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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202207


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NDA 202207 describes LYMPHOSEEK KIT, which is a drug marketed by Cardinal Health 414 and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LYMPHOSEEK KIT profile page.

The generic ingredient in LYMPHOSEEK KIT is technetium tc-99m tilmanocept. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m tilmanocept profile page.
Summary for 202207
Tradename:LYMPHOSEEK KIT
Applicant:Cardinal Health 414
Ingredient:technetium tc-99m tilmanocept
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202207
Generic Entry Date for 202207*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INJECTION

*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: 202207
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYMPHOSEEK KIT technetium tc-99m tilmanocept INJECTABLE;INJECTION 202207 NDA Cardinal Health 414, LLC 65857-425 65857-425-05 1 KIT in 1 CARTON (65857-425-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01)
LYMPHOSEEK KIT technetium tc-99m tilmanocept INJECTABLE;INJECTION 202207 NDA Cardinal Health 414, LLC 65857-450 65857-450-05 1 KIT in 1 CARTON (65857-450-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) * 1 INJECTION, SOLUTION in 1 VIAL (65857-401-45)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Mar 13, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:May 19, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Try a TrialPatent Expiration:May 12, 2025Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Jan 30, 2029Product Flag?YSubstance Flag?Delist Request?

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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.