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

Written by Lucia Mueller | Posted May 08, 2024

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

Click on the drug name to compare pricing across U.S. retail and international mail-order pharmacies, where available.

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

Click on the name of the drug company to read the official warning letter issued by the Federal Trade Commission.

Drug manufacturing location for the U.S. market

Click on the country name to view a U.S. label for the drug as provided by the National Library of Medicine. 90% of the drug products marketed in the United States are manufactured elsewhere. 

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

Prices in the chart are per inhaler unless noted otherwise. All online pharmacy prices listed below, and across PharmacyChecker.com, are those provided by pharmacies that are accredited and continuously monitored in the PharmacyChecker International Pharmacy Verification Program. Most online pharmacies in the International Pharmacy Verification Program provide global shipping, which has been factored into the listed price. 

Location of the international dispensing pharmacy

The accredited websites in PharmacyChecker’s Verification Program partner with dispensing pharmacies located in Canada, Australia, India, Mauritius, New Zealand, Turkey, the UK, and the United States. PharmacyChecker standards require that these dispensing partners are also monitored by the Verification Program and that the websites with which they partner are transparent to patients and consumers about the location from which their medicine is being shipped. 

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

It's quite common for the same pharmaceutical company to market the same drug across different countries -- sometimes with a slight name change. This is the case for a drug marketed by Teva Pharmaceuticals: they brand the product as ArmonAir Respiclick in the United States and then Aermony Respiclick in Canada. Our investigation shows the U.S. brand is manufactured in Ireland, whereas the Canadian product is likely manufactured in Canada. GlaxoSmithKline markets their inhaler product fluticasone furoate/vilanterol under the name Breo Ellipta in the U.S. and Relvar Ellipta in Turkey. Covis Pharma manufactures U.S.-sold Duaklir Pressair in Sweden and Canadian-sold Duaklir Genuair in Switzerland. Boehringer Ingelheim opts to market their inhaler (tiotropium bromide and olodaterol) spelled with a "t" in the U.S. (Stiolto Respimat) versus a "p" in the UK (Spiolto Respimat). And, while branded Utibron marketed by Novartis has been discontinued in the United States, their Ultibro Breezehaler is sold in New Zealand dispensing pharmacies.
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Brand Name Drugs With Inaccurate Orange Book Listings – International Price and Manufacturer Comparison (2024)

Drug - U.S. Brand name (International brand name) Drug Company with U.S. Marketing Authorization Manufacturing Location for U.S. Market International Mail Order Pharmacy Price International Dispensing Pharmacy Location Drug Company with Marketing Authorization in the International Dispensing Pharmacy Location
AirDuo Digihaler Teva Pharmaceutical Industries Ltd. Ireland N/A    
AirDuo Respiclick Teva Pharmaceutical Industries Ltd. Ireland N/A    
Anoro Ellipta GlaxoSmithKline Singapore; UK $35.65 Turkey GlaxoSmithKline
ArmonAir Digihaler Teva Pharmaceutical Industries Ltd. Ireland N/A    
ArmonAir Respiclick (Aermony Respiclick) Teva Pharmaceutical Industries Ltd. Ireland $49.98 Canada Teva Pharmaceuticals
Baqsimi Amphastar Pharmaceuticals Inc. USA $219.06 per pack Canada Eli Lilly
Breo Ellipta (Relvar Ellipta) Glaxo Group Limited UK $20.94 Turkey GlaxoSmithKline
Bydureon Pen AstraZeneca AB USA; Germany N/A due to refrigeration*    
Duaklir Pressair (Duaklir Genuair) Covis Pharma GMBH Sweden $108.85 Canada Covis Pharma GmbH.
Incruse Ellipta Glaxo Group Limited Singapore $60.65 UK GlaxoSmithKline
Ozempic Novo Nordisk Inc. Denmark N/A due to refrigeration*    
QVAR Redihaler Norton (Waterford) Limited Ireland $53.99 New Zealand Inova Pharmaceuticals
Saxenda Novo Nordisk Inc. Denmark N/A due to refrigeration*    
Seebri Novartis Pharmaceuticals Corp. Discontinued in the United States $71.12 UK Novartis
Stiolto Respimat (Spiolto Respimat) Boehringer Ingelheim Pharmaceuticals, Inc. Germany $79.32 UK Boehringer-Ingelheim
Striverdi Respimat Boehringer Ingelheim Pharmaceuticals, Inc. Germany $85.95 UK Boehringer Ingelheim
Trelegy Ellipta GlaxoSmithKline UK $35.19 Turkey GlaxoSmithKline
Tudorza Pressair Covis Pharma GMBH USA $95.99 Canada Covis Pharma GmbH.
Utibron (Ultibro Breezehaler) Novartis Pharmaceuticals Corp. Discontinued in the United States $93.32 New Zealand Novartis
Victoza Novo Nordisk Inc. Denmark N/A due to refrigeration*    

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.

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