The Federal Trade Commission is seemingly seeking to clear the path for generic versions of the weight loss drug Ozempic — but there will be a long road ahead before cheaper versions of the injectable diabetes treatment can hit the shelves.
In a warning letter sent to several drugmakers, including Ozempic's Denmark-based manufacturer Novo Nordisk, the FTC announced that it plans to challenge so-called "junk patents" that keep the prices for medications artificially high.
A cheaper version of Ozempic could have considerable implications. The drug has shown to be a highly effective way to lose weight and researchers have found it can even slow the progression of kidney disease.
However, thanks to its hefty price of around $1,000 a month in the US, it remains inaccessible to many — despite costing a tiny fraction of that to produce.
In its efforts to open doors for more affordable, generic versions of the drug and others like it, the FTC is pushing back against manufacturers' "improper or inaccurate listing of patents" in the Food and Drug Administration's "Orange Book," which lists the patents associated with various brand-name drugs.
According to the FTC, pharma companies needlessly include way more patents than a given drug needs on everything from intellectual property to manufacturing processes, to prevent generics from being made.
Case in point, in a 2022 investigation, the Initiative for Medicines, Access, and Knowledge (I-MAK) found that the top ten best-selling medications in the United States held a whopping 74 patents on average per drug, with some having junk patent counts in the hundreds.
While generic drugmakers can challenge these extraneous patents, the manufacturers of brand-name drugs can choose to fight them in court — and as the Wall Street Journal explains in its reporting on the FTC's new campaign, it can delay the approval of generics for 30 months.
"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 statement. "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."
Along with Novo Nordisk, the FTC sent a letter to AstraZeneca over its own injectable diabetes drug called Bydureon BCise. The makers of the Baqsimi nasal spray, which helps type-1 diabetics with severe hypoglycemia, were also sent a letter, along with eight other companies whose medications treat illnesses like asthma and COPD.
Now that the FTC has sent out its letters, each company has 30 days to either amend their listings, withdraw them, or testify under threat of perjury that the listings comply with laws barring such extraneous patents.
That means it will be a while before generic drugmakers can challenge Novo Nordisk on its near-monopoly on Ozempic — but at very least, regulators are already laying the groundwork.
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