MACRILEN Drug Patent 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 is one patent protecting this drug.

This drug has eleven patent family members in ten 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

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Summary for MACRILEN

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	40
Drug Prices:	Drug price information for MACRILEN
What excipients (inactive ingredients) are in MACRILEN?	MACRILEN excipients list
DailyMed Link:	MACRILEN at DailyMed

Drug patent expirations by year for MACRILEN

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

Generic Entry Date for MACRILEN^: ⤷ Try a Trial* 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

Pharmacology for MACRILEN

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

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 one US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MACRILEN is ⤷ Try a Trial.

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

Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN

FDA Regulatory Exclusivity protecting MACRILEN

FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)
Exclusivity Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 MACRILEN

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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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MACRILEN

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

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Country	Patent Number	Title	Estimated Expiration
Portugal	1984744		⤷ Try a Trial
Hungary	0302026		⤷ Try a Trial
Slovakia	17562002	Zlúčeniny zvyšujúce sekréciu rastového hormónu, farmaceutický prostriedok s ich obsahom a ich použitie (Growth hormone secretagogues)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MACRILEN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1289951	300999	Netherlands	⤷ Try a Trial	PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115
1289951	CA 2019 00037	Denmark	⤷ Try a 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	⤷ Try a 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