MACIMORELIN ACETATE - Generic Drug Details

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 Aeterna Zentaris 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.

Two suppliers are listed for this compound.

Summary for MACIMORELIN ACETATE

International Patents:	11
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	1
Patent Applications:	13
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

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
AEterna Zentaris	Phase 3
Novo Nordisk A/S	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

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

Expired US Patents for MACIMORELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aeterna Zentaris	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017

International Patents for MACIMORELIN ACETATE

Country	Patent Number	Title	Estimated Expiration
Japan	4852728
Cyprus	1115080
Poland	1984744
Portugal	1984744

Supplementary Protection Certificates for MACIMORELIN ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1289951	300999	Netherlands		PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115
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	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	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

Market Overview and Commercial Potential for MACIMORELIN ACETATE

Last updated: February 14, 2026

Macimorelin acetate, marketed as Macrilen, is a oral ghrelin receptor agonist approved for diagnosing adult growth hormone deficiency (GHD). Its unique profile as an oral diagnostic agent positions it within niche but expanding segments of the endocrinology and diagnostic market.

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What Are the Current Development and Approval Statuses?

• Approval: The U.S. Food and Drug Administration (FDA) approved Macimorelin acetate in December 2018 for adults with GHD.

• Indications: Primarily used as a diagnostic test rather than for therapeutic treatment.

• Market Exclusivity: Patents expired or are nearing expiration; patent data from 2014 indicate a typical 20-year lifespan from filing, with some extensions possible through formulations or methods of use.

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What Is the Size of the Market for GHD Diagnostics?

The GHD diagnostic market was valued at approximately $192 million in 2021, with projections reaching $250 million by 2026. Growth drivers include:

• Aging populations with increased GHD incidence.
• Rising demand for non-invasive, oral diagnostic options.
• Enhanced awareness and diagnostic screening programs.

Note: Macimorelin's role as an oral test positions it favorably against older, injectable tests like the insulin tolerance test (ITT).

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How Does Macimorelin Acetate Compare Commercially With Other Diagnostic Agents?

Diagnostic Agent	Formulation	Regulatory Status	Market Penetration	Cost per Test
Macimorelin acetate (Macrilen)	Oral	FDA-approved (2018)	Growing	$2,500–$3,000
Insulin Tolerance Test (ITT)	Injection	Standard, widely used	High	$1,500–$2,500
arginine-GHRH test	Injection	Off-label, limited approval	Low	Variable

Macimorelin offers advantages over ITT, including ease of administration, fewer contraindications, and fewer adverse events. However, it currently dominates the diagnostic segment in the U.S.

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What Are the Key Drivers and Barriers Shaping Its Market Trajectory?

Drivers:

• Increased adoption due to ease of use.
• Potential expansion into adult and pediatric screening.
• Growing awareness of GHD diagnostics.

Barriers:

• Patent expirations threaten exclusivity.
• Cost constraints limit adoption in certain markets.
• Limited global approval—currently only FDA-approved, pending regulatory evaluations elsewhere.

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What Is the Financial Outlook for Macimorelin?

Projected revenues are modest given the niche market:

Year	Estimated Global Sales	Comments
2022	$50–$70 million	Initial growth phase with increased clinician adoption
2023	$80–$100 million	Expanded awareness and regional approvals
2025+	$100–$150 million	Potential new indications and off-label uses

Revenue growth hinges on expanding into markets like Europe and Asia, where regulatory approvals are ongoing or expected within the next 1-3 years.

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What Is the Outlook for Long-Term Market and Financial Trajectory?

• Market growth will depend on the pace of regulatory approvals outside the U.S.
• Cost reductions in production could improve margins.
• Competitive landscape may shift if new oral diagnostics emerge or biosimilars enter the market after patent expiry.
• A therapeutic off-label or approved use could substantially expand revenue streams.

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Summary of Key Market Risks and Opportunities

• Risks: Patent cliffs, market saturation, regulatory delays outside the U.S., and high test costs limiting access.
• Opportunities: Broader indications, inclusion in screening guidelines, patent extensions via new formulations, potential in pediatric diagnostics.

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Key Takeaways

• Macimorelin acetate is a niche diagnostic agent with increasing adoption in adult GHD testing.
• It benefits from its oral formulation compared to traditional injectable tests.
• The expiring patents threaten exclusivity, but market expansion and new indications can sustain growth.
• Revenue projections suggest moderate growth, heavily dependent on regulatory and reimbursement developments globally.
• Competitive pressures and pricing will influence long-term profitability.

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FAQs

1. What are the main advantages of Macimorelin acetate over traditional GHD diagnostic tests?
It is orally administered, has a lower adverse event profile, and requires less invasive procedures compared to insulin tolerance tests.

2. What are the primary markets for expansion?
Europe, Asia, and Latin America represent growth opportunities pending regional regulatory approvals.

3. How does patent expiration impact the drug's market exclusivity?
It opens potential for generic competition, exerting downward pressure on prices unless extended via new formulations or uses.

4. Is there a therapeutic role for Macimorelin acetate?
Currently, it is approved solely as a diagnostic agent; therapeutic use is not approved or evidenced.

5. What is the outlook for regulatory approvals outside the U.S.?
Regulatory review processes are underway or planned, with approvals likely within 1-3 years, which could significantly expand the market.

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References

1. U.S. Food and Drug Administration. (2018). FDA approves Macrilen to diagnose adult growth hormone deficiency.
2. GlobalData. (2022). GHD Diagnostic Market Outlook.
3. EvaluatePharma. (2021). Pharmaceutical sales data and patent expiry analysis.