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Generated: May 24, 2019

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MACRILEN Drug Profile

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When do Macrilen patents expire, and when can generic versions of Macrilen launch?

Macrilen is a drug marketed by Novo and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-two patent family members in thirty-one countries.

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 MACRILEN
Drug patent expirations by year for MACRILEN
Generic Entry Opportunity Date for MACRILEN
Generic Entry Date for MACRILEN*:
Constraining patent/regulatory exclusivity:
FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)
NDA:
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.

Synonyms for MACRILEN
2-amino-N-[(2R)-1-[[(1R)-1-formamido-2-(1H-indol-3-yl)ethyl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]-2-methylpropanamide
2-Amino-N-{(R)-1-[(R)-1-formylamino-2-(1H-indol-3-yl)-ethylcarbamoyl]-2-1H-indol-3-yl-ethyl}-2-methyl-propionamide
381231-18-1
8680B21W73
945212-59-9
945212-59-9 (acetate salt)
AEZS 130
AEZS-130
AEZS130
Aib-DTrp-DgTrp-CHO
Aib-Trp-gTrp-CHO acetate
AQZ1003RMG
ARD 07 acetate
ARD-07
BDBM50125886
CHEMBL2364617
CHEMBL278623
D-87575
D-87575 acetate
D-Tryptophanamide, 2-methylalanyl-N-((1R)-1-(formylamino)-2-(1H-indol-3-yl)ethyl)-, acetate (1:1)
D10562
D10563
DB13074
DTXSID40241516
EP 1572
EP 1572 acetate
EP-01572
EP-1572
EP1572
GTPL9745
JMV 1843
JMV-1843
JMV1843
Macimorelin
Macimorelin (USAN)
Macimorelin [USAN:INN]
Macimorelin acetate
Macimorelin acetate (USAN)
Macimorelin acetate [USAN]
Macrilen (TN)
N2-(2-amino-2-methylpropanoyl-N1-((1R)-1-formamido-2-(1H-indol-3-yl)ethyl)- D-tryptophanamide acetate
SB16909
SB16910
SCHEMBL1984708
UMV1843
UNII-8680B21W73
UNII-AQZ1003RMG

US Patents and Regulatory Information for MACRILEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo MACRILEN macimorelin acetate FOR SOLUTION;ORAL 205598-001 Dec 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novo MACRILEN macimorelin acetate FOR SOLUTION;ORAL 205598-001 Dec 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novo MACRILEN macimorelin acetate FOR SOLUTION;ORAL 205598-001 Dec 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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McKesson
Farmers Insurance
Johnson and Johnson

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