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Last Updated: August 13, 2020

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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-three 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.

US ANDA Litigation and Generic Entry Outlook for Macrilen

Macrilen will be eligible for patent challenges on December 20, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MACRILEN
International Patents:73
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 7
Patent Applications: 19
Drug Prices: Drug price information for MACRILEN
DailyMed Link:MACRILEN at DailyMed
Drug patent expirations by year for MACRILEN
Drug Prices for MACRILEN

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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.

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

Supplementary Protection Certificates for MACRILEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1289951 122019000074 Germany   Start Trial PRODUCT NAME: MACIMORELIN, OPTIONAL IN FORM EINER ARZNEIMITTELZUSAMMENSETZUNG, OPTIONAL IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE MACIMORELIN ACETAT.; REGISTRATION NO/DATE: EU/1/18/1337 20190111
1289951 132019000000099 Italy   Start Trial PRODUCT NAME: MACIMORELINA, OPZIONALMENTE NELLA FORMA DI UNA COMPOSIZIONE FARMACEUTICA, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRESA MACIMORELINA ACETATO(MACIMORELIN AETERNA ZENTARIS - MACIMORELINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1337, 20190115
1289951 300999 Netherlands   Start Trial PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115
1289951 CA 2019 00037 Denmark   Start Trial PRODUCT NAME: MACIMORELIN, EN FARMACEUTISK SAMMENSAETNING DERAF ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1337 20190115
1289951 C201930046 Spain   Start Trial PRODUCT NAME: MACIMORELINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1337; DATE OF AUTHORISATION: 20190111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1337; DATE OF FIRST AUTHORISATION IN EEA: 20190111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
McKinsey
Express Scripts
AstraZeneca
Dow

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.