Deltasone generics — when can they launch?
Deltasone (prednisone) · Generic (originally Schering) · 4 active US patents · 0 expired
Where Deltasone sits in the generic timeline
Imminent generic cliff: earliest active US patent for Deltasone 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 — 4 patents
FDA U-codes carved out by Deltasone 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-1362 | (no description) |
U-1269 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Deltasone drug page →
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This patent protects a delayed-release dosage form of a glucocorticoid for treating rheumatic disease and/or osteoarthritis.USPTO title: Delayed-release glucocorticoid treatment of rheumatoid disease
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This patent protects a delayed-release dosage form of a glucocorticoid for treating rheumatic disease and/or osteoarthritis.USPTO title: Delayed-release glucocorticoid treatment of rheumatoid disease
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This patent protects a delayed-release dosage form of a glucocorticoid for treating rheumatic disease and/or osteoarthritis.USPTO title: Delayed-release glucocorticoid treatment of rheumatoid disease
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This patent protects a press-coated tablet with a core containing a drug substance, designed to release the substance with a lag time of 2-6 hours.USPTO title: Delayed release tablet with defined core geometry
Sources
- FDA Orange Book — patents listed against Deltasone (NDA filed 1955)
- Deltasone drug profile — full patent estate, indications, clinical trials, pricing
- Generic (originally Schering) 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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