Toviaz generics — when can they launch?
Toviaz (Fesoterodine Fumarate) · Pfizer · 12 active US patents · 0 expired
Where Toviaz sits in the generic timeline
Imminent generic cliff: earliest active US patent for Toviaz 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.
- Other — 6 patents
- Method of Use — 4 patents
- Formulation — 2 patents
FDA U-codes carved out by Toviaz 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-913 | (no description) |
Sample patent estate
Showing 6 of 12 active US patents. View full estate on the Toviaz drug page →
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This patent protects a pharmaceutical granulate containing fesoterodine or a salt/solvate thereof, combined with a stabilizer such as xylitol or sorbitol.USPTO title: Pharmaceutical compositions comprising fesoterodine
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This patent protects a pharmaceutical granulate containing fesoterodine and a stabilizer, suitable for use in certain pharmaceutical compositions.USPTO title: Pharmaceutical compositions comprising fesoterodine
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This patent protects a pharmaceutical granulate containing fesoterodine and a stabilizer, suitable for use in certain pharmaceutical compositions.USPTO title: Pharmaceutical compositions comprising fesoterodine
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This patent protects a pharmaceutical granulate containing fesoterodine and a stabilizer, suitable for use in certain pharmaceutical compositions.USPTO title: Pharmaceutical compositions comprising fesoterodine
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This patent protects a pharmaceutical granulate containing fesoterodine and a stabilizer, suitable for use in certain pharmaceutical compositions.USPTO title: Pharmaceutical compositions comprising fesoterodine
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This patent protects a pharmaceutical granulate containing fesoterodine or a salt/solvate thereof, combined with a stabilizer such as xylitol or sorbitol.USPTO title: Pharmaceutical compositions comprising fesoterodine
Sources
- FDA Orange Book — patents listed against Toviaz (NDA filed 2008)
- Toviaz drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- 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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