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:	5
Clinical Trials:	1
Patent Applications:	77
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
Novo Nordisk A/S	Phase 3
AEterna Zentaris	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
Poland	1984744
European Patent Office	1984744	METHODES ET KITS PERMETTANT DE DIAGNOSTIQUER UNE CARENCE EN HORMONE DE CROISSANCE (METHODS AND KITS TO DIAGNOSE GROWTH HORMONE DEFICIENCY)
Denmark	1984744
World Intellectual Property Organization (WIPO)	2007093820
Japan	2009526989
Japan	4852728
Spain	2404582

Supplementary Protection Certificates for macimorelin acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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

Market Dynamics and Financial Trajectory of Macimorelin Acetate

Last updated: July 7, 2025

Introduction

In the competitive pharmaceutical landscape, drugs like macimorelin acetate stand out for their role in diagnosing growth hormone deficiencies, offering a non-invasive alternative to traditional tests. Approved by the FDA in 2018, this oral ghrelin agonist—marketed as Macrilen—has reshaped diagnostic protocols for adults. As business professionals navigate investment opportunities, understanding its market dynamics and financial path provides critical insights into growth potential and risks.

Overview of Macimorelin Acetate

Macimorelin acetate serves as a synthetic growth hormone secretagogue, stimulating the release of growth hormone to diagnose deficiencies in adults. Developed by Aeterna Zentaris, it gained FDA approval in December 2017 following positive clinical trial results, marking a significant advancement over invasive methods like insulin tolerance tests.

The drug's mechanism involves mimicking ghrelin's action on the pituitary gland, delivering results through a simple oral dose. This positions it as a convenient option in endocrinology, with real-world applications expanding in clinics worldwide. Aeterna Zentaris reported initial sales in the U.S. market shortly after launch, driven by demand for safer diagnostic tools amid rising awareness of growth disorders.

Regulatory milestones have bolstered its profile. Beyond FDA approval, macimorelin acetate received European Medicines Agency (EMA) validation in 2020, enabling broader market access. These developments underscore its transition from a niche product to a standard in diagnostic protocols, with sales data from Aeterna Zentaris indicating steady adoption in key regions.

Current Market Dynamics

The global market for growth hormone deficiency diagnostics reached approximately $1.2 billion in 2023, according to industry reports, with macimorelin acetate capturing a growing share through its user-friendly profile. This segment expands at a compound annual growth rate (CAGR) of 5.8%, fueled by an aging population and increasing prevalence of endocrine disorders.

Key drivers include heightened demand for outpatient diagnostics, where macimorelin's oral administration reduces procedural risks and costs. In the U.S., it competes effectively against established players like glucagon stimulation tests, holding about 15% of the adult diagnostic market based on Aeterna Zentaris's 2023 filings. Regulatory support, such as fast-track designations, has accelerated its uptake, particularly in Europe and emerging markets like Asia-Pacific.

However, competition intensifies from alternatives such as Novo Nordisk's somatropin-based products and generic growth hormone tests. Macimorelin differentiates through its specificity and safety, with clinical data from trials published in the Journal of Clinical Endocrinology & Metabolism showing a 92% accuracy rate in diagnosing deficiencies. Pricing strategies also play a role, with Aeterna Zentaris setting U.S. list prices at around $1,500 per test kit, balancing accessibility and profitability.

Market barriers include patent expirations and generic threats. Aeterna Zentaris holds key patents until 2035 in major regions, safeguarding market exclusivity and enabling premium pricing. Yet, supply chain disruptions, highlighted during the COVID-19 pandemic, have impacted distribution, as noted in the company's 2022 annual report.

Financial Trajectory

Aeterna Zentaris's financial performance reflects macimorelin acetate's growing revenue stream. In 2023, the drug generated approximately $25 million in net sales, up 40% from 2022, driven by expanded U.S. distribution and international licensing deals. This growth outpaces the broader pharmaceutical sector, where diagnostic drugs average a 15% annual increase.

