FTC challenges bogus patent listings: Is your prescription’s price high due to pharma fraud?

Why are your medication prices so high? For one, because there are no regulations in the U.S. to cap the price of prescription drugs, your particular therapy may lack the competition necessary to lower its cost. Despite drug companies' notorious maneuvers to retain exclusivity through patent strategies such as evergreening and pay-for-delay, recent warnings from the U.S. Federal Trade Commission (FTC) to multiple pharmaceutical manufacturers reveal that their efforts extend beyond these tactics. Drug companies have prolonged their brands cornering the market by (perhaps intentionally) botching their listings in the FDA’s Orange Book, a comprehensive catalog of drug products approved by the United States Food and Drug Administration as safe and effective. This fraudulent behavior inevitably leads to inflated drug prices, leaving Americans puzzled why they can order the same branded medication from abroad for a fraction of the U.S. price – or why the generic is available in Canada or Europe years before it hits U.S. pharmacy shelves.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” said FTC Chair Lina Khan in a press release issued in April 2024. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”

For patients struggling to afford these medications due to the named drug companies’ insidious exclusivity tactics, PharmacyChecker has organized the chart below based on the list of the drugs detailed in the April 2024 FTC warning letters, along with their manufacturing and international mail order pricing information. Among the recently identified “junk” listings are brand drugs prescribed for diabetes, asthma, weight loss, and COPD, including popular inhalers, Breo Ellipta and Trelegy Ellipta, and blockbuster weight loss drug, Ozempic. In November 2023, the Commission challenged over 100 listings, including Restastis and epinephrine autoinjectors. At present, those listings are not included in our chart.

Interpreting our chart

PharmacyChecker lists the drugs in alphabetical order with the following details:

Brand drug name with an inaccurate or improper listing in the FDA Orange Book

Name of the Marketing Authorization Holder that received an FTC warning letter 

Drug manufacturing location for the U.S. market

Online Pharmacy Price from a PharmacyChecker-accredited pharmacy website that provides international mail order

Location of the international dispensing pharmacy

Name of the Marketing Authorization Holder in the country of the PharmacyChecker-accredited dispensing pharmacy

Brand Name Drugs With Inaccurate Orange Book Listings – International Price and Manufacturer Comparison (2024)

PharmacyChecker Research 2024. *Due to patient safety concerns, PharmacyChecker maintains the most rigorous standards for international shipping of products requiring refrigeration. To ship refrigerated products, mail-order pharmacies must meet PharmacyChecker Policy 16-03 Refrigerated Medications: Shipping Requirements. Currently, no websites accredited through the PharmacyChecker Verification Program are permitted to market refrigerated products to consumers.