Kengreal generics — when can they launch?
Kengreal (CANGRELOR) · Chiesi · 7 active US patents · 0 expired
Where Kengreal sits in the generic timeline
Imminent generic cliff: earliest active US patent for Kengreal expires in 2029 (~3 years 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 — 4 patents
- Formulation — 3 patents
FDA U-codes carved out by Kengreal 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-2260 | (no description) |
U-1926 | (no description) |
U-2979 | (no description) |
Sample patent estate
Showing 6 of 7 active US patents. View full estate on the Kengreal drug page →
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This patent protects methods of treating or preventing stent thrombosis using pharmaceutical compositions containing cangrelor and optionally bivalirudin.USPTO title: Methods of treating or preventing stent thrombosis
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This patent protects methods of treating or preventing ischemic events in patients undergoing a specific medical procedure called percutaneous coronary intervention.USPTO title: Methods of treating, reducing the incidence of, and/or preventing ischemic events
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This patent protects methods of treating or preventing ischemic events in patients undergoing a specific medical procedure called percutaneous coronary intervention.USPTO title: Methods of treating, reducing the incidence of, and/or preventing ischemic events
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This patent protects pharmaceutical formulations containing high purity cangrelor, an active ingredient used to inhibit platelet activation and aggregation.USPTO title: Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
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This patent protects pharmaceutical formulations containing high purity cangrelor and methods for preparing and using them to inhibit platelet activation and aggregation.USPTO title: Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
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This patent protects pharmaceutical formulations containing high purity cangrelor, an active ingredient used to inhibit platelet activation and aggregation.USPTO title: Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Sources
- FDA Orange Book — patents listed against Kengreal (NDA filed 2015)
- Kengreal drug profile — full patent estate, indications, clinical trials, pricing
- Chiesi patent portfolio
- Patent cliff 2029 — 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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