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Last Updated: March 28, 2024

INDOCYANINE GREEN - Generic Drug Details


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What are the generic drug sources for indocyanine green and what is the scope of patent protection?

Indocyanine green is the generic ingredient in three branded drugs marketed by Renew Pharms and Novadaq Tech, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indocyanine green has fifty-five patent family members in eleven countries.

There are three drug master file entries for indocyanine green. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for INDOCYANINE GREEN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Center, ChinaN/A
OnLume Inc.Early Phase 1
University of Wisconsin, MadisonEarly Phase 1

See all INDOCYANINE GREEN clinical trials

Generic filers with tentative approvals for INDOCYANINE GREEN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a Trial10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a Trial50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for INDOCYANINE GREEN
Paragraph IV (Patent) Challenges for INDOCYANINE GREEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPY AGENT GREEN KIT For Injection indocyanine green 25 mg/vial 211580 1 2022-11-28

US Patents and Regulatory Information for INDOCYANINE GREEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Renew Pharms IC-GREEN indocyanine green INJECTABLE;INJECTION 011525-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Renew Pharms IC-GREEN indocyanine green INJECTABLE;INJECTION 011525-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Renew Pharms INDOCYANINE GREEN indocyanine green INJECTABLE;INJECTION 040811-001 Nov 21, 2007 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for INDOCYANINE GREEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 ⤷  Try a Trial ⤷  Try a Trial
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 ⤷  Try a Trial ⤷  Try a Trial
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for INDOCYANINE GREEN

Country Patent Number Title Estimated Expiration
China 102083362 Locating and analyzing perforator flaps for plastic and reconstructive surgery ⤷  Try a Trial
Japan 2011509768 ⤷  Try a Trial
European Patent Office 3599981 PROCÉDÉS ET SYSTÈMES POUR AUTOMATISER DES INTERVENTIONS CHIRURGICALES (METHODS AND SYSTEMS TO AUTOMATE SURGICAL INTERVENTIONS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009092162 ⤷  Try a Trial
Japan 5918532 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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