Komzifti generics — when can they launch?
Komzifti (ZIFTOMENIB) · Kura · 8 active US patents · 0 expired
Where Komzifti sits in the generic timeline
Long-dated protection: earliest active US patent for Komzifti extends to 2036 (~10 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 — 5 patents
- Composition of Matter — 2 patents
- Formulation — 1 patent
FDA U-codes carved out by Komzifti 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-4350 | (no description) |
U-4352 | (no description) |
U-4347 | (no description) |
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the Komzifti drug page →
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This patent protects methods and compositions for inhibiting the interaction of menin with certain proteins, useful for treating various diseases.USPTO title: Methods and compositions for inhibiting the interaction of menin with MLL proteins
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This patent protects methods and compositions for inhibiting the interaction of menin with certain proteins to treat various diseases.USPTO title: Methods and compositions for inhibiting the interaction of menin with MLL proteins
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USPTO title: Targeting chromatin regulators inhibits leukemogenic gene expression in NPM1 mutant leukemia
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This patent protects methods of using specific compositions to inhibit the interaction of menin with certain proteins, useful for treating various diseases.USPTO title: Substituted inhibitors of menin-MLL and methods of use
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This patent protects compounds that inhibit the interaction between menin and certain proteins, and methods for treating diseases dependent on these proteins.USPTO title: Substituted inhibitors of menin-MLL and methods of use
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This patent protects methods for treating hematological malignancies and Ewing's sarcoma using menin inhibitors.USPTO title: Methods for treating hematological malignancies and Ewing's sarcoma
Sources
- FDA Orange Book — patents listed against Komzifti (NDA filed 2025)
- Komzifti drug profile — full patent estate, indications, clinical trials, pricing
- Kura patent portfolio
- Patent cliff 2036 — 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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