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Last Updated: October 1, 2020

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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
Suppliers / Packagers: 1
Bulk Api Vendors: 2
DailyMed Link:macimorelin acetate at DailyMed
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   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
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 macimorelin acetate

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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Boehringer Ingelheim
Johnson and Johnson
Merck
Dow

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