Mektovi generics — when can they launch?
Mektovi (binimetinib) · Pfizer · 7 active US patents · 0 expired
Where Mektovi sits in the generic timeline
Imminent generic cliff: earliest active US patent for Mektovi expires in 2027 (~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 — 5 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by Mektovi 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-2333 | (no description) |
U-2331 | (no description) |
U-2332 | (no description) |
U-2330 | (no description) |
U-2334 | (no description) |
Sample patent estate
Showing 6 of 7 active US patents. View full estate on the Mektovi drug page →
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This patent protects a class of compounds, including Mektovi, that inhibit MEK and are useful in treating hyperproliferative diseases such as cancer and inflammation.USPTO title: N3 alkylated benzimidazole derivatives as MEK inhibitors
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This patent protects a novel class of compounds used to treat or prevent diseases associated with abnormal B-Raf activation.USPTO title: Compounds and compositions as protein kinase inhibitors
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This patent protects a novel class of compounds used to treat or prevent diseases associated with abnormal B-Raf activation.USPTO title: Compounds and compositions as protein kinase inhibitors
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This patent protects a novel class of compounds used to treat or prevent diseases associated with abnormal B-Raf activation.USPTO title: Compounds and compositions as protein kinase inhibitors
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This patent protects processes for preparing and pharmaceutical compositions of a specific MEK inhibitor, also known as Mektovi.USPTO title: Preparation of and formulation comprising a MEK inhibitor
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This patent protects processes for preparing and pharmaceutical compositions of a specific MEK inhibitor, identified as 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide.USPTO title: Preparation of and formulation comprising a MEK inhibitor
Sources
- FDA Orange Book — patents listed against Mektovi (NDA filed 2018)
- Mektovi drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer 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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