Spy Agent Green Kit generics — when can they launch?
Spy Agent Green Kit (INDOCYANINE GREEN) · Renew Pharms · 5 active US patents · 0 expired
Where Spy Agent Green Kit sits in the generic timeline
Imminent generic cliff: earliest active US patent for Spy Agent Green Kit 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.
- Method of Use — 4 patents
- Formulation — 1 patent
FDA U-codes carved out by Spy Agent Green Kit 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-2462 | (no description) |
U-2468 | (no description) |
U-2463 | (no description) |
U-2815 | (no description) |
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the Spy Agent Green Kit drug page →
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This patent protects methods and systems for neurovascular imaging.USPTO title: Method and apparatus for vasculature visualization with applications in neurosurgery and neurology
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This patent protects methods and systems for imaging vessels in a subject, particularly in relation to solid organ transplants.USPTO title: Real time imaging during solid organ transplant
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This patent protects a method for evaluating the amount of blood flow in heart tissue by analyzing fluorescence signals from images.USPTO title: Method for evaluating blush in myocardial tissue
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This patent protects a method and apparatus for measuring changes in blood flow in tissue using a fluorescence agent and photoplethysmography.USPTO title: Quantification of absolute blood flow in tissue using fluorescence-mediated photoplethysmography
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This patent protects a surgical system that automatically enhances video images of a surgical site and controls recording based on certain conditions or events.USPTO title: Methods and systems to automate surgical interventions
Sources
- FDA Orange Book — patents listed against Spy Agent Green Kit (NDA filed 1959)
- Spy Agent Green Kit drug profile — full patent estate, indications, clinical trials, pricing
- Renew Pharms 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.
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