Zokinvy generics — when can they launch?
Zokinvy (LONAFARNIB) · Sentynl Theraps Inc · 2 active US patents · 0 expired
Where Zokinvy sits in the generic timeline
Imminent generic cliff: earliest active US patent for Zokinvy 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.
- Method of Use — 2 patents
FDA U-codes carved out by Zokinvy 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-3070 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Zokinvy drug page →
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This patent protects the use of farnesyltransferase inhibitors for treating laminopathies, cellular aging, and atherosclerosis.USPTO title: Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis
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This patent protects the use of farnesyltransferase inhibitors for treating laminopathies, cellular aging, and atherosclerosis.USPTO title: Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis
Sources
- FDA Orange Book — patents listed against Zokinvy (NDA filed 2020)
- Zokinvy drug profile — full patent estate, indications, clinical trials, pricing
- Sentynl Theraps Inc 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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