exclusivity, positioned to launch the day protection lapses. They are counted only while the molecule's protection is still running and only until the application is listed in the Orange Book as approved. Brand (NDA) applications are never counted. The same rules apply on Drug Profile.
• Authorized generic -- the brand owner already sells its own authorized generic, so a new entrant faces two-player pricing from day one.
• n selling -- labelers that list a marketed generic NDC for the molecule in the FDA NDC Directory: what is on shelves, not what is approved.
• n approved, 0 selling -- generic makers hold an approval, but nobody lists a marketed generic NDC.
• No AB substitute -- generics exist but none are automatically substitutable.

The expanded row also shows the final gate (patent or FDA exclusivity), the last patent and last exclusivity dates with their exclusivity codes, the brand's NADAC price per unit next to the generic of the same presentation, links to the Orange Book listings and the drug profile, and the brand's top Part D prescribers by NPI, state and specialty.

At generic price

What the brand's Medicare Part D spend (2024 data) would be worth at generic prices once you enter, shown as a range:

At generic price = Part D spend x (1 - generic discount)

The discount comes from the What generics sell for panel on the Opportunities tab. For every molecule on the page that already has a priced generic, it compares the brand's latest NADAC with the generic CMS pairs to the same presentation, and groups molecules by the number of labelers listing a marketed generic NDC: 1 to 3, 4 to 9 and 10 or more sellers. A row uses the group it would fall into with you added as one more seller, and the range is the middle half (25th to 75th percentile) of that group. A group needs at least 5 molecules, and brands priced under $1 a unit are left out because cent rounding would distort the discount.

It is a range, not a forecast. It assumes today's volume moves to generic, ignores rebates, and the value is shared by every generic seller, not yours alone.

Tabs

Cliff

The default view and the screening list.

• Markets opening -- one row per molecule and brand owner whose market opens between today and the end of next year, grouped by quarter. Each row shows the open date and months left, the reference brand, the brand owner, the generic field (tier plus strongest signal), Part D spend and At generic price. Brand owners spelled two ways in the Orange Book (for example "Merck Sharp and Dohme LLC" and "Merck Sharp and Dohme Corp, a sub of Merck") are merged into one row. Molecules where every brand is discontinued are left out. Export downloads every opening as CSV, including later years and discontinued brands.
• Watch -- the radar icon next to each brand adds the molecule to Radar, which alerts you when a generic is approved or staged, the protection date moves, or the molecule goes into shortage.
• Patent cliff wave (or Exclusivity cliff wave) -- brands losing protection each year, against the Part D revenue at risk (2024 data). Bars for brands still protected by another gate are shaded separately. Click a year to open the Orange Book.
• Applicants facing the steepest cliffs -- companies ranked by Part D revenue on brands whose final gate falls in the window (or by brand count when no spend matched). Subsidiaries are grouped to the parent name. Click a company to open its Orange Book rows.

Opportunities

Three views:

• Ranked -- Scored opportunities, the top ten entry candidates whose market opens by the end of next year, with Exposure, Whitespace and Urgency each shown as a 0-100 meter, At generic price and the combined score. A molecule with no matched Part D spend gets no score and ranks below every scored row rather than being given a zero. Below it, What generics sell for plots each priced molecule's generic discount by number of sellers.
• Supply gaps -- molecules losing protection that are also in an active FDA shortage right now. A supply gap the market cannot currently fill, about to become legally contestable, is the strongest combined signal in the product. Rows whose every gate has already lapsed read Open now -- contestable today -- and are listed first; they carry no staged count, since nothing is left to wait for. Exports as CSV.
• Biologics -- reference biologics whose 12-year BPCIA exclusivity, counted from first licensure, ends between today and the end of the year three years from now -- the earliest date FDA can license a biosimilar. This is not a market-open date: the Purple Book carries no patent data, and patents almost always run past it. It shows the reference biologics in range, their Part D spend (2024 data, a floor because most bill under Part B) and how many already have licensed biosimilars.

The opportunity score (0-100):

Score = min(100, round(100 x whitespace x exposure x urgency x shortage))

Targets

Two views:

Prescribers to switch -- Medicare Part D prescribers (2024 data) writing brands whose final patent or exclusivity gate falls between today and the end of next year. These are the accounts where a generic conversation lands soonest.

• Filter by state, specialty and brand owner, and turn on Winnable only to keep prescribers writing a Greenfield or Open drug -- the brands actually worth launching against.
• Sort by Opportunity, Urgency, Spend, Claims or Brands.
• Each row shows the prescriber, specialty, expiring brands, Part D spend on those brands, winnable spend, the soonest market-open date and the index. Spend and claims count only the expiring brands, not the prescriber's whole book.
• Add any prescriber to a lead list, or Export the list as CSV.

The opportunity index (1-100) ranks prescribers against the top prescriber under the current filters:

Index = max(1, round(100 x raw score / top raw score)), where the raw score sums, over the prescriber's expiring brands, Part D drug cost x whitespace x proximity x discontinued.

Brand owners at risk -- the brand-side view. Each brand losing protection by the end of next year is split by posture:

• Naked -- the patent is the last gate, so generics can enter the day it lapses.
• Cushioned -- FDA exclusivity runs past the patent. A stay, not a save.

It totals the Part D revenue on naked cliffs and the revenue cushioned by exclusivity, then ranks applicants by revenue sitting on naked cliffs, with each applicant's brands, final gate and remaining exclusivity codes. Posture is resolved across every Orange Book listing of the brand. Export downloads the portfolios as CSV. Useful if you are on the originator side rather than the entrant side.

Opened this year

Molecules whose last Orange Book patent and exclusivity gate lapsed earlier this year, then checked against the FDA NDC Directory to see what actually reached the market. It counts the molecules that have a generic on shelves, the ones open with nobody selling, and the median entry lag from gate to first generic NDC. Rows flag Open, no entrant and AG only, no rival (only the brand owner's authorized generic). A gate lapsing and a generic shipping are not the same event, and this tab is where the difference shows.

Known limitations

• One row per molecule and brand owner. The Orange Book lists one row per application, strength and patent, so a single brand appears many times. Patent Cliff resolves them to one market-open date per molecule and brand owner; the Orange Book table still shows every row.
• Medicare figures are a floor. Every brand losing protection in the window is looked up in Medicare Part D and its top prescriber lines are summed, so prescribers below that cutoff are not counted. Brands with no Part D match show "--", not zero, and get no score. Physician-administered (Part B) drugs are out of scope. See Data Caveats.
• Medicare figures are 2024 data, the latest year CMS has released. Every panel names its inputs in its header, and the Sources line at the foot of the page gives each input's refresh date.