Ohtuvayre generics — when can they launch?
Ohtuvayre (ENSIFENTRINE) · Verona Pharma · 5 active US patents · 0 expired
Where Ohtuvayre sits in the generic timeline
Mid-term cliff: earliest active US patent for Ohtuvayre 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 — 3 patents
- Method of Use — 2 patents
FDA U-codes carved out by Ohtuvayre 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-3962 | (no description) |
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the Ohtuvayre drug page →
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This patent protects a specific crystalline form of a pyrimido[6,1-A] isoquinolin-4-one compound, also known as a polymorph of N-{2-[(2E)-2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]-isoquinolin-3(4H)-yl]ethyl}urea.USPTO title: Crystalline form of pyrimido[6,1-A] isoquinolin-4-one compound
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This patent protects a liquid inhalation formulation containing RPL554 or a pharmaceutically acceptable salt thereof.USPTO title: Liquid inhalation formulation comprising RPL554
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This patent protects a liquid inhalation formulation containing RPL554, a pharmaceutical composition suitable for administration by inhalation.USPTO title: Liquid inhalation formulation comprising RPL554
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This patent protects a process for producing a sterile liquid pharmaceutical composition suitable for inhalation that contains ensifentrine particles.USPTO title: Formulation production process
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This patent protects a particulate composition containing ensifentrine, a specific impurity, and another compound, used in liquid pharmaceutical compositions.USPTO title: Particulate composition
Sources
- FDA Orange Book — patents listed against Ohtuvayre (NDA filed 2024)
- Ohtuvayre drug profile — full patent estate, indications, clinical trials, pricing
- Verona Pharma 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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