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Last Updated: December 3, 2022

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.

Two suppliers are listed for this compound.

Summary for macimorelin acetate
International Patents:73
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 1
Patent Applications: 97
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo MACRILEN macimorelin acetate FOR SOLUTION;ORAL 205598-001 Dec 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo MACRILEN macimorelin acetate FOR SOLUTION;ORAL 205598-001 Dec 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo MACRILEN macimorelin acetate FOR SOLUTION;ORAL 205598-001 Dec 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 Title Estimated Expiration
United Kingdom 0603295 See Plans and Pricing
South Korea 20030007889 See Plans and Pricing
Australia 2001266066 See Plans and Pricing
Denmark 1289951 See Plans and Pricing
China 1232507 See Plans and Pricing
Canada 2407659 SECRETAGOGUES DES HORMONES DE CROISSANCE (GROWTH HORMONE SECRETAGOGUES) See Plans and Pricing
Norway 323873 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for macimorelin acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1289951 C201930046 Spain See Plans and Pricing 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
1289951 300999 Netherlands See Plans and Pricing PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115
1289951 CA 2019 00037 Denmark See Plans and Pricing PRODUCT NAME: MACIMORELIN, EN FARMACEUTISK SAMMENSAETNING DERAF ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1337 20190115
1289951 132019000000099 Italy See Plans and Pricing 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 122019000074 Germany See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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