Altace generics — when can they launch?
Altace (RAMIPRIL) · King Pfizer · 1 active US patent · 0 expired
Where Altace sits in the generic timeline
Long-dated protection: earliest active US patent for Altace extends to 2039 (~13 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 1 patent
FDA U-codes carved out by Altace 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-4233 | (no description) |
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the Altace drug page →
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This patent protects a pharmaceutical composition in the form of a solution for oral delivery that includes ramipril as the active pharmaceutical ingredient.USPTO title: Ramipril solution for oral dosage
Sources
- FDA Orange Book — patents listed against Altace (NDA filed 1991)
- Altace drug profile — full patent estate, indications, clinical trials, pricing
- King Pfizer patent portfolio
- Patent cliff 2039 — 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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