Ozempic May Cost Less Due to FTC Challenging 'Junk' Patents

The Federal Trade Commission is challenging drugmaker's 'junk' patents on weight loss medications, including Ozempic, which could lead to capped prices or usher in less expensive generic equivalents.

On April 30, the Federal Trade Commission (FTC) announced a crackdown on inaccurate or improper patent listings in the U.S. Food and Drug Administration's (FDA) Orange Book for several popular medications used to treat type 2 diabetes, obesity, asthma, and chronic obstructive pulmonary disease (COPD).

These include the top-selling diabetes/weight loss drugs Ozempic (semaglutide) and Saxenda (liraglutide).

The FTC sent warning letters to 10 pharmaceutical companies, including AstraZeneca, Novo Nordisk, Glaxo-Smith Kline, Novartis Pharmaceuticals Corp., and others. The drug makers have 30 days to withdraw or amend the listing or certify under penalty of perjury that the listing complies with applicable statutory and regulatory requirements.

"It is the responsibility of branded drug manufacturers to ensure that Orange Book submissions contain information only on the types of patents for which information should be submitted to FDA," said FDA Commissioner Robert M. Califf, M.D., in an FTC press release.

Reports suggest that a pharmaceutical company can use tactics involving "bogus" patents and FDA regulatory policies to prevent other companies from manufacturing cheaper generic versions of the brand-name drug.

This market exclusivity keeps prices high, adding more financial burden to people who need these medications.

"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 M. Khan. "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."

In November of last year, the FTC sent letters to 10 pharmaceutical firms challenging patent listings of specific asthma inhaler devices, Restasis, and EpiPens.

The move led to Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisting patents from the Orange Book. Later, AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline announced a plan to cap out-of-pocket costs for inhalers at $35.

How much does Ozempic cost?

The price of Ozempic is currently around $1,000 per month without insurance. Although health insurers may cover the drug if healthcare providers prescribe it for type 2 diabetes treatment, costs and coverage vary widely.

However, a recent analysis revealed that the cost of manufacturing semaglutide medications like Ozempic is much lower than the retail price. The data showed that drugmakers could sell a month's supply of Ozempic for around $5 or less per month and still profit.

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