Fda Says Shortage Of Weight Loss Drug Ingredients Is Over, Compounders Are Nervous

The FDA said yesterday that after two years, there is no longer a shortage of injection products for semaglutide, the key ingredient in Novo Nordisk A/S’s blockbuster weight loss and diabetes drugs. The announcement means the countdown has begun for companies like Hims & Hers to either stop making their cheaper, compounded versions or, much more likely, to fight back.

Hims & Hers, which you might recognize from its flashy Super Bowl ad smashed between junk food and beer spots, is at the top of the $1 billion-a-year weight loss drug compounding industry.

The compounding of drugs is a fairly common practice to make customized copy-cat versions of brand-name drugs. They’re often personalized for patients, so if someone is allergic to an ingredient in a drug, for example, a pharmacist can tweak the formula without getting hit with IP claims from the drugmaker. But compounding is also allowed when drugs are facing shortages—like the highly popular Wegovy and Ozempic were. That’s created a big market because:

• Hims & Hers is able to sell its weight loss medicine for less than $200 a month.
• That’s a fraction of the cost of the name brand drugs from Novo, which clock in at around $1,000 per month without insurance.

But…Pharma giants and regulators claim copycats can be a serious safety risk. Compounded drugs don’t go through the same quality checks that are required of brand-name or generic drugs.

With the market for GLP-1 drugs expected to be $150 billion a year by 2033, drugmakers are clamping down on anyone trying to eat into their profits. Novo Nordisk has filed 50+ lawsuits accusing compounders and clinics of trademark infringement.

Looking ahead…The FDA said compound drug makers have 60 to 90 days (depending on their facility) to close up shop. Hims & Hers CEO Andrew Dudum said in a post on X yesterday that the company would continue to monitor supply constraints, but will still offer “personalized treatments as allowed by law to meet patient needs.” Expect more lawsuits.—MM