METHOTREXATE SODIUM generics — when can they launch?
METHOTREXATE SODIUM (METHOTREXATE SODIUM) · · 7 active US patents · 0 expired
Where METHOTREXATE SODIUM sits in the generic timeline
Long-dated protection: earliest active US patent for METHOTREXATE SODIUM extends to 2033 (~7 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.
- Formulation — 5 patents
- Method of Use — 2 patents
FDA U-codes carved out by METHOTREXATE SODIUM 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-1349 | (no description) |
U-1699 | (no description) |
Sample patent estate
Showing 6 of 7 active US patents. View full estate on the METHOTREXATE SODIUM drug page →
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This patent protects a method of manufacturing a Methotrexate composition for oral administration by mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent.USPTO title: Methotrexate composition
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This patent protects a method of manufacturing a Methotrexate composition for oral administration by mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent.USPTO title: Methotrexate composition
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This patent protects a method of manufacturing a methotrexate composition for oral administration by mixing a methotrexate salt with an aqueous carrier agent.USPTO title: Methotrexate composition
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This patent protects a method of manufacturing a Methotrexate composition for oral administration by mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent.USPTO title: Methotrexate composition
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This patent protects a method of manufacturing a methotrexate composition for oral administration by mixing a methotrexate salt with an aqueous carrier agent.USPTO title: Methotrexate composition
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This patent protects a method of manufacturing a Methotrexate composition for oral administration by mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent.USPTO title: Methotrexate composition
Sources
- FDA Orange Book — patents listed against METHOTREXATE SODIUM (NDA filed 1953)
- METHOTREXATE SODIUM drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2033 — 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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