INDOCYANINE GREEN Drug Patent Profile
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Which patents cover Indocyanine Green, and what generic alternatives are available?
Indocyanine Green is a drug marketed by Renew Pharms and Zydus Lifesciences and is included in two NDAs.
The generic ingredient in INDOCYANINE GREEN is indocyanine green. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Indocyanine Green
A generic version of INDOCYANINE GREEN was approved as indocyanine green by RENEW PHARMS on November 21st, 2007.
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Summary for INDOCYANINE GREEN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 256 |
| Patent Applications: | 7,127 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INDOCYANINE GREEN |
| DailyMed Link: | INDOCYANINE GREEN at DailyMed |
Recent Clinical Trials for INDOCYANINE GREEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nada Mahmoud Soliman | PHASE2 |
| Medical University of South Carolina | PHASE2 |
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | PHASE4 |
Medical Subject Heading (MeSH) Categories for INDOCYANINE GREEN
Anatomical Therapeutic Chemical (ATC) Classes 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
INDOCYANINE GREEN is protected by zero US patents and one FDA Regulatory Exclusivity.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Renew Pharms | INDOCYANINE GREEN | indocyanine green | INJECTABLE;INJECTION | 040811-001 | Nov 21, 2007 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zydus Lifesciences | INDOCYANINE GREEN | indocyanine green | INJECTABLE;INJECTION | 219139-001 | Aug 3, 2026 | AP | RX | No | No | ⤷ 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 |
