ELACESTRANT HYDROCHLORIDE generics — when can they launch?
ELACESTRANT HYDROCHLORIDE (ELACESTRANT HYDROCHLORIDE) · · 14 active US patents · 0 expired
Where ELACESTRANT HYDROCHLORIDE sits in the generic timeline
All listed Orange Book patents for ELACESTRANT HYDROCHLORIDE 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 — 12 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by ELACESTRANT HYDROCHLORIDE 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-3523 | (no description) |
U-3524 | (no description) |
Sample patent estate
Showing 6 of 14 active US patents. View full estate on the ELACESTRANT HYDROCHLORIDE drug page →
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This patent protects a compound represented by formula (I), a selective estrogen receptor modulator.USPTO title: Selective estrogen receptor modulator
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This patent protects a compound represented by formula (I), a selective estrogen receptor modulator.USPTO title: Selective estrogen receptor modulator
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This patent protects methods of treating estrogen receptor positive brain cancer and cancer resistant to estrogen receptor modulators using selective estrogen receptor degraders.USPTO title: Method of treating cancer using selective estrogen receptor modulators
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This patent protects methods of treating estrogen receptor positive brain cancer and cancer resistant to estrogen receptor modulators using selective estrogen receptor degraders.USPTO title: Method of treating cancer using selective estrogen receptor modulators
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This patent protects methods of treating estrogen receptor positive brain cancer and cancer resistant to estrogen receptor modulators using selective estrogen receptor degraders.USPTO title: Method of treating cancer using selective estrogen receptor modulators
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This patent protects methods of treating estrogen receptor positive brain cancer and cancer resistant to estrogen receptor modulators using selective estrogen receptor degraders.USPTO title: Method of treating cancer using selective estrogen receptor modulators
Sources
- FDA Orange Book — patents listed against ELACESTRANT HYDROCHLORIDE (NDA filed 2023)
- ELACESTRANT HYDROCHLORIDE 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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