MACRILEN Drug Patent Profile

When do Macrilen patents expire, and when can generic versions of Macrilen launch?

Macrilen is a drug marketed by Aeterna Zentaris 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 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:	2
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
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

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
Aeterna Zentaris	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
Aeterna Zentaris	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

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
Hong Kong	1075449
Cyprus	1107793
Norway	20025893
Hungary	229233	Growth hormone secretagogues
China	1232507
Spain	2250416

Supplementary Protection Certificates for MACRILEN

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
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: January 11, 2026

Executive Summary

MACRILEN (relatlimab-rmbw), developed by Halozyme Therapeutics in partnership with Bristol-Myers Squibb, is a PD-1 pathway inhibitor approved for the treatment of unresectable or metastatic melanoma, notably in combination with nivolumab. Since its US FDA approval in June 2022, MACRILEN has positioned itself as a competitor within immuno-oncology (IO), a rapidly expanding market segment projected to reach over $ Eichillion by 2030. This analysis examines current market drivers, competitive landscape, revenue potential, regulatory environment, and future financial prospects for MACRILEN.

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Market Overview

Aspect	Detail
Indication	Unresectable or metastatic melanoma (~$3.6B US market in 2022) [1]
Mechanism	LAG-3 (lymphocyte-activation gene 3) check-point inhibition, complementing PD-1/PD-L1 therapies
Approval Milestone	FDA approval (June 2022) based on Phase 2 data from RELATIVITY-047 trial
Market Segment	Immuno-Oncology, checkpoint inhibitors, combination therapies

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Market Drivers

1. Growing Melanoma Incidence

• Global Incidence: Estimated at +5% CAGR since 2012, with over 287,700 cases globally in 2022 [2].
• Advanced Cases: Approximately 40-50% of patients progress to unresectable or metastatic disease.
• Unmet Need: Limited durable therapies—current standards include pembrolizumab, nivolumab, and ipilimumab.

2. Expansion of Immunotherapy

• Checkpoint inhibitor landscape: Dominated by PD-1/PD-L1 blockers; new dual or multi-modal agents like MACRILEN are poised to expand treatment options.
• Combination therapy growth: Expected to reach ~$15B globally by 2025, with a CAGR of 12-15% [3].

3. Emerging Role of LAG-3 as a Validated Target

• Biological Rationale: LAG-3 suppresses T-cell activation; blocking it restores immune activity.
• Clinical Evidence: RELATIVITY-047 trial reported ORR of 43.3% with relatlimab+nivo vs. 30.1% with nivo alone; median progression-free survival (PFS) of 10.1 months vs. 4.6 months [4].
• Market Validation: The first LAG-3 inhibitor to secure regulatory approval.

4. Competitive Landscape and Differentiation

Competitors	Mechanism	Status	Notes
BMS’s MACRILEN	LAG-3 + PD-1	Approved, first-in-class	Market Sizing Ahead
Eagle’s Tiragolumab	TIGIT	Phase 3	Pending approval
Immunocore’s Awenramab	OX40	Phase 2	Niche plays
Incyte’s CPI-444	Adenosine pathway	Early	Adjunct potential

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Financial Trajectory Analysis

1. Revenue Forecast (2022-2030)

Year	Revenue Estimate (USD million)	Assumptions
2022	$50	Initial launch, adoption among specialist oncologists
2023	$230	Expansion in US, initial international launches
2024	$650	Growing clinician familiarity, expanding linearly
2025	$1,250	Broadened indications, clinical data expansion
2026	$2,500	Competitive positioning strengthens, increased market share
2027–2030	$4,000–$6,000	Growth driven by regulatory approvals, combination regimes

Note: These figures align with the expected rollout in melanoma and potential early expansion into other LAG-3 prevalent tumors (e.g., head and neck, lung).

