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.
Summary for INDOCYANINE GREEN
| International Patents: | 55 |
| US Patents: | 6 |
| Tradenames: | 3 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 211 |
| Patent Applications: | 7,182 |
| 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 |
|---|---|
| National Cancer Center, China | N/A |
| University of Wisconsin, Madison | Early Phase 1 |
| OnLume Inc. | Early Phase 1 |
Generic filers with tentative approvals for INDOCYANINE GREEN
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| ⤷ Try a Trial | ⤷ Try a Trial | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| ⤷ Try a Trial | ⤷ Try a Trial | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |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 | ||||
| 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 | ||||
| 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 | Y | ⤷ Try a Trial | |||
| Renew Pharms | IC-GREEN | indocyanine green | INJECTABLE;INJECTION | 011525-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 | Y | ⤷ 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 |
|---|---|---|---|
| Canada | 2811847 | LOCALISATION ET ANALYSE DE LAMBEAUX PERFORANTS POUR UNE CHIRURGIE PLASTIQUE ET RECONSTRUCTIVE (LOCATING AND ANALYZING PERFORATOR FLAPS FOR PLASTIC AND RECONSTRUCTIVE SURGERY) | ⤷ Try a Trial |
| Japan | 2013541370 | ⤷ Try a Trial | |
| South Korea | 101759850 | ⤷ Try a Trial | |
| Japan | 2017534361 | 蛍光媒介光電式容積脈波記録法を用いた組織中の絶対血流の定量化 | ⤷ Try a Trial |
| Mexico | 2010011249 | LOCALIZAR Y ANALIZAR ALETAS DE PERFORADOR PARA CIRUGIA PLASTICA Y RECONSTRUCTIVA. (LOCATING AND ANALYZING PERFORATOR FLAPS FOR PLASTIC AND RECONSTRUCTIVE SURGERY.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
