Microzide generics — when can they launch?
Microzide (hydrochlorothiazide) · Generic (originally Merck) · 1 active US patent · 0 expired
Where Microzide sits in the generic timeline
Long-dated protection: earliest active US patent for Microzide extends to 2044 (~18 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 1 patent
FDA U-codes carved out by Microzide 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-4138 | (no description) |
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the Microzide drug page →
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This patent protects a highly pure hydrochlorothiazide powder for oral suspension and its reconstituted product for treating hypertension and edema.USPTO title: Hydrochlorothiazide compositions
Sources
- FDA Orange Book — patents listed against Microzide (NDA filed 1959)
- Microzide drug profile — full patent estate, indications, clinical trials, pricing
- Generic (originally Merck) patent portfolio
- Patent cliff 2044 — 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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