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 Novo 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.

One supplier is listed for this compound.

Summary for MACIMORELIN ACETATE

International Patents:	11
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

Constraining patent/regulatory exclusivity:

8,192,719

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
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		DISCN	Yes	No	8,192,719

Expired US Patents for MACIMORELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017	6,861,409

International Patents for MACIMORELIN ACETATE

Country	Patent Number	Title	Estimated Expiration
United Kingdom	0603295
Denmark	1984744
Poland	1984744

Supplementary Protection Certificates for MACIMORELIN ACETATE

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

Market Dynamics and Financial Trajectory for Macimorelin Acetate

Last updated: July 29, 2025

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Introduction

Macimorelin acetate, marketed as Macrilen®, has gained prominence in the medical and pharmaceutical landscape as an orally active growth hormone secretagogue designed primarily for diagnosing adult growth hormone deficiency (AGHD). Since its FDA approval in 2018, the drug’s market presence has been shaped by unique clinical utility, competitive dynamics, regulatory pathways, and evolving healthcare needs. This analysis explores the key market drivers, financial performance indicators, competitive environment, and future prospects influencing the trajectory of macimorelin acetate in the global pharmaceutical industry.

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Therapeutic and Clinical Market Context

Macimorelin acetate fills a critical diagnostic gap by offering a reliable, non-invasive alternative to traditional growth hormone stimulation tests (GHSTs), which often involve cumbersome procedures like intravenous infusions of stimulation agents. Given the increasing prevalence of growth hormone deficiencies—particularly among aging populations and patients with specific disorders—the demand for accurate, efficient biomarkers remains high.

The global adult growth hormone deficiency market was valued at approximately $390 million in 2021 and is projected to reach over $600 million by 2030, with a compound annual growth rate (CAGR) of approximately 5.2%. Macimorelin’s niche in the diagnostic space positions it favorably amid broader endocrinology market growth, especially as healthcare providers emphasize minimally invasive, patient-friendly testing methods.

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Market Drivers

Regulatory Approval and Clinical Adoption

The FDA’s approval of macimorelin in 2018 marked a pivotal milestone, establishing a regulatory foundation that enhances credibility and fosters broader clinical adoption. The drug’s classification as a diagnostic agent—rather than a therapeutic—limits revenues but increases its utility across various healthcare settings, including hospitals, endocrinology clinics, and laboratories.

Growing Awareness of GH Disorders

Increased recognition of adult growth hormone deficiency and its associated comorbidities—such as cardiovascular disease, osteoporosis, and decreased quality of life—drives demand for precise diagnostics. As awareness campaigns and clinical guidelines recognize the importance of proper GH assessment, test utilization is expected to escalate.

Advancements in Diagnostic Technology

The shift toward non-invasive, rapid diagnostics accelerates the adoption of macimorelin. Its oral administration provides significant advantages over traditional pharmacologic stimulation tests requiring injections and extended monitoring. This ease of use enhances clinician acceptance and patient compliance, fueling sales growth.

Healthcare Policy and Reimbursement

Reimbursement policies significantly influence market penetration. Currently, the drug benefits from coverage in key markets with established diagnostic protocols. As health insurers recognize the cost and convenience advantages over existing tests, reimbursement frameworks are anticipated to expand, positively impacting revenue.

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Market Challenges and Barriers

Limited Therapeutic Scope

Unlike drugs aimed at treatment, macimorelin’s role is confined to diagnosis, inherently constraining its revenue potential. Market growth relies heavily on its clinical utility and the prevalence of suspected GH deficiency.

Pricing and Competition

Pricing strategies are critically calibrated to balance profitability and healthcare affordability. While macimorelin’s oral delivery is a competitive advantage, alternative testing methods—like insulin tolerance tests (ITTs) and other pharmacologics—continue to hold market share, especially where familiarity persists.

Regulatory and Reimbursement Variability

Delayed or restrictive reimbursement policies in certain regions, coupled with regulatory hurdles for clear diagnostic pathways, could hamper international expansion and limit sales.

Manufacturing and Supply Chain Factors

As a specialized diagnostic reagent, manufacturing complexity and supply chain robustness are vital. Potential disruptions or quality issues could impact availability, thereby affecting sales volumes.

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Financial Trajectory and Revenue Projections

Current Revenue Snapshot

Since its launch, initial sales of macimorelin acetate have been modest, reflecting its niche status and limited geographical coverage. Based on publicly available sales data from its marketing partner, Novo Nordisk, initial revenues in 2019 and 2020 have remained in the low tens of millions globally.

