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 is one patent protecting this drug.

This drug has eleven patent family members in ten 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.

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 October 12, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MACRILEN

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
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 Loss of Exclusivity (LOE) Date for MACRILEN

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
AEterna Zentaris	Phase 3
Novo Nordisk A/S	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

US Patents and Regulatory Information for MACRILEN

MACRILEN is protected by one US patents.

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

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

Expired US Patents for MACRILEN

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

International Patents for MACRILEN

When does loss-of-exclusivity occur for MACRILEN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Denmark

European Patent Office

Japan

Poland

Portugal

Slovenia

Spain

United Kingdom

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

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1107793
Cyprus	1107710
Hong Kong	1056555
China	1736985

Supplementary Protection Certificates for MACRILEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

Market Dynamics and Financial Trajectory for MACRILEN

Last updated: July 29, 2025

Introduction

MACRILEN (macimorelin) is an oral drug approved by regulatory agencies like the U.S. Food and Drug Administration (FDA) for the diagnosis of adult growth hormone deficiency (AGHD). Developed by Aeterna Zentaris and promoted as a diagnostic agent, MACRILEN holds a unique position within the endocrinology and personalized medicine sectors. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical firms, investors, and healthcare providers.

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Market Overview

Therapeutic and Diagnostic Niche

Unlike conventional growth hormone therapies, MACRILEN does not treat AGHD but serves as a diagnostic tool to rapidly assess growth hormone secretion. The primary market comprises endocrinologists, hospitals, and diagnostic laboratories. The global market for diagnostic agents targeting hormone deficiencies is expanding, driven by increasing awareness and improved access to personalized healthcare.

Market Drivers

• Rising Prevalence of Growth Hormone Deficiency: Although relatively rare, AGHD affects an estimated 195,000 to 490,000 adults in the United States alone, with global numbers expected to grow proportionally, especially in aging populations [1].

• Shift Towards Oral Diagnostics: The convenience of oral testing compared to traditional stimulation tests requiring multiple visits and intravenous procedures enhances MACRILEN’s appeal, fostering its uptake.

• Regulatory Approvals and Adoption: As a specific, FDA-approved diagnostic, MACRILEN benefits from regulatory validation that facilitates clinical acceptance.

Market Challenges

• Limited Awareness and Adoption: Many endocrinologists remain unfamiliar with MACRILEN's benefits over existing stimulation tests, which comprise insulin tolerance tests (ITTs) or clonidine tests.

• Pricing and Reimbursement: Pricing strategies and reimbursement policies influence adoption rates, especially in markets where diagnostics are heavily scrutinized for cost-effectiveness.

• Competitive Alternatives: Traditional GH stimulation tests remain standard, and its integration is slow due to clinician familiarity and safety profiles.

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Market Dynamics

Regulatory Landscape

Since its FDA approval in 2018, MACRILEN has gained approval in at least the United States and Europe, with indications specifically for diagnosing AGHD in adults. Regulatory clarity boosts confidence among physicians, provided safety profiles are favorable.

Competitive Environment

Currently, MACRILEN’s main competition comes from existing diagnostic methods such as the insulin tolerance test (ITT) and alternative pharmacological tests like arginine or glucagon stimulation. However, MACRILEN’s oral administration and rapid single-dose testing position it advantageously.

Market Penetration and Adoption Strategies

• Educational Campaigns: Focused efforts targeting endocrinologists and diagnostic labs are essential to increase awareness. Demonstrating clinical data supporting MACRILEN’s safety and efficacy is crucial.

• Reimbursement Negotiations: Engaging payers to secure coverage can accelerate adoption, especially as healthcare systems prioritize minimally invasive diagnostics.

• Strategic Partnerships: Collaborations with large hospital networks and diagnostic chains facilitate broader distribution channels.

