Imbruvica generics — when can they launch?
Imbruvica (ibrutinib) · AbbVie · 448 active US patents · 0 expired
Where Imbruvica sits in the generic timeline
Imminent generic cliff: earliest active US patent for Imbruvica expires in 2026 (~1 year 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.
- Other — 212 patents
- Method of Use — 123 patents
- Composition of Matter — 70 patents
- Formulation — 43 patents
FDA U-codes carved out by Imbruvica 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-2242 | (no description) |
U-1491 | (no description) |
U-2241 | (no description) |
U-1650 | (no description) |
U-1946 | (no description) |
U-2666 | (no description) |
U-3422 | (no description) |
U-1456 | (no description) |
U-3843 | (no description) |
U-2219 | (no description) |
U-3844 | (no description) |
U-2228 | (no description) |
U-2159 | (no description) |
U-2243 | (no description) |
U-2944 | (no description) |
U-3846 | (no description) |
U-2943 | (no description) |
U-1684 | (no description) |
U-2665 | (no description) |
U-3845 | (no description) |
Sample patent estate
Showing 6 of 448 active US patents. View full estate on the Imbruvica drug page →
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This patent protects compounds that form covalent bonds with Bruton's tyrosine kinase (Btk) and methods for their preparation and use in treating various diseases.USPTO title: Inhibitors of Bruton's tyrosine kinase
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This patent protects compounds that form covalent bonds with Bruton's tyrosine kinase (Btk) and their methods of preparation and use in treating various diseases.USPTO title: Inhibitors of bruton's tyrosine kinase
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This patent protects compounds that inhibit Bruton's tyrosine kinase (Btk) and methods for their preparation and use in treating various diseases.USPTO title: Inhibitors of bruton'S tyrosine kinase
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This patent protects compounds that inhibit Bruton's tyrosine kinase (Btk) and methods for their preparation and use in treating various diseases.USPTO title: Inhibitors of bruton'S tyrosine kinase
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This patent protects methods of using certain compounds that inhibit Bruton's tyrosine kinase for treating various diseases and conditions.USPTO title: Inhibitors of Bruton's tyrosine kinase
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This patent protects methods of using certain compounds that inhibit Bruton's tyrosine kinase for treating various diseases and conditions.USPTO title: Inhibitors of Bruton's tyrosine kinase
Sources
- FDA Orange Book — patents listed against Imbruvica (NDA filed 2013)
- Imbruvica drug profile — full patent estate, indications, clinical trials, pricing
- AbbVie patent portfolio
- Patent cliff 2026 — 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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