The Federal Trade Commission (FTC) is intensifying its efforts to challenge numerous pharmaceutical patent listings, aiming to facilitate the availability of more affordable alternatives to brand-name drugs, including blockbusters like Novo Nordisk A/S's (NYSE:NVO) Ozempic and Victoza.

What Happened: The FTC is disputing "junk patent listings" for diabetes, weight loss, asthma and COPD drugs.

This initiative represents the latest endeavor against what the agency perceives as patent tactics drugmakers employ to hinder generic competition.

At the center of the issue is the Orange Book, a Food and Drug Administration (FDA) publication containing patents relevant to brand-name pharmaceuticals.

According to a law designed to promote generics, successfully challenging listed patents can grant a period of exclusivity to generics makers before other generics are approved.

However, if a brand-name manufacturer decides to contest a challenge to an Orange Book patent in court, it can delay the approval of generics for 30 months, the Wall Street Journal noted.

To promote competition, the FTC said it is disputing these patent listings as improper or inaccurate.

Why It Matters: Improper Orange Book patent listings can delay cheaper generic alternatives from entering the market, keeping brand-name drug prices artificially high.

In its latest move, the FTC issued warning letters to 10 companies and notified the FDA that it disputes the accuracy or relevance of more than 300 Orange Book patent listings across 20 different brand name products.

The letters targeted what agency officials called "junk patent listings," including Novo Nordisk's diabetes medication Ozempic and various treatments from companies such as AstraZeneca Plc (NASDAQ:AZN), Boehringer Ingelheim and Novartis AG (NYSE:NVS).

"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. "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."

Other companies targeted include Amphastar Pharmaceuticals Inc (NASDAQ:AMPH) and Teva Pharmaceutical Industries Ltd (NYSE:TEVA).

What Critics Say: The Wall Street Journal highlighted critics' concerns about the potential implications of the FTC's actions, suggesting that delisted patents could increase the risk for generics entering the market, potentially leading to post-approval patent litigation.

Additionally, some critics attribute part of the problem to the U.S. Patent and Trademark Office, accusing it of issuing flimsy or duplicative patents.

Looking ahead, the FDA has promised new guidance this year to provide companies with further instructions on which patents to list in the Orange Book.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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