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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205598

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NDA 205598 describes MACRILEN, which is a drug marketed by Strongbridge Ireland 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 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:Strongbridge Ireland
Ingredient:macimorelin acetate
Patents:2
Generic Entry Opportunity 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 Strongbridge U.S. Inc 71090-002 71090-002-02 1 POUCH in 1 CARTON (71090-002-02) > 60 mg in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage: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)
Regulatory Exclusivity Expiration:Dec 20, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Aug 1, 2022Product Flag?YSubstance Flag?YDelist 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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