MACRILEN Drug Patent Profile

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. Two suppliers are listed for this compound. Additional details are available on the macimorelin acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Macrilen

Macrilen was eligible for patent challenges on December 20, 2021.

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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	2
Patent Applications:	46
Drug Prices:	Drug price information for MACRILEN
What excipients (inactive ingredients) are in MACRILEN?	MACRILEN excipients list
DailyMed Link:	MACRILEN at DailyMed

See drug prices for MACRILEN

DrugPatentWatch^® Estimated 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.

Recent Clinical Trials for MACRILEN

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

Sponsor	Phase
VA Office of Research and Development	Phase 3
Novo Nordisk A/S	Phase 3
AEterna Zentaris	Phase 3

See all MACRILEN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MACRILEN

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

US Patents and Regulatory Information for MACRILEN

MACRILEN is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MACRILEN

FDA Regulatory Exclusivity protecting 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

See the table below for patents covering MACRILEN around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	229233	Growth hormone secretagogues
Cyprus	1107793
Czech Republic	303173	Deriváty indolu zvyšující sekreci rustového hormonu (Indole derivatives increasing growth hormone secretion)
Japan	3522265
Bulgaria	110708
Russian Federation	2270198	СРЕДСТВА, УСИЛИВАЮЩИЕ СЕКРЕЦИЮ ГОРМОНА РОСТА (AGENTS ENHANCING GROWTH HORMONE SECRETION)
Hong Kong	1054224

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	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
1289951	300999	Netherlands		PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115