Romvimza generics — when can they launch?
Romvimza (VIMSELTINIB) · Deciphera Pharms · 30 active US patents · 0 expired
Where Romvimza sits in the generic timeline
Long-dated protection: earliest active US patent for Romvimza 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 — 15 patents
- Formulation — 9 patents
- Composition of Matter — 6 patents
FDA U-codes carved out by Romvimza 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-4145 | (no description) |
Sample patent estate
Showing 6 of 30 active US patents. View full estate on the Romvimza drug page →
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Deciphera Pharmaceuticals LLC has patented compounds that inhibit c-FMS, c-KIT, and/or PDGFR kinases for treating cancer, autoimmune diseases, and metabolic bone disorders.USPTO title: 2-aminopyrimidin-6-ones and analogs exhibiting anti-cancer and anti-proliferative activities
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Deciphera Pharmaceuticals LLC has patented compounds that inhibit c-FMS, c-KIT, and/or PDGFR kinases for treating cancer, autoimmune diseases, and metabolic bone disorders.USPTO title: 2-aminopyrimidin-6-ones and analogs exhibiting anti-cancer and anti-proliferative activities
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Deciphera Pharmaceuticals LLC has patented compounds that inhibit c-FMS, c-KIT, and/or PDGFR kinases for treating cancer, autoimmune diseases, and metabolic bone disorders.USPTO title: 2-aminopyrimidin-6-ones and analogs exhibiting anti-cancer and anti-proliferative activities
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This patent protects methods of treating cancers and other tumors, including tenosynovial giant cell tumor, using CSFIR inhibitors.USPTO title: Methods of treating disorders using CSFIR inhibitors
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This patent protects methods of treating cancers and other tumors, including tenosynovial giant cell tumor, using CSF1R inhibitors.USPTO title: Methods of treating disorders using CSF1R inhibitors
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This patent protects methods of treating cancers and other tumors, including tenosynovial giant cell tumor, using CSF1R inhibitors.USPTO title: Methods of treating disorders using CSF1R inhibitors
Sources
- FDA Orange Book — patents listed against Romvimza (NDA filed 2025)
- Romvimza drug profile — full patent estate, indications, clinical trials, pricing
- Deciphera Pharms 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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