Estrace generics — when can they launch?
Estrace (ESTRADIOL) · Pfizer · 101 active US patents · 1 expired
Where Estrace sits in the generic timeline
Imminent generic cliff: earliest active US patent for Estrace expires in 2028 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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 — 57 patents
- Formulation — 33 patents
- Composition of Matter — 11 patents
FDA U-codes carved out by Estrace 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-2086 | (no description) |
U-2439 | (no description) |
U-2316 | (no description) |
U-2317 | (no description) |
U-3129 | (no description) |
U-2360 | (no description) |
Sample patent estate
Showing 6 of 101 active US patents. View full estate on the Estrace drug page →
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This patent protects a transdermal drug delivery system for administering estrogen, comprising a polymer matrix and estrogen.USPTO title: Transdermal estrogen device and delivery
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This patent protects a transdermal drug delivery system for administering estrogen, comprising a polymer matrix and estrogen.USPTO title: Transdermal estrogen device and delivery
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This patent protects a method of using transdermal drug delivery systems for the administration of estrogen.USPTO title: Transdermal estrogen device and delivery
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This patent protects a transdermal drug delivery system for administering estrogen, comprising a polymer matrix and estrogen.USPTO title: Transdermal estrogen device and delivery
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This patent protects a transdermal drug delivery system for administering estrogen, comprising a polymer matrix and estrogen.USPTO title: Transdermal estrogen device and delivery
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This patent protects a transdermal drug delivery system for administering estrogen, comprising a polymer matrix and estrogen.USPTO title: Transdermal estrogen device and delivery
Sources
- FDA Orange Book — patents listed against Estrace (NDA filed 1975)
- Estrace drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2028 — 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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