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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 Akorn, Diagnostic Green, and Novadaq Tech, and is included in three NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Indocyanine green has eighty-five patent family members in sixteen countries.
There are three drug master file entries for indocyanine green. Four suppliers are listed for this compound.
Summary for indocyanine green
| International Patents: | 85 |
| US Patents: | 8 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 3 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 170 |
| Patent Applications: | 6,326 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for indocyanine green |
| What excipients (inactive ingredients) are in indocyanine green? | indocyanine green excipients list |
| DailyMed Link: | indocyanine green at DailyMed |
Recent Clinical Trials for indocyanine green
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Massachusetts General Hospital | Phase 2 |
| University of Pennsylvania | Phase 1/Phase 2 |
| Stryker Nordic | Phase 2 |
Medical Subject Heading (MeSH) Categories for indocyanine green
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 | Start Trial | Start Trial | Start Trial | ||||
| Novadaq Tech | SPY AGENT GREEN KIT | indocyanine green | POWDER;INTRAVENOUS, INTERSTITIAL | 211580-001 | Nov 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novadaq Tech | SPY AGENT GREEN KIT | indocyanine green | POWDER;INTRAVENOUS, INTERSTITIAL | 211580-001 | Nov 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for indocyanine green
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20190022940 | Start Trial |
| Japan | 5476317 | Start Trial |
| Denmark | 1143852 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
