Metro I.V. In Plastic Container generics — when can they launch?
Metro I.V. In Plastic Container (METRONIDAZOLE) · Baxter · 9 active US patents · 0 expired
Where Metro I.V. In Plastic Container sits in the generic timeline
Imminent generic cliff: earliest active US patent for Metro I.V. In Plastic Container expires in 2028 (~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.
- Formulation — 5 patents
- Method of Use — 4 patents
FDA U-codes carved out by Metro I.V. In Plastic Container 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-1682 | (no description) |
U-1664 | (no description) |
U-3169 | (no description) |
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Metro I.V. In Plastic Container drug page →
-
This patent protects compositions that increase the solubility of poorly soluble azole drug compounds, such as metronidazole, in water.USPTO title: Compositions for increasing solubility of azole drug compounds that are poorly soluble in water
-
This patent protects methods and compositions that increase the solubility of poorly soluble azole drug compounds, such as metronidazole, in water.USPTO title: Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water
-
This patent protects methods and compositions that increase the solubility of poorly soluble azole drug compounds, such as metronidazole, in water.USPTO title: Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water
-
This patent protects high-dosage mucoadhesive metronidazole gel formulations for treating bacterial vaginosis through intravaginal application.USPTO title: High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis
-
This patent protects methods of treating bacterial vaginosis using mucoadhesive aqueous-based gel formulations of metronidazole.USPTO title: Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations
-
This patent protects mucoadhesive aqueous-based gel formulations of metronidazole for intravaginal application to treat bacterial vaginosis.USPTO title: Aqueous-based metronidazole gel formulations
Sources
- FDA Orange Book — patents listed against Metro I.V. In Plastic Container (NDA filed 1963)
- Metro I.V. In Plastic Container drug profile — full patent estate, indications, clinical trials, pricing
- Baxter patent portfolio
- Patent cliff 2028 — 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.
Get generic entry alerts
Free Pharma CI alerts on Metro I.V. In Plastic Container — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →