LETROZOLE generics — when can they launch?
LETROZOLE (LETROZOLE) · · 11 active US patents · 0 expired
Where LETROZOLE sits in the generic timeline
Imminent generic cliff: earliest active US patent for LETROZOLE 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.
- Composition of Matter — 4 patents
- Method of Use — 4 patents
- Formulation — 3 patents
FDA U-codes carved out by LETROZOLE 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-2505 | (no description) |
U-3998 | (no description) |
U-3264 | (no description) |
Sample patent estate
Showing 6 of 11 active US patents. View full estate on the LETROZOLE drug page →
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This patent protects pyrrolopyrimidine compounds and their derivatives that inhibit protein kinases, useful in treating proliferative diseases.USPTO title: Pyrrolopyrimidine compounds and their uses
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This patent protects methods of using pyrrolopyrimidine compounds to treat or prevent symptoms of various disorders, including cancer, transplant rejections, and autoimmune diseases.USPTO title: Pyrrolopyrimidine compounds and their uses
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This patent protects the use of pyrrolopyrimidine compounds for treating or preventing symptoms of cancer, transplant rejections, and autoimmune diseases.USPTO title: Pyrrolopyrimidine compounds and their uses
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This patent protects pyrrolopyrimidine compounds and their uses in treating protein kinase-associated disorders, cancer, transplant rejections, and autoimmune diseases.USPTO title: Pyrrolopyrimidine compounds and their uses
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This patent protects novel pyrrolopyrimidine compounds and their uses, including pharmaceutical compositions and treatments for diseases associated with CDK 4 inhibition.USPTO title: Pyrrolopyrimidine compounds and their uses
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This patent protects a process for making a specific compound, its novel salts, and pharmaceutical compositions containing it, which is related to the drug substance LETROZOLE.USPTO title: Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-D]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof
Sources
- FDA Orange Book — patents listed against LETROZOLE (NDA filed 1997)
- LETROZOLE drug profile — full patent estate, indications, clinical trials, pricing
- 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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