Generic entry timeline

Cleviprex generics — when can they launch?

Cleviprex (CLEVIDIPINE) · Chiesi · 9 active US patents · 0 expired

Earliest patent expiry

2031-10-10

5 years remaining

Full patent estate to

2031-10-10

complete protection through 2031

FDA approval

2008

Chiesi

Where Cleviprex sits in the generic timeline

Mid-term cliff: earliest active US patent for Cleviprex expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.

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.

Formulation — 9 patents

Sample patent estate

Showing 6 of 9 active US patents. View full estate on the Cleviprex drug page →

US11103490 Formulation · expires 2031-10-10

This patent protects formulations of clevidipine in an oil-in-water emulsion that resist microbial growth and are stable against impurities.

USPTO title: Clevidipine emulsion formulations containing antimicrobial agents
US10010537 Formulation · expires 2031-10-10

This patent protects formulations of clevidipine, specifically Cleviprex, that contain antimicrobial agents to reduce microbial growth.

USPTO title: Clevidipine emulsion formulations containing antimicrobial agents
US10010537 Formulation · expires 2031-10-10

This patent protects formulations of clevidipine, specifically Cleviprex, that contain antimicrobial agents to reduce microbial growth.

USPTO title: Clevidipine emulsion formulations containing antimicrobial agents
US8658676 Formulation · expires 2031-10-10

This patent protects formulations of clevidipine, specifically an oil-in-water emulsion, that are resistant to microbial growth and stable against impurities.

USPTO title: Clevidipine emulsion formulations containing antimicrobial agents
US8658676 Formulation · expires 2031-10-10

This patent protects formulations of clevidipine, specifically an oil-in-water emulsion, that resist microbial growth and are stable against impurities.

USPTO title: Clevidipine emulsion formulations containing antimicrobial agents
US10010537 Formulation · expires 2031-10-10

This patent protects formulations of clevidipine, specifically Cleviprex, that contain antimicrobial agents to reduce microbial growth.

USPTO title: Clevidipine emulsion formulations containing antimicrobial agents

Sources

FDA Orange Book — patents listed against Cleviprex (NDA filed 2008)
Cleviprex drug profile — full patent estate, indications, clinical trials, pricing
Chiesi patent portfolio
Patent cliff 2031 — 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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