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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

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

See drug prices for MACRILEN

Generic Entry Opportunity Date for MACRILEN

Constraining patent/regulatory exclusivity:

FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)

NDA:

205598

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.

Pharmacology for MACRILEN

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

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
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		RX	Yes	Yes
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		RX	Yes	Yes			Y	Y
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		RX	Yes	Yes

International Patents for MACRILEN

Country	Patent Number	Estimated Expiration
Japan	4932132
European Patent Office	1524272
Israel	153067
Cyprus	1107710
Hungary	0302026
Slovakia	17562002

Supplementary Protection Certificates for MACRILEN

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