Decadron generics — when can they launch?
Decadron (dexamethasone) · Generic (originally Merck) · 15 active US patents · 0 expired
Where Decadron sits in the generic timeline
Imminent generic cliff: earliest active US patent for Decadron expires in 2027 (~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 — 10 patents
- Formulation — 5 patents
FDA U-codes carved out by Decadron 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-1082 | (no description) |
U-2487 | (no description) |
U-2340 | (no description) |
U-1680 | (no description) |
U-3344 | (no description) |
U-3418 | (no description) |
Sample patent estate
Showing 6 of 15 active US patents. View full estate on the Decadron drug page →
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This patent protects a type of eye drop composition that contains tobramycin and dexamethasone, a medication also known as Decadron.USPTO title: Topical ophthalmic compositions containing tobramycin and dexamethasone
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This patent protects a topical ophthalmic composition containing tobramycin and dexamethasone, specifically designed for longer ocular retention and improved suspension of dexamethasone.USPTO title: Topical ophthalmic compositions containing tobramycin and dexamethasone
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This patent protects a method of using a specific ophthalmic composition containing tobramycin and dexamethasone for enhanced ocular bioavailability.USPTO title: Topical ophthalmic compositions containing tobramycin and dexamethasone
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This patent protects a medical prosthesis that blocks or reduces tear flow through the eye and delivers a drug, such as Decadron, using a hydrogel plug.USPTO title: Drug delivery through hydrogel plugs
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This patent protects a medical prosthesis that blocks or reduces tear flow through the eye and delivers a drug, such as Decadron, using a hydrogel plug.USPTO title: Drug delivery through hydrogel plugs
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This patent protects devices that guide the loading and dispensing of accurate small doses of fluid from standard injection syringes.USPTO title: Dose guides for injection syringe
Sources
- FDA Orange Book — patents listed against Decadron (NDA filed 1958)
- Decadron drug profile — full patent estate, indications, clinical trials, pricing
- Generic (originally Merck) 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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