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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 205598


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NDA 205598 describes MACRILEN, which is a drug marketed by Novo and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the MACRILEN profile page.

The generic ingredient in MACRILEN is macimorelin acetate. One supplier is listed for this compound. Additional details are available on the macimorelin acetate profile page.
Summary for 205598
Tradename:MACRILEN
Applicant:Novo
Ingredient:macimorelin acetate
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205598
Generic Entry Date for 205598*:
Constraining patent/regulatory exclusivity:
FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)
Dosage:
FOR SOLUTION;ORAL

*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: 205598
Suppliers and Packaging for NDA: 205598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MACRILEN macimorelin acetate FOR SOLUTION;ORAL 205598 NDA Novo Nordisk 0169-1401 0169-1401-01 1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrengthEQ 60MG BASE/POUCH
Approval Date:Dec 20, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 20, 2024
Regulatory Exclusivity Use:FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)
Patent:⤷  Try a TrialPatent Expiration:Oct 12, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN

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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.