Spy Agent Green Kit is a drug owned by Novadaq Technologies Ulc. It is protected by 9 US drug patents filed from 2018 to 2023. Out of these, 5 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 14, 2039. Details of Spy Agent Green Kit's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11712320 | Methods and systems to automate surgical interventions |
Jul, 2039
(12 years from now) | Active |
| US10631746 | Quantification of absolute blood flow in tissue using fluorescence-mediated photoplethysmography |
Aug, 2035
(8 years from now) | Active |
| US8406860 | Method for evaluating blush in myocardial tissue |
Apr, 2029
(2 years from now) | Active |
| US8647605 | Real time imaging during solid organ transplant |
Feb, 2029
(2 years from now) | Active |
| US8185176 | Method and apparatus for vasculature visualization with applications in neurosurgery and neurology |
Jun, 2028
(1 year, 7 months from now) | Active |
| US9421280 | Real time imaging during solid organ transplant |
Nov, 2025
(10 months ago) |
Expired
|
| US7881777 | Method and apparatus for performing intra-operative angiography |
Sep, 2021
(5 years ago) |
Expired
|
| US6915154 | Method and apparatus for performing intra-operative angiography |
Aug, 2021
(5 years ago) |
Expired
|
| US8892190 | Method and apparatus for performing intra-operative angiography |
Aug, 2020
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Spy Agent Green Kit's patents.
Latest Legal Activities on Spy Agent Green Kit's Patents
Given below is the list of recent legal activities going on the following patents of Spy Agent Green Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed | 29 Sep, 2025 | US8647605 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Sep, 2024 | US8406860 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Feb, 2024 | US9421280 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Nov, 2023 | US8185176 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Oct, 2023 | US10631746 |
| Mail Patent eGrant Notification | 01 Aug, 2023 | US11712320 |
| Recordation of Patent eGrant | 01 Aug, 2023 | US11712320 |
| Electronic Review
Critical | 01 Aug, 2023 | US11712320 |
| Patent eGrant Notification | 01 Aug, 2023 | US11712320 |
| Patent Issue Date Used in PTA Calculation
Critical | 01 Aug, 2023 | US11712320 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Spy Agent Green Kit and ongoing
litigations to
help you estimate the early arrival of Spy Agent Green Kit generic.
Spy Agent Green Kit's Litigations
Spy Agent Green Kit been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 22, 2017, against patent number US8892190. The petitioner Visionsense Corp., challenged the validity of this patent, with Novadaq Technologies Inc. as the respondent. Click below to track the latest information on how companies are challenging Spy Agent Green Kit's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8892190 | May, 2017 |
Terminated-Settled
(18 Apr, 2018) | Novadaq Technologies Inc. | Visionsense Corp. |
FDA has granted some exclusivities to Spy Agent Green Kit. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Spy Agent Green Kit,
regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying
the generic
launch. Given below are details of the exclusivities granted to
Spy Agent Green Kit.
Exclusivity Information
Spy Agent Green Kit holds 2 exclusivities. All of its exclusivities have expired in 2026. Details of Spy Agent Green Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 21, 2021 |
| New Indication(I-911) | Jun 05, 2026 |
US patents provide insights into the exclusivity only within the United States, but
Spy Agent Green Kit is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Spy Agent Green Kit's family patents as well as insights into
ongoing legal events
on those patents.
Spy Agent Green Kit's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Spy Agent Green Kit:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Spy Agent Green Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 14, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Spy Agent Green Kit Generic API suppliers:
Indocyanine Green is the generic name for the brand Spy Agent Green Kit. 2 different companies have already filed for the generic of Spy Agent Green Kit, with Renew Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Spy Agent Green Kit's generic
How can I launch a generic of Spy Agent Green Kit before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Spy Agent Green Kit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Spy Agent Green Kit's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Spy Agent Green Kit -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 28 Nov, 2022 | 04 Aug, 2035 | Extinguished | Less |
About Spy Agent Green Kit
Spy Agent Green Kit is a drug owned by Novadaq Technologies Ulc. It is used for visualizing blood flow in various surgical procedures and organ transplants. Spy Agent Green Kit uses Indocyanine Green as an active ingredient. Spy Agent Green Kit was launched by Novadaq Tech in 2018.
Approval Date:
Spy Agent Green Kit was approved by FDA for market use on 21 November, 2018.
Active Ingredient:
Spy Agent Green Kit uses Indocyanine Green as the active ingredient. Check out other Drugs and Companies using Indocyanine Green ingredient
Treatment:
Spy Agent Green Kit is used for visualizing blood flow in various surgical procedures and organ transplants.
Dosage:
Spy Agent Green Kit is available in powder form for intravenous, interstitial use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG/VIAL | POWDER | Prescription | INTRAVENOUS, INTERSTITIAL |