Nexplanon generics — when can they launch?
Nexplanon (ETONOGESTREL) · · 5 active US patents · 0 expired
Where Nexplanon sits in the generic timeline
All listed Orange Book patents for Nexplanon 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.
- Formulation — 3 patents
- Method of Use — 2 patents
FDA U-codes carved out by Nexplanon 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-1 | Treatment of a specific disease/condition (broad) |
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the Nexplanon drug page →
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This patent protects an applicator for inserting a rod-like implant under the skin, with a handle that extends above the cannula for facilitating insertion and positioning.USPTO title: Applicator for inserting an implant
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This patent protects a kit for assembling a disposable applicator used to insert a rod-like implant under the skin of a human or animal.USPTO title: Kit for and method of assembling an applicator for inserting an implant
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This patent protects an X-ray visible drug delivery device for subdermal administration of a contraceptive or hormone replacement therapy.USPTO title: X-ray visible drug delivery device
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This patent protects an applicator for inserting a rod-like implant containing an active substance under the skin of a human or animal.USPTO title: Applicator for inserting an implant
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This patent protects an applicator for inserting a rod-like implant containing an active substance under the skin of a human or animal.USPTO title: Applicator for inserting an implant
Sources
- FDA Orange Book — patents listed against Nexplanon (NDA filed 2001)
- Nexplanon drug profile — full patent estate, indications, clinical trials, pricing
- 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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