Versed generics — when can they launch?
Versed (midazolam) · Generic (originally Roche) · 6 active US patents · 0 expired
Where Versed sits in the generic timeline
Imminent generic cliff: earliest active US patent for Versed expires in 2028 (~2 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.
- Formulation — 3 patents
- Method of Use — 3 patents
FDA U-codes carved out by Versed 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-2526 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Versed drug page →
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This patent protects a liquid pharmaceutical composition containing a therapeutic agent and an alkoxy-polyethylene glycol for administration to a mammal.USPTO title: Methods and compositions for the delivery of a therapeutic agent
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This patent protects methods and systems for delivering a therapeutic agent, such as Versed, using a liquid pharmaceutical composition with an alkoxy-polyethylene glycol.USPTO title: Methods and systems for the delivery of a therapeutic agent
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This patent protects methods and compositions for delivering a therapeutic agent, such as Versed, to a mammal using a liquid pharmaceutical composition.USPTO title: Methods and compositions for the delivery of a therapeutic agent
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This patent protects methods and compositions for delivering a therapeutic agent, such as Versed, to a mammal using a liquid pharmaceutical composition.USPTO title: Methods and compositions for the delivery of a therapeutic agent
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This patent protects a preservative-free aqueous midazolam solution packaged in flexible plastic containers.USPTO title: Midazolam in flexible bags
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This patent protects a preservative-free aqueous midazolam solution packaged in flexible plastic containers.USPTO title: Midazolam in flexible bags
Sources
- FDA Orange Book — patents listed against Versed (NDA filed 1985)
- Versed drug profile — full patent estate, indications, clinical trials, pricing
- Generic (originally Roche) patent portfolio
- Patent cliff 2028 — 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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