Veklury generics — when can they launch?
Veklury (remdesivir) · Gilead Sciences · 58 active US patents · 0 expired
Where Veklury sits in the generic timeline
Imminent generic cliff: earliest active US patent for Veklury 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.
- Other — 29 patents
- Composition of Matter — 14 patents
- Method of Use — 13 patents
- Formulation — 2 patents
FDA U-codes carved out by Veklury 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-3829 | (no description) |
U-3831 | (no description) |
U-3830 | (no description) |
U-3832 | (no description) |
U-3834 | (no description) |
U-3833 | (no description) |
U-3836 | (no description) |
U-3835 | (no description) |
Sample patent estate
Showing 6 of 58 active US patents. View full estate on the Veklury drug page →
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This patent protects a class of nucleoside compounds with a cyano group substitution at the 1' position, useful for treating Flaviviridae virus infections, particularly hepatitis C.USPTO title: 1â²substituted carba-nucleoside analogs for antiviral treatment
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This patent protects a class of nucleoside compounds with a cyano group substitution at the 1' position, useful for treating Flaviviridae virus infections, particularly hepatitis C.USPTO title: 1â²substituted carba-nucleoside analogs for antiviral treatment
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This patent protects the active drug substance of Veklury.
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This patent protects the active drug substance of Veklury.
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This patent protects novel nucleoside compounds and their derivatives for treating Flaviviridae virus infections, particularly hepatitis C.USPTO title: 1â²-substituted carba-nucleoside analogs for antiviral treatment
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This patent protects novel nucleoside compounds and their derivatives for treating Flaviviridae virus infections, particularly hepatitis C.USPTO title: 1â²-substituted carba-nucleoside analogs for antiviral treatment
Sources
- FDA Orange Book — patents listed against Veklury (NDA filed 2020)
- Veklury drug profile — full patent estate, indications, clinical trials, pricing
- Gilead Sciences 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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