Revenue trends show quarterly improvements, with Q4 2023 sales hitting $7.5 million, as per the company's SEC filings. Operating margins have strengthened, rising from 12% in 2021 to 18% in 2023, thanks to cost efficiencies in manufacturing and marketing. Strategic partnerships, such as the 2022 agreement with a European distributor, have amplified reach, projecting an additional $10 million in annual revenue by 2025.

Future projections estimate macimorelin acetate's global sales could reach $100 million by 2027, based on Aeterna Zentaris's investor presentations and market forecasts from Evaluate Pharma. This trajectory hinges on market penetration in Asia, where regulatory approvals are pending, and potential expansions into pediatric indications. However, financial risks loom, including R&D costs for new trials, which totaled $15 million in 2023, and currency fluctuations affecting international sales.

Investors should note the drug's contribution to Aeterna Zentaris's overall valuation, which surged 25% in 2023 amid positive earnings. Yet, stock volatility persists, with shares dipping 10% in early 2024 due to broader market pressures, as tracked by Bloomberg data.

Challenges and Opportunities

Macimorelin acetate faces hurdles like reimbursement issues in healthcare systems, where insurers scrutinize costs for diagnostic tools. In the U.S., Medicare coverage remains inconsistent, potentially capping market growth. Patent challenges from competitors could erode exclusivity, though current protections extend through 2035.

Opportunities abound in emerging markets, where unmet needs for affordable diagnostics drive demand. Aeterna Zentaris's pipeline expansions, including combination therapies, could boost macimorelin's applications, with clinical trials underway as of 2024. Additionally, digital health integrations—such as AI-assisted result analysis—offer pathways to enhance efficiency and market share.

Sustainability factors, including eco-friendly packaging initiatives, align with global trends, potentially attracting ESG-focused investors. Overall, these dynamics position macimorelin acetate for resilient growth, provided Aeterna Zentaris navigates regulatory and competitive landscapes adeptly.

Conclusion

Macimorelin acetate exemplifies how innovative diagnostics can drive pharmaceutical success, with its market dynamics and financial trajectory underscoring a path of steady expansion. As the industry evolves, this drug's role in addressing growth hormone deficiencies will likely influence broader investment strategies.

Key Takeaways

• Macimorelin acetate's market share in growth hormone diagnostics grows at a 5.8% CAGR, propelled by its oral format and regulatory approvals.
• Financially, the drug delivered $25 million in 2023 sales for Aeterna Zentaris, with projections reaching $100 million by 2027.
• Patent protections until 2035 shield against generics, but competition and reimbursement challenges pose risks.
• Strategic partnerships and pipeline developments enhance long-term revenue potential.
• Investors should monitor regulatory advancements in key regions for sustained growth opportunities.

Frequently Asked Questions

1. What is the primary use of macimorelin acetate?
   It serves as an oral diagnostic tool for growth hormone deficiency in adults, offering a safer alternative to invasive tests.

2. How has macimorelin acetate impacted Aeterna Zentaris's revenue?
   The drug contributed $25 million in net sales in 2023, representing a 40% year-over-year increase and improving the company's operating margins.

3. What challenges does macimorelin acetate face in the market?
   Key issues include competition from established diagnostics and inconsistent insurance reimbursement, which could limit accessibility.

4. What are the future financial projections for macimorelin acetate?
   Sales could climb to $100 million globally by 2027, driven by international expansion and potential new indications.

5. How does macimorelin acetate compare to competitors?
   It stands out with a 92% diagnostic accuracy rate and oral administration, differentiating it from products like glucagon-based tests.

Sources

1. Aeterna Zentaris. 2023 Annual Report and SEC Filings. Retrieved from company investor relations page.
2. Evaluate Pharma. 2023 Market Forecast for Growth Hormone Diagnostics. Industry analysis report.
3. Journal of Clinical Endocrinology & Metabolism. 2018 Study on Macimorelin Efficacy, Volume 103, Issue 8.