Emerging Market Opportunities

Global aging trends and increasing diagnosis of hormonal disorders open additional markets in Asia-Pacific, Latin America, and the Middle East. Developing region-specific regulatory approvals and marketing strategies can unlock new revenue streams.

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Financial Trajectory

Market Penetration and Revenue Forecasts

Given the small niche market, initial revenues are expected to be moderate, with growth contingent on increasing clinician adoption. Based on market size estimates and expected adoption rates, the following projections are plausible:

• Year 1-2: Limited commercial sales focused on early adopters, with annual revenues in the low millions USD.

• Year 3-5: As awareness grows, sales could accelerate, reaching $10-50 million annually in mature markets, assuming broader adoption and reimbursement pathways.

• Long-term Outlook: Expanding into emerging markets may double or triple revenue potential, especially as diagnosing AGHD becomes more routine globally.

Pricing and Costability

Pricing strategies will influence revenue streams. A premium pricing model might be justified by convenience and rapid results, but affordability considerations may lead to competitive pricing, especially in cost-sensitive markets.

Profitability Considerations

Expenses include manufacturing, regulatory compliance, marketing, and distribution. Economies of scale will improve profitability as volume increases. The company's ability to control costs and prioritize market expansion can significantly influence overall financial performance.

Investment and Valuation Outlook

While MACRILEN’s current market size limits immediate high valuation, its growth potential as the diagnostic paradigm shifts towards non-invasive, rapid testing methods positions it as a valuable asset within specialized diagnostic portfolios.

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Conclusion: Strategic Outlook

MACRILEN's niche as a rapid, oral diagnostic for AGHD offers a compelling value proposition rooted in patient convenience and clinical accuracy. Its future financial success hinges on increasing clinician awareness, favorable reimbursement policies, and geographic expansion.

Proactive engagement with healthcare providers, strategic partnerships, and regulatory diligence will be vital in realizing its market potential. With the aging population and rising demand for precision diagnostics, MACRILEN's trajectory appears cautiously optimistic, provided addressing current barriers effectively.

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Key Takeaways

• MACRILEN addresses a rare but expanding diagnostic niche in endocrinology, leveraging oral administration for rapid assay results.
• Market growth depends on clinician education, reimbursement pathways, and geographic expansion into emerging markets.
• Financial projections anticipate modest initial revenues with significant growth potential over the next 3-5 years.
• Competitive advantages include convenience, safety, and FDA approval, but widespread adoption requires targeted marketing and strategic collaborations.
• Long-term success hinges on integrating MACRILEN into clinical practice as part of a broader shift toward personalized, minimally invasive diagnostics.

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FAQs

Q1: What differentiates MACRILEN from traditional growth hormone stimulation tests?
A1: MACRILEN offers an oral, single-dose, rapid testing route, eliminating the need for intravenous procedures required by traditional tests like ITT, enhancing patient comfort and clinical efficiency.

Q2: What factors influence the adoption of MACRILEN in clinical practice?
A2: Key factors include clinician awareness, demonstrated clinical efficacy, reimbursement policies, regulatory approvals, and integration into existing diagnostic workflows.

Q3: How is MACRILEN positioned against competing diagnostic methods?
A3: Its oral administration and rapid turnaround provide advantages, yet widespread acceptance depends on clinician familiarity, cost-effectiveness, and comparative safety profiles relative to existing methods.

Q4: What growth opportunities exist for MACRILEN outside developed markets?
A4: Emerging markets with increasing healthcare infrastructure and demand for non-invasive diagnostics present opportunities, provided regulatory approvals and distribution channels are established.

Q5: What are the main risks to MACRILEN’s financial trajectory?
A5: Risks include slow clinician adoption, reimbursement challenges, regulatory hurdles in new markets, and competition from established testing protocols.

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References

[1] Ooi, K. G., & Swerdlow, A. J. (2020). Growth Hormone Deficiency in Adults: Epidemiology and Clinical Characteristics. Endocrinol Metab Clin North Am, 49(2), 223-236.