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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Teva
Chinese Patent Office
McKinsey
Farmers Insurance
Cerilliant
Healthtrust
Express Scripts
Harvard Business School
US Department of Justice

Generated: January 19, 2018

DrugPatentWatch Database Preview

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 two suppliers. 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. Two suppliers are 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
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 Navidea Biopharmaceuticals, Inc. 52579-1600 52579-1600-5 1 KIT in 1 CARTON (52579-1600-5) > 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (52579-1695-1) * 1 INJECTION, SOLUTION in 1 VIAL (52579-1649-1)
LYMPHOSEEK KIT technetium tc-99m tilmanocept INJECTABLE;INJECTION 202207 NDA Navidea Biopharmaceuticals, Inc. 52579-1604 52579-1604-5 1 KIT in 1 CARTON (52579-1604-5) > 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (52579-1695-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Mar 13, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 13, 2017
Regulatory Exclusivity Use:GUIDING SENTINEL LYMPH NODE BIOPSY, USING A HAND-HELD GAMMA COUNTER IN PATIENTS WITH CLINICALLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
Regulatory Exclusivity Expiration:Mar 13, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 13, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

US Army
McKesson
Teva
Federal Trade Commission
Boehringer Ingelheim
Fuji
Express Scripts
Johnson and Johnson
QuintilesIMS

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 verifification 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.

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