Wayrilz generics — when can they launch?
Wayrilz (RILZABRUTINIB) · Genzyme Corp · 6 active US patents · 0 expired
Where Wayrilz sits in the generic timeline
Long-dated protection: earliest active US patent for Wayrilz extends to 2033 (~7 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 — 4 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by Wayrilz 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-4268 | (no description) |
U-4270 | (no description) |
U-4267 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Wayrilz drug page →
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This patent protects compounds with a specific structure, such as Formula (XI), and methods of using them to inhibit kinases.USPTO title: Kinase inhibitors
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This patent protects compounds that are tyrosine kinase inhibitors, specifically BTK inhibitors, and their pharmaceutical compositions for treating diseases such as cancer and arthritis.USPTO title: Substituted pyrazolo[3,4-d]pyrimidines as kinase inhibitors
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This patent protects compounds that inhibit tyrosine kinases, such as BTK, and are potentially useful for treating diseases like cancer and arthritis.USPTO title: Substituted pyrazolo[3,4-d]pyrimidines as kinase inhibitors
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This patent protects compounds that inhibit tyrosine kinases, such as BTK, and are potentially useful for treating diseases like cancer and arthritis.USPTO title: Pyrazolopyrimidine compounds as kinase inhibitors
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This patent protects methods for treating immune thrombocytopenia by administering the compound PRN1008 or its pharmaceutically acceptable salts.USPTO title: Methods for treating immune thrombocytopenia by administering (R)-2-[3-[4-amino-3-(2-fluoro-4-phenoxy-phenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidine-1-carbonyl]-4-methyl-4-[4-(oxetan-3-yl)piperazin-1-yl]pent-2-enenitrile
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This patent protects solid forms of a specific chemical compound and methods for making and using it to treat disorders and conditions mediated by BTK activity.USPTO title: Solid forms of 2-[3-[4-amino-3-(2-fluoro-4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidine-1-carbonyl]-4-methyl-4-[4-(oxetan-3-yl)piperazin-1-yl]pent-2-enenitrile
Sources
- FDA Orange Book — patents listed against Wayrilz (NDA filed 2025)
- Wayrilz drug profile — full patent estate, indications, clinical trials, pricing
- Genzyme Corp patent portfolio
- Patent cliff 2033 — 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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