Calquence generics — when can they launch?
Calquence (ACALABRUTINIB) · AstraZeneca · 9 active US patents · 0 expired
Where Calquence sits in the generic timeline
Imminent generic cliff: earliest active US patent for Calquence 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.
- Method of Use — 7 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by Calquence 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-4108 | (no description) |
U-2668 | (no description) |
U-3710 | (no description) |
U-2519 | (no description) |
U-4426 | (no description) |
U-2145 | (no description) |
U-2667 | (no description) |
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Calquence drug page →
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This patent protects compounds of a specific formula and their pharmaceutically acceptable salts, which inhibit the IGF-1R enzyme.USPTO title: Imidazopyrazine tyrosine kinase inhibitors
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This patent protects the use of 6-5 membered fused pyridine ring compounds in the treatment of Bruton's Tyrosine Kinase (Btk) mediated disorders.USPTO title: 4-imidazopyridazin-1-yl-benzamides as Btk inhibitors
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This patent protects 6-5 membered fused pyridine ring compounds according to formula (I) or a pharmaceutically acceptable salt thereof.USPTO title: 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors
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This patent protects the use of 6-5 membered fused pyridine ring compounds in the treatment of Bruton's Tyrosine Kinase (Btk) mediated disorders.USPTO title: 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
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This patent protects methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor.USPTO title: Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
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This patent protects methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor.USPTO title: Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Sources
- FDA Orange Book — patents listed against Calquence (NDA filed 2017)
- Calquence drug profile — full patent estate, indications, clinical trials, pricing
- AstraZeneca 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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