ELINZANETANT generics — when can they launch?
ELINZANETANT (ELINZANETANT) · · 6 active US patents · 0 expired
Where ELINZANETANT sits in the generic timeline
All listed Orange Book patents for ELINZANETANT 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 — 4 patents
- Composition of Matter — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by ELINZANETANT 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-3622 | (no description) |
U-4402 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the ELINZANETANT drug page →
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This patent protects novel pyridine derivatives, their pharmaceutically acceptable salts or solvates, and pharmaceutical compositions containing them.USPTO title: Pyridine derivatives and their use in the treatment of psychotic disorders
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This patent protects the use of dual NK-1/NK-3 receptor antagonists for treating sex-hormone dependent diseases.USPTO title: Uses of dual NK1/NK3 receptor antagonists for treating sex-hormone diseases
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USPTO title: Soft gelatin capsule formulation
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This patent protects a method of treating certain sex hormone-dependent diseases using a soft gelatin capsule containing NK1 and NK3 receptors antagonists.USPTO title: Method of treating certain sex hormone-dependent diseases administering a soft gelatin capsule comprising NK1 and NK3 receptors antagonists
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USPTO title: Method of treatment of symptoms of menopause
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This patent protects methods of treating vasomotor symptoms in a female subject by administering elinzanetant with a moderate CYP3A4 inhibitor.USPTO title: Methods of treatment with elinzanetant
Sources
- FDA Orange Book — patents listed against ELINZANETANT (NDA)
- ELINZANETANT 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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