Sources & Methods

DRUG INFORMATION

Where a single active ingredient is marketed under multiple brand names or formulations, each product is listed separately to reflect distinct pricing and Medicare spending histories. This applies to the sitagliptin products (Januvia, Janumet, Janumet XR) and daratumumab products (Darzalex, Darzalex Faspro). Where multiple formulations share the same brand name, Medicare spending and beneficiary data were combined into a single entry. This applies to Dupixent (pen and syringe) and Skyrizi (On-Body, pen, and subcutaneous injection).

Drug (Brand Name)

The proprietary trade name under which the drug is marketed in the United States.

Drug (Nonproprietary Name)

The generic or international nonproprietary name (INN) of the drug’s active ingredient(s).

Company

The principal company marketing the branded version of the drug in the U.S., along with any significant partners that may also receive income from sales in the U.S.

Primary Condition Treated

The main disease category for which each drug is used, based on all U.S. Food and Drug Administration (FDA) approved clinical indications through 2025.

Drug Type

Small molecule is a category of medicines consisting of organic chemical compounds, typically pills that are swallowed. Biologic is a category of medicines such as therapeutic proteins and monoclonal antibodies derived from living cells, typically drugs that are injected into the body.

Delivery Method

The route of administration by which the drug is delivered to the patient. Categories include oral (taken by mouth), oral inhaler, intravenous (IV) infusion, and subcutaneous injection. Source: FDA-approved prescribing information.

PATENTS

Company

The principal company marketing the branded version of the drug in the U.S., along with any significant partners that may also receive income from sales in the U.S.

Primary Condition Treated

The main disease categories for which each drug is used, based U.S. Food and Drug Administration (FDA) approved clinical indications as of the date of the search.

Drug Type

Small molecule is a category of medicines consisting of organic chemical compounds – or more commonly, pills that are swallowed. Biologic is a category of medicines such as therapeutic proteins and monoclonal antibodies derived from living cells – or more commonly, drugs that are injected into the body.

Patents

Information on how patent data was sourced and validated is available at i-mak.org/patent-methods.

Patent Applications

The total number of patents filed on a product at the U.S. Patent and Trademark Office (USPTO), as of the date of the search.

Patents Granted

The number of patents that have been granted to a product, regardless of the current status of the patent. This includes active and expired patents.

% Filed After FDA Approval

The number of patent applications with a filing date after the date of a drug’s first FDA approval, divided by the total number of patent applications for the drug.

% Listed on the Orange / Purple Book

The percentage of patent applications that were listed on the Orange Book as of the date of the patent search.

Duration of Patent Protection

The number of years from the filing date of the first granted patent to the expiry date of the last granted patent.

Patent Applications in U.S. vs E.U.

The total number of patent applications filed at the USPTO, divided by the total number of patent applications filed at the European Patent Office (EPO), as of the date of the patent search.

Patents Granted in the U.S. vs. the E.U.

The total number of patents issued at the USPTO divided by the total number of patents issued at the EPO, as of the date of the patent search.

APPROVALS

Branded product approval dates reflect initial regulatory authorization in both the U.S. and E.U. For generics and biosimilars, U.S. dates reflect first commercial market entry, not FDA approval, as products are sometimes approved but not launched. E.U. dates reflect EMA marketing authorization and confirmed product availability in one or more European countries. Generic and biosimilar dates are current as of March 2026

First Branded Product U.S./FDA Approval Date

Initial FDA approval date for the drug. Source: drugs.com/history

First Branded Product E.U./EMA Approval Date

Initial European Medicines Agency marketing authorization date. Source: EMA medicines database and company press releases/SEC disclosures.

First Generic/Biosimilar on the U.S. Market

Date that the first generic or biosimilar competitor became commercially available to patients in the United States. This reflects actual market entry, not FDA approval. FDA approval and market entry can diverge significantly — a product may receive regulatory clearance but remain unlaunched due to ongoing patent litigation, manufacturing delays, or commercial decisions. Source: Company press releases, trade publications, analyst reports, and earnings updates. Current as of March 2026.

First Generic/Biosimilar on the E.U. Market

Date of first EMA marketing authorization for a generic or biosimilar competitor in Europe. Unlike the U.S. column, which uses market entry dates, the E.U. column reflects EMA marketing authorization and confirmed product availability in one or more European countries. EMA authorization triggers national pricing and reimbursement negotiations that proceed on different timelines across member states, making a single pan-European launch date unavailable. Source: EMA European Public Assessment Report (EPAR) records; company press releases and trade publications. Current as of March 2026.

