Synribo generics — when can they launch?
Synribo (OMACETAXINE MEPESUCCINATE) · Teva Pharms Intl · 1 active US patent · 0 expired
Where Synribo sits in the generic timeline
All listed Orange Book patents for Synribo have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 Synribo 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-1300 | (no description) |
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the Synribo drug page →
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This patent protects a method of treating chronic myelogenous leukemia in subjects resistant or intolerant to STI571 by administering homoharringtonine.USPTO title: Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents
Sources
- FDA Orange Book — patents listed against Synribo (NDA filed 2012)
- Synribo drug profile — full patent estate, indications, clinical trials, pricing
- Teva Pharms Intl patent portfolio
- Patent cliff 2026 — 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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