Diprolene generics — when can they launch?
Diprolene (BETAMETHASONE DIPROPIONATE) · Merck & Co. · 20 active US patents · 0 expired
Where Diprolene sits in the generic timeline
Imminent generic cliff: earliest active US patent for Diprolene 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.
- Method of Use — 11 patents
- Formulation — 7 patents
- Other — 2 patents
FDA U-codes carved out by Diprolene 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-1858 | (no description) |
U-2627 | (no description) |
U-1761 | (no description) |
U-1408 | (no description) |
Sample patent estate
Showing 6 of 20 active US patents. View full estate on the Diprolene drug page →
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This patent protects a topical composition containing a polyaphron dispersion, vitamin D or a vitamin D analog, and a corticosteroid.USPTO title: Topical 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 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 in propellant-free, non-foaming, and alcohol-free sprays for managing skin diseases or disorders.USPTO title: Topical formulations comprising a steroid
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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 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
Sources
- FDA Orange Book — patents listed against Diprolene (NDA filed 1975)
- Diprolene drug profile — full patent estate, indications, clinical trials, pricing
- Merck & Co. 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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