Ozempic generics — when can they launch?
Ozempic (semaglutide) · Novo Nordisk · 178 active US patents · 39 expired
Where Ozempic sits in the generic timeline
All listed Orange Book patents for Ozempic have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 108 patents
- Formulation — 57 patents
- Composition of Matter — 13 patents
FDA U-codes carved out by Ozempic patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2202 | (no description) |
U-2628 | (no description) |
U-3469 | (no description) |
U-3355 | (no description) |
U-4389 | (no description) |
U-4418 | (no description) |
U-3161 | (no description) |
U-2580 | (no description) |
U-4388 | (no description) |
U-4443 | (no description) |
U-4446 | (no description) |
U-3162 | (no description) |
U-4387 | (no description) |
U-3861 | (no description) |
Sample patent estate
Showing 6 of 178 active US patents. View full estate on the Ozempic drug page →
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This patent protects a syringe device with mechanisms to prevent the ejection of a dose exceeding a set dose, including a safety mechanism in case of failure.USPTO title: Syringe device with a dose limiting mechanism and an additional safety mechanism
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This patent protects a syringe device with mechanisms to prevent the ejection of a dose exceeding a set dose, including a safety mechanism in case of failure.USPTO title: Syringe device with a dose limiting mechanism and an additional safety mechanism
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This patent protects a mechanism for preventing an injection device from setting a dose that exceeds the amount of medicament left in the device.USPTO title: Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
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This patent protects a syringe device with mechanisms to prevent the ejection of a dose exceeding a set dose, including a safety mechanism in case of failure.USPTO title: Syringe device with a dose limiting mechanism and an additional safety mechanism
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This patent protects a mechanism for preventing an injection device from setting a dose that exceeds the amount of medicament left in the device.USPTO title: Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
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This patent protects a syringe device with mechanisms to prevent the ejection of a dose exceeding a set dose, including a safety mechanism in case of failure.USPTO title: Syringe device with a dose limiting mechanism and an additional safety mechanism
Sources
- FDA Orange Book — patents listed against Ozempic (NDA filed 2017)
- Ozempic drug profile — full patent estate, indications, clinical trials, pricing
- Novo Nordisk patent portfolio
- Patent cliff 2026 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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