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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Macimorelin acetate has eleven patent family members in ten countries.

One supplier is listed for this compound.

Summary for MACIMORELIN ACETATE

International Patents:	11
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	1
Patent Applications:	77
What excipients (inactive ingredients) are in MACIMORELIN ACETATE?	MACIMORELIN ACETATE excipients list
DailyMed Link:	MACIMORELIN ACETATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MACIMORELIN ACETATE

Generic Entry Date for MACIMORELIN ACETATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD) 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.

Recent Clinical Trials for MACIMORELIN ACETATE

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

Sponsor	Phase
Novo Nordisk A/S	Phase 3
AEterna Zentaris	Phase 3

See all MACIMORELIN ACETATE clinical trials

Pharmacology for MACIMORELIN ACETATE

Drug Class	Growth Hormone Secretagogue Receptor Agonist
Mechanism of Action	Growth Hormone Secretagogue Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for MACIMORELIN ACETATE

V04CD	Tests for pituitary function
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for MACIMORELIN ACETATE

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Glossary

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

Expired US Patents for MACIMORELIN ACETATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MACIMORELIN ACETATE

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Country	Patent Number	Title	Estimated Expiration
Japan	2009526989		⤷ Sign Up
European Patent Office	1984744	METHODES ET KITS PERMETTANT DE DIAGNOSTIQUER UNE CARENCE EN HORMONE DE CROISSANCE (METHODS AND KITS TO DIAGNOSE GROWTH HORMONE DEFICIENCY)	⤷ Sign Up
Poland	1984744		⤷ Sign Up
Spain	2404582		⤷ Sign Up
Portugal	1984744		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MACIMORELIN ACETATE

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

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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.