Kalydeco generics — when can they launch?
Kalydeco (IVACAFTOR) · Vertex Pharms Inc · 425 active US patents · 0 expired
Where Kalydeco sits in the generic timeline
All listed Orange Book patents for Kalydeco have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 187 patents
- Method of Use — 153 patents
- Formulation — 45 patents
- Composition of Matter — 40 patents
FDA U-codes carved out by Kalydeco 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-3021 | (no description) |
U-3608 | (no description) |
U-1905 | (no description) |
U-1311 | (no description) |
U-2374 | (no description) |
U-3424 | (no description) |
U-1973 | (no description) |
U-1909 | (no description) |
U-2530 | (no description) |
U-2376 | (no description) |
U-2276 | (no description) |
U-2246 | (no description) |
U-1911 | (no description) |
U-2575 | (no description) |
U-3429 | (no description) |
U-3606 | (no description) |
U-2569 | (no description) |
U-2573 | (no description) |
U-2512 | (no description) |
U-2343 | (no description) |
Sample patent estate
Showing 6 of 425 active US patents. View full estate on the Kalydeco drug page →
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This patent protects modulators of ATP-Binding Cassette transporters, including methods of treating diseases mediated by these transporters.USPTO title: Modulators of ATP-binding cassette transporters
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This patent protects modulators of ATP-Binding Cassette transporters, including methods of treating diseases mediated by these transporters.USPTO title: Modulators of ATP-binding cassette transporters
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This patent protects modulators of ATP-Binding Cassette transporters, including methods of treating diseases mediated by these transporters.USPTO title: Modulators of ATP-binding cassette transporters
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This patent protects modulators of ATP-Binding Cassette transporters, including methods of treating diseases mediated by these transporters.USPTO title: Modulators of ATP-binding cassette transporters
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This patent protects modulators of ATP-Binding Cassette transporters, including methods of treating diseases mediated by these transporters.USPTO title: Modulators of ATP-binding cassette transporters
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This patent protects modulators of ATP-Binding Cassette transporters, including methods of treating diseases mediated by these transporters.USPTO title: Modulators of ATP-binding cassette transporters
Sources
- FDA Orange Book — patents listed against Kalydeco (NDA filed 2012)
- Kalydeco drug profile — full patent estate, indications, clinical trials, pricing
- Vertex Pharms Inc 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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