Benzamycin generics — when can they launch?
Benzamycin (BENZOYL PEROXIDE) · Mayne Pharma · 38 active US patents · 0 expired
Where Benzamycin sits in the generic timeline
Imminent generic cliff: earliest active US patent for Benzamycin 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 — 31 patents
- Formulation — 7 patents
FDA U-codes carved out by Benzamycin 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-3194 | (no description) |
U-3356 | (no description) |
U-124 | (no description) |
U-916 | (no description) |
U-134 | (no description) |
U-818 | (no description) |
U-3987 | (no description) |
U-3357 | (no description) |
U-3947 | (no description) |
Sample patent estate
Showing 6 of 38 active US patents. View full estate on the Benzamycin drug page →
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This patent protects a method for coating solid particles with a metal oxide layer.USPTO title: Method for preparing particles comprising metal oxide coating and particles with metal oxide coating
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This patent protects a method for coating solid particles with a metal oxide layer.USPTO title: Method for preparing particles comprising metal oxide coating and particles with metal oxide coating
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This patent protects a method for coating solid particles with a metal oxide layer.USPTO title: Method for preparing particles comprising metal oxide coating and particles with metal oxide coating
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This patent protects a composition for topical application that combines a peroxide and a retinoid, with one of the ingredients coated with a metal oxide layer.USPTO title: Compositions for topical application comprising a peroxide and retinoid
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This patent protects a process for coating solid, water-insoluble particulate matter with a metal oxide layer.USPTO title: Metal oxide coating of water insoluble ingredients
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This patent protects a process for coating solid, water-insoluble particulate matter with a metal oxide layer.USPTO title: Metal oxide coating of water insoluble ingredients
Sources
- FDA Orange Book — patents listed against Benzamycin (NDA filed 1984)
- Benzamycin drug profile — full patent estate, indications, clinical trials, pricing
- Mayne Pharma 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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