Cytovene generics — when can they launch?
Cytovene (GANCICLOVIR) · Roche Palo · 1 active US patent · 0 expired
Where Cytovene sits in the generic timeline
Long-dated protection: earliest active US patent for Cytovene extends to 2034 (~8 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 1 patent
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the Cytovene drug page →
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This patent protects ready-to-use, substantially particulate-free, and stable ganciclovir formulations and methods for their manufacture and administration.USPTO title: Ganciclovir compositions and related methods
Sources
- FDA Orange Book — patents listed against Cytovene (NDA filed 1989)
- Cytovene drug profile — full patent estate, indications, clinical trials, pricing
- Roche Palo patent portfolio
- Patent cliff 2034 — 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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