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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211488


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NDA 211488 describes CAMCEVI KIT, which is a drug marketed by Accord and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the CAMCEVI KIT profile page.

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the leuprolide mesylate profile page.
Summary for 211488
Tradename:CAMCEVI KIT
Applicant:Accord
Ingredient:leuprolide mesylate
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211488
Generic Entry Date for 211488*:
Constraining patent/regulatory exclusivity:
Dosage:
EMULSION;SUBCUTANEOUS

*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.

Pharmacology for NDA: 211488
Suppliers and Packaging for NDA: 211488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488 NDA Accord BioPharma, Inc. 69448-014 69448-014-63 1 SYRINGE in 1 CARTON (69448-014-63) / .37 g in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;SUBCUTANEOUSStrengthEQ 42MG BASE
Approval Date:May 25, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:May 25, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jan 16, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 1, 2039Product 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.