DIAZOXIDE CHOLINE generics — when can they launch?
DIAZOXIDE CHOLINE (DIAZOXIDE CHOLINE) · · 18 active US patents · 0 expired
Where DIAZOXIDE CHOLINE sits in the generic timeline
Imminent generic cliff: earliest active US patent for DIAZOXIDE CHOLINE expires in 2026 (~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 — 12 patents
- Composition of Matter — 6 patents
FDA U-codes carved out by DIAZOXIDE CHOLINE 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-4167 | (no description) |
U-4275 | (no description) |
U-4211 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the DIAZOXIDE CHOLINE drug page →
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This patent protects salts of potassium ATP channel openers, including diazoxide, and their pharmaceutical formulations and methods of administration.USPTO title: Salts of potassium ATP channel openers and uses thereof
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This patent protects salts of potassium ATP channel openers, including diazoxide, and their pharmaceutical formulations and methods of administration.USPTO title: Salts of potassium ATP channel openers and uses thereof
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This patent protects salts of potassium ATP channel openers, including diazoxide, and their pharmaceutical formulations and methods of administration.USPTO title: Salts of potassium ATP channel openers and uses thereof
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This patent protects salts of potassium ATP channel openers, such as diazoxide choline, and their pharmaceutical formulations and methods of administration.USPTO title: Salts of potassium ATP channel openers and uses thereof
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This patent protects salts of potassium ATP channel openers, such as diazoxide choline, and their pharmaceutical formulations and methods of administration.USPTO title: Salts of potassium ATP channel openers and uses thereof
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This patent protects salts of potassium ATP channel openers, such as diazoxide choline, and their pharmaceutical formulations and methods of administration.USPTO title: Salts of potassium ATP channel openers and uses thereof
Sources
- FDA Orange Book — patents listed against DIAZOXIDE CHOLINE (NDA)
- DIAZOXIDE CHOLINE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2026 — 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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