PRICE

WAC is the manufacturer’s published list price and does not reflect rebates, discounts, or net prices paid by payers or patients. No average is shown for highest single-year WAC increase; unlike the WAC multiple and percentage of years exceeding inflation, which are normalized rates comparable across drugs, an average of individual peak values does not produce a meaningful summary figure.

Beginning Year of Analysis

The first calendar year for which confirmed WAC price data is available for each drug, as reported by 46brooklyn Research. This year varies by drug and serves as the starting point for all cumulative price calculations. Source: 46brooklyn Research using Elsevier’s Gold Standard Drug Database (www.46brooklyn.com/branddrug-boxscore).

Cumulative WAC Increase (Confirmed Years Only)

Absolute cumulative change in Wholesale Acquisition Cost (WAC) from the first year of confirmed price data through 2025, for which 46brooklyn data is available. Years for which data are not available are excluded from this calculation. Source: 46brooklyn research using Elsevier’s Gold Standard Drug Database (www.46brooklyn.com/branddrug-boxscore).

Cumulative CPI Inflation (Matched Years Only)

Cumulative U.S. inflation compounded across only those years for which confirmed WAC price data exists, calculated using year-over-year changes in the Bureau of Labor Statistics Consumer Price Index for All Urban Consumers (CPI-U). This matched-year approach ensures that WAC and inflation figures cover the identical set of years.. Source: U.S. Bureau of Labor Statistics, CPI-U annual averages (series CPIAUCSL; www.bls.gov).

WAC Multiple vs. Matched Inflation

Calculated as the cumulative WAC increase divided by the cumulative matched-year CPI inflation over the same set of years. A value greater than 1.0 indicates the drug’s list price increased faster than general consumer inflation during the years for which data is available.

% of Years WAC Exceeded Inflation

The share of confirmed data years in which that year’s WAC price increase exceeded that year’s annual CPI-U inflation rate. A higher percentage indicates more consistent above-inflation pricing behavior. Source: 46brooklyn research; BLS CPI-U annual rates.

Highest Single-Year WAC increase

The largest annual WAC price increase recorded across all years with confirmed data. This figure represents the peak pricing action taken in any single year and is independent of cumulative calculations. Source: 46brooklyn research using Elsevier’s Gold Standard Drug Database.

MEDICARE

Figures represent gross Medicare Parts D and B spending before manufacturer rebates and discounts. Where a drug is marketed under multiple formulations with the same brand name, spending and beneficiary data were combined into a single entry. Average growth figures for total spending and total beneficiaries exclude outlier values for Darzalex, Darzalex Faspro, and Skyrizi, whose growth rates reflect launches during or just before the 2021–2024 measurement period rather than sustained price or utilization trends.

Total Spending 2024

Aggregate Medicare Part D and Part B expenditures for 2024. Figures represent gross spending before manufacturer rebates and discounts. Products with the same active ingredient were combined where applicable. Source: CMS Medicare Drug Spending Dashboard (data.cms.gov).

Total Beneficiaries 2024

The total number of Medicare beneficiaries who used the drug in 2024, combining Part D and Part B enrollment counts where applicable. Source: CMS Medicare Drug Spending Dashboard.

Spending Per Beneficiary (2024)

Average per-beneficiary expenditure under Medicare Parts D and B for 2024, calculated as total spending divided by total beneficiaries. Source: CMS Medicare Drug Spending Dashboard.

Growth in Total Spending (2021–24)

Cumulative percentage increase in gross Medicare Parts D and B expenditures from 2021 to 2024. Source: CMS Medicare Drug Spending Dashboard.

Growth in Total Beneficiaries (2021–24)

Cumulative percentage increase in the number of Medicare beneficiaries using each drug from 2021 to 2024. This measure captures changes in utilization volume independent of price changes. Source: CMS Medicare Drug Spending Dashboard.

Growth in Average Spending Per Beneficiary (2021–24)

Cumulative percentage change in average per-beneficiary spending from 2021 to 2024. This measure isolates per-patient cost growth from changes in the total number of users. Source: CMS Medicare Drug Spending Dashboard.

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