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Last Updated: October 31, 2024

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.
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:RXDosage:POWDER;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Apr 17, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 17, 2029
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Dec 8, 2031Product 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 UpPatent Expiration:Dec 8, 2031Product 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.