Sources and methods for the patent, pricing, spending, and market data in Overpatented, Overpriced 2025
Drug Information
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 2024.
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 May-October 2024
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, and also revoked, lapsed, under appeal, ceased, and not in force patents – as all of these patents were granted.
% 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
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 May-October 2024.
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 May-October 2024.
Price
Total Price Increase Since Launch (WAC)
Absolute change in Wholesale Acquisition Cost from FDA approval through 2024. Source: 46Brooklyn research using Elsevier’s Gold Standard Drug Database (www.46brooklyn.com/branddrug-boxscore).
Cumulative U.S. Inflation (launch-2024)
Cumulative inflation from drug launch through end of 2024. Source: www.usinflationcalculator.com.
Price Increase Exceeds Inflation (Fold-multiple):
Calculated as total WAC price increase from launch through 2024 divided by cumulative inflation over the same period.
Medicare Increase in Spending Per Dosage Unit (2019-23)
Source: CMS Medicare Drug Spending Dashboard (https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug).
Spending
Medicare Total Spending Rank 2023
Ranking based on combined Medicare Part D and Part B spending for 2023. Products with the same active ingredient were combined for ranking purposes.
Medicare Total Spending 2023
Aggregate Medicare Part D and Part B expenditures for 2023. Figures represent gross spending before manufacturer rebates and discounts.
Medicare Spending Per Beneficiary 2023
Average per-beneficiary expenditure under Medicare Parts D and B for 2023, calculated as total spending divided by enrolled beneficiaries. Source: CMS Medicare Drug Spending Dashboard.
Growth in Medicare Total Spending (2019-23):
Cumulative percentage increase in gross Medicare Parts D and B expenditures from 2019-2023.
Total U.S. Revenues (launch – 2024)
Cumulative U.S. revenue from launch through December 2024. Source: SEC filings, company earnings reports, and Bloomberg LP.
Share of Drugmaker’s U.S. Revenue (2024)
Product’s percentage of company’s total 2024 U.S. pharmaceutical revenue. Source: SEC filings, company earnings reports, and Bloomberg LP. The percentage represents the product’s relative contribution to the drugmaker’s domestic pharmaceutical business.
Market
First U.S./FDA Approval Date
Initial FDA approval date. Source: Orange Book and Drugs.com.
First EMA/EU Approval Date
Initial European Medicines Agency approval date. Source: EMA database and company press releases/SEC disclosures.
First Generic/Biosimilar on the U.S. Market
Launch date of first generic or biosimilar competitor. Source: Company press releases, trade publications, analyst reports, and earnings updates. Current as of April 2025.
First Generic/Biosimilar on the E.U. Market
Launch date of first generic or biosimilar competitor in Europe. Source: Company press releases, trade publications, analyst reports, and earnings updates. Current as of April 2025.