OTP Exclusive: The US Is One Massive Step Closer to Generic Wegovy , Here's Why

What this week’s quiet court ruling really means for cheaper semaglutide, and how soon it could arrive

On July 22, a federal judge handed Mylan Pharmaceuticals a major win in its 2+ year patent fight with Novo Nordisk, the maker of Wegovy. This on the heels of Canadian generics coming in 2026, and India’s Dr. Reddy’s announcement of global generic semaglutide launches in 87 countries next year.

But today we are talking about generic semaglutide, right here in the USA.

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This is indeed a big moment. But it’s not the finish line. Let’s unpack whats going on…

The case at the center of it all

Here’s the situation. Mylan wants to make a generic version of Wegovy, the GLP-1 medication with semaglutide that’s become one of the most powerful tools in the fight against obesity.

But to do that, they have to get through the Hatch Waxman patent gauntlet.

Novo Nordisk currently has five patents listed for Wegovy in the FDA’s Orange Book. Mylan filed a challenge to all of them, hoping to break down the wall and bring a cheaper option to market. This week, they officially won their first battle, knocking out 1 of 5, Patent No. 9,764,003.

That’s big. But there are still four more to go.

What the judge actually ruled

The patent Mylan beat this week covers a method of using semaglutide

once a week to reduce body weight without combining it with another therapeutic agent. Novo claimed Mylan’s label would indirectly encourage that exact method, meaning it would infringe the patent.

But the judge disagreed. He said the proposed label does not tell doctors to avoid other medications. In fact, it mentions co-administering semaglutide with insulin and other treatments.

The takeaway? The court ruled that Mylan is not infringing on that particular

patent. That’s one major legal block removed.

But There's More…

To actually bring a generic Wegovy to market in the United States, Mylan must either:

1. Win on the remaining four patents in court, or

2. Settle with Novo Nordisk, negotiating an agreed-upon launch date, or

3. Wait until all the patents expire, which could stretch out to 2027 or beyond

So while this ruling clears a lane, it doesn’t clear the runway.

So when could a generic actually launch?

Here’s the best-case and more likely-case timeline based on everything we know:

🟢 Best case:If Mylan wins on the remaining patents or settles quickly, and the FDA approves their ANDA, we could see generic semaglutide launch as early as late 2025. This would mean all stars align, fast settlements, no delays, FDA green light. Unlikely.

🟡 More realistic case:If litigation drags or settlements push back the date, a generic might not arrive until 2026 or 2027. That’s still earlier than the full patent expiration date, but not the overnight breakthrough some headlines are implying.

🔴 Worst case:If Novo defends every remaining patent successfully, generic access could be blocked until the last expiration, possibly 2032 or later, depending on patent extensions.

What this means for the GLP-1 movement

Cheaper and more accessible semaglutide would change everything. It would put real weight loss tools within reach for millions. And this court win is a step in that direction. But we have to be clear about where we are on the map. This was mile one of a marathon.

Big Pharma rarely gives up ground without a fight. Novo will defend the remaining patents with everything they’ve got. Mylan will need to stay aggressive in court or strike a deal behind closed doors.

And we’ll be watching.

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Let’s keep going.

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