Details for New Drug Application (NDA): 214511
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NDA 214511 describes LUMISIGHT, which is a drug marketed by Lumicell and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the LUMISIGHT profile page.
The generic ingredient in LUMISIGHT is pegulicianine acetate. One supplier is listed for this compound. Additional details are available on the pegulicianine acetate profile page.
The generic ingredient in LUMISIGHT is pegulicianine acetate. One supplier is listed for this compound. Additional details are available on the pegulicianine acetate profile page.
Summary for 214511
| Tradename: | LUMISIGHT |
| Applicant: | Lumicell |
| Ingredient: | pegulicianine acetate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214511
Generic Entry Date for 214511*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 214511
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUMISIGHT | pegulicianine acetate | POWDER;INTRAVENOUS | 214511 | NDA | Lumicell, Inc. | 82292-040 | 82292-040-10 | 10 VIAL in 1 CARTON (82292-040-10) / 3.9 mL in 1 VIAL (82292-040-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
| Approval Date: | Apr 17, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 17, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD COMPRISING ADMINISTERING PEGULICIANINE TO A HUMAN AND OBTAINING AN IMAGE OF A TUMOR BED AFTER TUMOR RESECTION TO DISTINGUISH IN SITU CANCER CELLS FROM HEALTHY CELLS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD COMPRISING ADMINISTERING PEGULICIANINE TO A HUMAN AND OBTAINING AN IMAGE OF A TUMOR BED AFTER TUMOR RESECTION TO DISTINGUISH IN SITU CANCER CELLS FROM HEALTHY CELLS | ||||||||
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