What’s Really Happening With the FDA, Novo, and Hims Over Oral Semaglutide?

The weight-loss drug world is buzzing because a legal and regulatory battle just heated up between a big pharma company and a telehealth drug seller — and lots of people are confused about what it means. Let’s break it down in plain language.

Semaglutide Isn’t Just Any Drug

Semaglutide is the active ingredient in some of the most talked-about weight-loss medicines out there (like Wegovy and Ozempic). It’s proven to help people lose weight and manage diabetes. In late 2025, the FDA approved an oral version of Wegovy — meaning people can take a pill instead of an injection. That was big news in this space.

Hims & Hers Tried to Sell a Cheaper Copycat

Hims & Hers, a telehealth company that sells medications online, announced that it was going to sell its own version of an oral semaglutide pill for weight loss — starting at $49 for the first month. That’s much cheaper than the brand-name version.

This pill wasn’t FDA-approved. Instead, it was a compounded drug, meaning a pharmacy mixes up the active ingredients based on prescriptions. Compounded drugs can be very useful when a patient truly needs something unique (like a different dose), but they aren’t reviewed by the FDA in the same way that “official” drugs are.

The FDA and Novo Didn’t Like That

The FDA stepped in quickly and warned that products like this can’t be marketed as if they’re the same as FDA-approved drugs. The agency also said it plans to take steps to restrict key ingredients used in these compounded drugs if they’re being mass marketed, because the FDA can’t verify their quality, safety, or effectiveness.

Shortly after that, Hims pulled back and stopped offering the oral semaglutide pill they had planned to sell.

The API Issue: Why This Is a Big Deal

Here’s the part many people are not talking about enough.

The FDA has indicated it may restrict access to the Active Pharmaceutical Ingredient, also called the API, used to make compounded semaglutide.

The API is the raw ingredient that pharmacies purchase in order to compound the medication.

If access to that ingredient is limited or cut off:

• Legitimate compounding pharmacies could lose the ability to make semaglutide

• Patients who rely on compounded versions could face sudden supply disruptions

• Prices could rise quickly due to limited availability

• Access in cash-pay markets could tighten dramatically

In simple terms: if pharmacies cannot obtain the raw ingredient, they cannot produce the medication.

That would create major ripple effects for people who depend on compounded options because they:

• Do not have insurance coverage

• Cannot afford brand-name pricing

• Do not qualify under strict insurance criteria

This is not just a legal fight between companies. It has real-world implications for access and affordability.

Novo Nordisk Filed a Lawsuit

But that wasn’t the end of it. Novo Nordisk — the Danish company that makes Wegovy and owns the patents on semaglutide — filed a patent infringement lawsuit against Hims & Hers. They say:

• Hims was selling and promoting drug products that use semaglutide in ways that violate Novo’s patents.

• These products weren’t FDA-approved, yet they were marketed like they were safe and effective alternatives.

• That’s not just unfair competition — it can also be dangerous for patients.

Novo is asking a court to block Hims from selling these compounded semaglutide products and is seeking damages for the infringement.

Why This Matters

This fight isn’t just about one pill. It’s really about how new weight-loss drugs like GLP-1 therapies are regulated, how patients get access to them, and how far companies can go in selling cheaper alternatives without FDA approval.

Here’s the key tension:

Supporters of compounding say it’s important for patient access and personalization.

The FDA and Novo argue that once shortages are over and safe, approved versions are available, broad “mass-produced” compounded alternatives shouldn’t be marketed as equal — because that could put people at risk and undercut the drug approval system that ensures safety and effectiveness.

Bottom Line for Patients

• Hims tried to sell a cheap, unapproved semaglutide pill.

• The FDA warned against marketing these kinds of products.

• Novo Nordisk sued Hims for patent infringement.

• Hims stopped offering the pill for now, but the legal battle is just beginning.

This situation is still evolving and will have a direct impact on millions of people. Stay tuned for more….