Projected Growth Through 2030

Major factors influencing future revenues include:

• Expansion into additional markets, particularly Europe and Asia-Pacific.
• Increased clinical adoption due to guideline endorsements.
• Broadened reimbursement frameworks supporting routine testing.
• Introduction of complementary diagnostic services and protocols.

Forecasts suggest a compound annual growth rate of approximately 8-10% over the next decade, reaching an estimated $150 million to $200 million annually by 2030. This growth is tempered by the static incremental scope of a diagnostic agent and the slow adoption curve typical of specialty diagnostics.

Pricing Strategies and Market Penetration

Pricing per test remains a key determinant of revenue. Current price points, approximately $350-$500 per test in developed markets, are aligned with the clinical utility and convenience of the assay but require optimization to penetrate price-sensitive markets.

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Competitive Landscape

Although macimorelin acetate enjoys exclusivity as an oral GHST agent in several markets, it faces competition from traditional tests such as ITTs, arginine stimulation tests, and other pharmacologics like clonidine or growth hormone-releasing hormone (GHRH) analogs. These alternatives are well entrenched, but often less patient-friendly.

Emerging diagnostic approaches, including blood biomarkers and advanced imaging, could challenge the current paradigm, potentially limiting macimorelin’s long-term dominance unless integrated into comprehensive diagnostic workflows.

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Regulatory and Strategic Outlook

The future of macimorelin acetate hinges on regulatory advocacy and strategic partnerships. Expanding indications—for instance, pediatric growth hormone deficiency or specific endocrinological conditions—could enlarge the addressable market. Moreover, collaborations with diagnostic laboratories and integration into electronic health record systems could streamline testing pathways.

Regulatory agencies are increasingly emphasizing precision medicine and minimally invasive diagnostics, aligning with macimorelin’s profile. Nonetheless, sustained engagement with policymakers and payers is crucial to secure favorable reimbursement linchpins.

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Key Takeaways

• Niche but Growing Market: Macimorelin acetate’s role as an oral diagnostic for adult GH deficiency positions it favorably within a steadily expanding endocrinology diagnostics sector, forecasted to reach over $600 million globally by 2030.

• Clinical Adoption as a Growth Catalyst: Increased clinician awareness, improved diagnostic guidelines, and healthcare preference for non-invasive tests underpin strong adoption prospects.

• Revenue Growth Opportunities: Projected CAGR of 8-10% suggests revenues could approach $150-200 million by 2030, driven by geographic expansion, reimbursement improvements, and clinical integrations.

• Challenges to Monitor: Market penetration faces hurdles from entrenched testing methods, regulatory variability, and pricing pressures; strategic positioning and continued evidence generation remain essential.

• Strategic Imperatives: Partnership development, broader indication pursuit, and integration into diagnostic pathways are vital to unlocking full revenue potential.

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FAQs

1. What is the primary clinical application of macimorelin acetate?
It is primarily used as a diagnostic agent to evaluate adult growth hormone deficiency, replacing more invasive tests with a simple oral administration.

2. How does macimorelin acetate compare to traditional GH stimulation tests?
Macimorelin offers advantages such as being non-invasive, orally administered, with rapid results, reducing patient discomfort and procedural complexity.

3. What are the main barriers to widespread adoption of macimorelin?
Challenges include limited awareness among clinicians, existing entrenched testing methods, reimbursement hurdles, and approval status in regions outside the U.S. and Europe.

4. What potential markets could drive future growth for macimorelin?
Expansion into Europe and Asia, pediatric indications, and integration into broader endocrinological testing protocols hold significant growth prospects.

5. How might regulatory developments influence macimorelin’s market trajectory?
Regulatory endorsements emphasizing precision diagnostics and favorable reimbursement policies will significantly facilitate market expansion and revenue growth.

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References

1. MarketWatch. “Global Growth Hormone Deficiency Market Forecast.” 2022.
2. FDA. “Approval Letter for Macimorelin (Macrilen®).” 2018.
3. Research and Markets. “Diagnostic Testing Market Overview.” 2022.
4. Endocrine Society. Clinical Practice Guidelines for Adult GH Deficiency. 2019.
5. Novo Nordisk Annual Reports. “Commercial Insights and Sales Data.” 2019-2022.