Caduet generics — when can they launch?
Caduet (Amlodipine Besylate) · Pfizer Inc. · 16 active US patents · 0 expired
Where Caduet sits in the generic timeline
Imminent generic cliff: earliest active US patent for Caduet 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 — 10 patents
- Formulation — 6 patents
FDA U-codes carved out by Caduet 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-3 | Treatment of inflammatory conditions |
U-3448 | (no description) |
U-3309 | (no description) |
U-3311 | (no description) |
Sample patent estate
Showing 6 of 16 active US patents. View full estate on the Caduet drug page →
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This patent protects a specific crystalline form of perindopril arginine, a process for its preparation, and pharmaceutical compositions containing it.USPTO title: α crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it
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This patent protects a specific crystalline form of perindopril arginine, a process for its preparation, and pharmaceutical compositions containing it.USPTO title: α crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it
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This patent protects a specific crystalline form of perindopril arginine, a process for its preparation, and pharmaceutical compositions containing it.USPTO title: α crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it
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This patent protects pharmaceutical compositions that combine an angiotensin II receptor blocker, a diuretic, and a calcium channel blocker for treating hypertension.USPTO title: Compositions for the treatment of hypertension
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This patent protects pharmaceutical compositions for treating hypertension that combine an angiotensin II receptor blocker, a diuretic, and a calcium channel blocker.USPTO title: Compositions for the treatment of hypertension
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This patent protects pharmaceutical compositions that combine an angiotensin II receptor blocker, a diuretic, and a calcium channel blocker for treating hypertension.USPTO title: Compositions for the treatment of hypertension
Sources
- FDA Orange Book — patents listed against Caduet (NDA)
- Caduet drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer Inc. 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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