Sources and methods for the patent, pricing, spending, and market data in America’s Top Selling Drugs
Drug Information
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 2021.
Company: The principal company marketing the branded version of the drug in the U.S., along with any significant international partners that may also receive income from sales in the U.S.
Drug Type: Small molecule is a category of medicines comprised 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.
Granted Patents: The number of patents that have been granted to a product, regardless of current status. This includes active and expired patents, and also revoked, lapsed, under appeal, ceased, and not in force patents, as 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.
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. Duration is calculated as the number of days between the two dates, divided by 365. For example, the duration of patent protection on Keytruda is 37.3 years (the first granted patent was filed on 3/7/2002 and the last granted patent expires 6/26/2039, a duration of 13,625 days, which divided by 365 is 37.3 years).
Patent Applications in U.S. vs E.U.: The total number of patent applications filed at the U.S. Patent and Trademark Office (USPTO), divided by the total number of patent applications filed at the European Patent Office (EPO).
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.
Price
Total Price Increase Since Launch (WAC): The absolute change in the Wholesale Acquisition Cost (WAC) price set by the drugmaker from the date of the first FDA approval to 2021. WAC from 2012 to 2022 is based on the first quarter price and was accessed on the SSR Health Database. Launch prices earlier than 2012 were researched on a drug-by-drug basis.
Total 5yr Price Increase (WAC, 2016-2021): The absolute change in the WAC price set by the drugmaker over a five-year span from 2016 to 2021. For Biktarvy, which was approved in 2018, the price increase was calculated from 2018 to 2021.
5yr Price Increase vs. Inflation: Multiple is calculated as the absolute WAC price increase, divided by the absolute change in inflation from 2016 to 2021. Inflation data sourced from www.usinflationcalculator.com.
Medicare Avg. Annual Growth Rate in Spending Per Dosage Unit (2016-20): Data obtained from the Centers for Medicare and Medicaid Services (CMS) Medicare Drug Spending Dashboard, available at https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug.
Spending
Overall U.S. Spend 2021 Rank: Ranking based on 2021 U.S. sales reported by manufacturers in SEC filings, earnings reports, or compiled from Bloomberg LP.
Medicare Top 12 Total Spending Rank: Ranking based on the Medicare Part D Spending by Drug and Medicare Part B Spending by Drug datasets from the Centers for Medicare & Medicaid Services. Ranking is based on combined Part D and Part B annual spending for 2021, the latest year for which data are available. Products with multiple listings for the same active ingredient were combined for the overall ranking; these included Humira (9 products), Lantus (2 products), and Novolog (4 products).
Medicare + Medicaid Top 12 Total Spending Rank: Ranking based on the Medicare Part D Spending by Drug dataset, the Medicare Part B Spending by Drug dataset, and the Medicaid Drug Spending dashboard from the Centers for Medicare & Medicaid Services. Ranking is based on combined Part D, Part B, and Medicaid annual spending for 2021, the latest year for which data are available.
Medicare Spending Per Beneficiary (2021): Spending data obtained from the CMS Medicare Drug Spending Dashboard available at data.cms.gov, and reflects the latest year for which data are available.
Total U.S. Revenues Since Launch ($ billions): Reflects the sum of annual U.S. drug revenues reported by each product’s manufacturer in SEC filings, earnings reports, or compiled from Bloomberg LP through Q1 2022. For certain drugs, U.S. share of revenues is estimated in early years when geographic split is not provided (e.g., Revlimid, Lantus, Avastin, Herceptin, Rituxan).
Share of Co.’s 2021 U.S. Pharma Revenue: 2021 U.S. product sales as a percentage of total annual U.S. pharmaceutical sales, as reported by company’s SEC filings, earnings reports, or compiled from Bloomberg LP.
Market
First U.S./FDA Approval Date: First approval date for a drug by the FDA, sourced from the Orange Book and Drugs.com.
First EMA/EU Approval Date: First approval date for a drug by the European Medical Agency (EMA), sourced from the EMA database and through drug-by-drug searches for company press releases/ SEC disclosures.
First Generic/Biosimilar on the U.S. Market: Dates for biosimilar approvals and launches were researched on a drug-by-drug basis using sources such as generic drug company press releases and filings, biopharmaceutical trade press, analyst reports, and quarterly earnings updates by branded drug companies. Information current as of Jun 2024.
First Generic/Biosimilar on the E.U. Market: Dates for biosimilar approvals and launches were researched on a drug-by-drug basis using sources such as generic drug company press releases and filings, biopharmaceutical trade press, analyst reports, and quarterly earnings updates by branded drug companies. Information current as of Jan 2024.