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Last Updated: September 22, 2021

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Macimorelin acetate - Generic Drug Details

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What are the generic sources for macimorelin acetate and what is the scope of patent protection?

Macimorelin acetate is the generic ingredient in one branded drug marketed by Novo and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Macimorelin acetate has seventy-three patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for macimorelin acetate
International Patents:73
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 1
What excipients (inactive ingredients) are in macimorelin acetate?macimorelin acetate excipients list
DailyMed Link:macimorelin acetate at DailyMed
Recent Clinical Trials for macimorelin acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novo Nordisk A/SPhase 3
AEterna ZentarisPhase 3

See all macimorelin acetate clinical trials

Pharmacology for macimorelin acetate

US Patents and Regulatory Information for macimorelin acetate

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

International Patents for macimorelin acetate

Country Patent Number Estimated Expiration
Australia 6606601 ⤷  Free Forever Trial
Denmark 1344773 ⤷  Free Forever Trial
Slovakia 17562002 ⤷  Free Forever Trial
European Patent Office 1289951 ⤷  Free Forever Trial
Czech Republic 303173 ⤷  Free Forever Trial
China 1736985 ⤷  Free Forever Trial
Germany 60128494 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for macimorelin acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1289951 300999 Netherlands ⤷  Free Forever Trial PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115
1289951 CA 2019 00037 Denmark ⤷  Free Forever Trial PRODUCT NAME: MACIMORELIN, EN FARMACEUTISK SAMMENSAETNING DERAF ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1337 20190115
1289951 122019000074 Germany ⤷  Free Forever 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 ⤷  Free Forever 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 C201930046 Spain ⤷  Free Forever 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:

Harvard Business School
McKesson
Express Scripts
AstraZeneca
Merck
McKinsey

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