Mitozytrex generics — when can they launch?
Mitozytrex (MITOMYCIN) · Kyowa Kirin Co., Ltd. · 12 active US patents · 0 expired
Where Mitozytrex sits in the generic timeline
All listed Orange Book patents for Mitozytrex have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 7 patents
- Formulation — 5 patents
FDA U-codes carved out by Mitozytrex 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-2095 | (no description) |
U-4172 | (no description) |
U-4256 | (no description) |
Sample patent estate
Showing 6 of 12 active US patents. View full estate on the Mitozytrex drug page →
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This patent protects an apparatus for reconstituting a pharmaceutical, specifically an ophthalmic formulation of mitomycin-C, for transient application.USPTO title: Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
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This patent protects an apparatus and method for reconstituting a pharmaceutical, specifically an ophthalmic formulation of mitomycin-C, for transient application.USPTO title: Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
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This patent protects an apparatus and method for reconstituting a pharmaceutical, specifically an ophthalmic formulation of mitomycin-C, for transient application.USPTO title: Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
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This patent protects an apparatus for reconstituting a pharmaceutical, specifically an ophthalmic formulation of mitomycin-C, for transient application.USPTO title: Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
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This patent protects an apparatus and method for reconstituting a pharmaceutical, specifically an ophthalmic formulation of mitomycin-C, for transient application.USPTO title: Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
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This patent protects a hydrophilic biocompatible sustained-release material for injecting into internal body cavities to slowly release a therapeutic agent.USPTO title: Material and method for treating internal cavities
Sources
- FDA Orange Book — patents listed against Mitozytrex (NDA filed 1981)
- Mitozytrex drug profile — full patent estate, indications, clinical trials, pricing
- Kyowa Kirin Co., Ltd. patent portfolio
- 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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