Pemazyre generics — when can they launch?
Pemazyre (PEMIGATINIB) · Incyte Corp · 15 active US patents · 0 expired
Where Pemazyre sits in the generic timeline
Long-dated protection: earliest active US patent for Pemazyre extends to 2034 (~8 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 9 patents
- Composition of Matter — 6 patents
FDA U-codes carved out by Pemazyre 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-2809 | (no description) |
U-3464 | (no description) |
U-3568 | (no description) |
U-3569 | (no description) |
Sample patent estate
Showing 6 of 15 active US patents. View full estate on the Pemazyre drug page →
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This patent protects pharmaceutical compositions of tricyclic compounds that inhibit FGFR enzymes and are used to treat FGFR-associated diseases such as cancer.USPTO title: Substituted tricyclic compounds as FGFR inhibitors
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This patent protects pharmaceutical compositions of tricyclic compounds that inhibit FGFR enzymes and are used to treat FGFR-associated diseases such as cancer.USPTO title: Substituted tricyclic compounds as FGFR inhibitors
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This patent protects pharmaceutical compositions of tricyclic compounds that inhibit FGFR enzymes and are used to treat FGFR-associated diseases such as cancer.USPTO title: Substituted tricyclic compounds as FGFR inhibitors
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This patent protects tricyclic compounds that inhibit one or more FGFR enzymes and are useful in treating FGFR-associated diseases such as cancer.USPTO title: Substituted tricyclic compounds as FGFR inhibitors
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This patent protects tricyclic compounds that inhibit one or more FGFR enzymes and are useful in treating FGFR-associated diseases such as cancer.USPTO title: Substituted tricyclic compounds as FGFR inhibitors
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This patent protects tricyclic compounds that inhibit one or more FGFR enzymes and are useful in treating FGFR-associated diseases such as cancer.USPTO title: Substituted tricyclic compounds as FGFR inhibitors
Sources
- FDA Orange Book — patents listed against Pemazyre (NDA filed 2020)
- Pemazyre drug profile — full patent estate, indications, clinical trials, pricing
- Incyte Corp patent portfolio
- Patent cliff 2034 — 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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