URIDINE TRIACETATE generics — when can they launch?
URIDINE TRIACETATE (URIDINE TRIACETATE) · · 1 active US patent · 0 expired
Where URIDINE TRIACETATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for URIDINE TRIACETATE expires in 2027 (~1 year 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.
- Method of Use — 1 patent
FDA U-codes carved out by URIDINE TRIACETATE 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-1791 | (no description) |
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the URIDINE TRIACETATE drug page →
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This patent protects methods for treating and preventing toxicity caused by chemotherapeutic and antiviral agents using acylated pyrimidine nucleosides.USPTO title: Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
Sources
- FDA Orange Book — patents listed against URIDINE TRIACETATE (NDA filed 2015)
- URIDINE TRIACETATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — 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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