Temovate generics — when can they launch?
Temovate (CLOBETASOL PROPIONATE) · Fougera Pharms · 8 active US patents · 0 expired
Where Temovate sits in the generic timeline
Imminent generic cliff: earliest active US patent for Temovate expires in 2028 (~2 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 — 6 patents
- Formulation — 2 patents
FDA U-codes carved out by Temovate 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-1410 | (no description) |
U-2771 | (no description) |
U-1858 | (no description) |
U-88 | (no description) |
U-19 | Combination therapy |
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the Temovate drug page →
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This patent protects a microemulsion composition for dermal delivery of a pharmaceutically active ingredient, including an occlusive agent and surfactants.USPTO title: Microemulsion process and composition
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This patent protects methods of using a topical formulation comprising a steroid for managing skin diseases or disorders such as psoriasis and dermatoses.USPTO title: Topical formulations comprising a steroid
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This patent protects topical compositions that include a corticosteroid, at least one alcohol, and a penetration-enhancing agent.USPTO title: Topical compositions comprising a corticosteroid
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This patent protects methods of using a topical formulation comprising a steroid for managing skin diseases or disorders such as psoriasis and dermatoses.USPTO title: Topical formulations comprising a steroid
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This patent protects formulations for the topical administration of steroids, specifically for managing skin diseases or disorders such as psoriasis and dermatoses.USPTO title: Topical formulations comprising a steroid
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This patent protects topical compositions that include a corticosteroid and a penetration-enhancing agent, without propylene glycol.USPTO title: Topical compositions comprising a corticosteroid
Sources
- FDA Orange Book — patents listed against Temovate (NDA filed 1985)
- Temovate drug profile — full patent estate, indications, clinical trials, pricing
- Fougera Pharms patent portfolio
- Patent cliff 2028 — 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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