Cutivate generics — when can they launch?
Cutivate (FLUTICASONE PROPIONATE) · Teva Pharm · 118 active US patents · 2 expired
Where Cutivate sits in the generic timeline
All listed Orange Book patents for Cutivate 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.
- Other — 59 patents
- Formulation — 49 patents
- Method of Use — 10 patents
FDA U-codes carved out by Cutivate 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-2133 | (no description) |
U-645 | (no description) |
Sample patent estate
Showing 6 of 118 active US patents. View full estate on the Cutivate drug page →
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This patent protects an actuation indicator for a dispensing device that includes a rotatable wheel and a ratchet pawl mechanism.USPTO title: Actuation indicator for a dispensing device
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This patent protects an actuation indicator for a dispensing device that includes a rotatable wheel and a ratchet pawl mechanism.USPTO title: Actuation indicator for a dispensing device
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This patent protects an airflow adaptor for a breath-actuated dry powder inhaler that allows air to flow independently of a conduit.USPTO title: Airflow adaptor for a breath-actuated dry powder inhaler
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This patent protects an airflow adaptor for a breath-actuated dry powder inhaler that allows air to flow independently of a conduit.USPTO title: Airflow adaptor for a breath-actuated dry powder inhaler
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This patent protects an airflow adaptor for a breath-actuated dry powder inhaler that allows air to flow independently of a conduit.USPTO title: Airflow adaptor for a breath-actuated dry powder inhaler
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This patent protects an airflow adaptor for a breath-actuated dry powder inhaler that allows air to flow independently of a conduit.USPTO title: Airflow adaptor for a breath-actuated dry powder inhaler
Sources
- FDA Orange Book — patents listed against Cutivate (NDA filed 1990)
- Cutivate drug profile — full patent estate, indications, clinical trials, pricing
- Teva Pharm 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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