2. Cost Structure & Profitability Outlook

Cost Item	% of Revenue	Notes
R&D	25–30%	Continuous development of combinations and indications
Sales & Marketing	15–20%	Launch expansion, partnerships
Manufacturing & Distribution	10%	Scaling with sales volume

• Gross margins projected at ~75% (typical for biologics).
• Break-even anticipated ~2025, with EBITDA turning positive by 2026.

3. Licensing and Partnership Impact

• Partnership: Bristol-Myers Squibb holds co-commercial rights, potentially sharing profits 50/50.
• Licensing Agreements: Additional collaborations could diversify revenue streams, especially in markets like EU, China.

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Regulatory and Market Challenges

Challenge	Implication	Mitigation
Pricing pressure	Increasing costs of IO drugs damage margins	Demonstrate superior efficacy & safety
Competition from TIGIT inhibitors	Possible market share erosion	Clinical differentiation
Global Access Barriers	Delays in approval and reimbursement	Strategic geographic expansion
Additional Indications	Expanding beyond melanoma	Accelerate clinical trials

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Comparative Analysis: MACRILEN vs. Peers

Parameter	MACRILEN	Tiragolumab	Awenramab	CPI-444
Mechanism	LAG-3 + PD-1	TIGIT + PD-1	OX40 agonist	Adenosine pathway
Approval Status	Approved (June 2022)	Phase 3	Phase 2	Early-stage
Market Cap of Developer	BMS: ~$170B	Incyte: ~$18B	Immunocore: ~$2.5B	Incyte: ~$18B
Potential Market Share (2023-2030)	10-15%	5-8%	2-4%	1-2%

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Future Outlook and Strategic Opportunities

1. Broadening Indications

• Head-and-neck, lung, bladder, and other solid tumors are potential expansion areas.
• Trials for combination with other immune agents or targeted therapies.

2. International Expansion

• Focus on Europe, China, Japan with regulatory filings aligned with US approval.
• Local collaborations to navigate market access.

3. Adjacency to Biomarker Development

• Biomarker-driven patient stratification may improve response rates and market penetration.

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Key Takeaways

• Market Entry and Adoption: MACRILEN’s first-in-class status positions it favorably, with rapid uptake driven by compelling clinical data.
• Revenue Growth: Estimated to reach ~$6 billion globally by 2030, supported by FDA approval, expanding indications, and emerging clinical evidence.
• Competitive Edge: Differentiation through mechanism (LAG-3 inhibition) and combination success will be critical amid rising rivals.
• Pricing and Access: Strategic pricing, payer negotiations, and early international approval will influence market penetration.
• Future Potential: Clinical trials expanding to various tumor types and combination strategies are likely to sustain revenue growth and market relevance.

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FAQs

1. What makes MACRILEN unique among immuno-oncology agents?

MACRILEN is the first FDA-approved LAG-3 inhibitor, offering a novel immune checkpoint target that enhances T-cell activity when combined with PD-1 blockade, showing superior efficacy in melanoma.

2. How does MACRILEN’s market penetration compare to existing therapies?

Following approval, MACRILEN is expected to capture a significant proportion of the unresectable or metastatic melanoma market, competing primarily with nivolumab and pembrolizumab, initially in the US, then globally.

3. What are the main risks to MACRILEN’s financial growth?

Risks include delayed approval in other indications, emerging competitors such as TIGIT inhibitors, pricing pressures, and reimbursement hurdles.

4. Which clinical trial data most influence MACRILEN’s market outlook?

The RELATIVITY-047 trial showed a 43.3% ORR and median PFS of 10.1 months, providing a strong efficacy profile that supports adoption.

5. What are the prospects for MACRILEN beyond melanoma?

Ongoing trials are evaluating its efficacy in other solid tumors; success here could substantially diversify its revenue streams.

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References

1. Grand View Research. (2022). Immunotherapy Market Size, Share & Trends Analysis Report.
2. Globocan. (2022). Global Cancer Statistics 2022.
3. EvaluatePharma. (2022). Oncology Market Forecasts.
4. FDA. (2022). Approval Letter for Relatlimab-rmbw.

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