IMCIVREE Drug Patent Profile

When do Imcivree patents expire, and what generic alternatives are available?

Imcivree is a drug marketed by Rhythm and is included in one NDA. There are three patents protecting this drug.

This drug has ninety-eight patent family members in twenty-two countries.

The generic ingredient in IMCIVREE is setmelanotide acetate. One supplier is listed for this compound. Additional details are available on the setmelanotide acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Imcivree

Imcivree was eligible for patent challenges on November 25, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 4, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IMCIVREE

International Patents:	98
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	1
Drug Prices:	Drug price information for IMCIVREE
What excipients (inactive ingredients) are in IMCIVREE?	IMCIVREE excipients list
DailyMed Link:	IMCIVREE at DailyMed

See drug prices for IMCIVREE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IMCIVREE

Constraining patent/regulatory exclusivity:

11,129,869

NDA:

213793

Dosage:

SOLUTION;SUBCUTANEOUS

^*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 IMCIVREE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rhythm Pharmaceuticals, Inc.	Phase 3

See all IMCIVREE clinical trials

Pharmacology for IMCIVREE

Drug Class	Melanocortin 4 Receptor Agonist
Mechanism of Action	Melanocortin 4 Receptor Agonists

US Patents and Regulatory Information for IMCIVREE

IMCIVREE is protected by three US patents and seven FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,129,869.

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
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes	11,129,869		Y
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes	9,458,195		Y	Y

International Patents for IMCIVREE

When does loss-of-exclusivity occur for IMCIVREE?

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

Australia

Brazil

Canada

China

Denmark

European Patent Office

France

Hong Kong

Israel

Japan

Netherlands

Norway

Poland

Portugal

Russian Federation

South Korea

Spain

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 IMCIVREE around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E055154
Portugal	2548568
Hong Kong	1258965	黑皮質素受體配體 (MELANOCORTIN RECEPTOR LIGANDS)
Netherlands	301150
Portugal	3354273

Supplementary Protection Certificates for IMCIVREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2970389	2021C/551	Belgium		PRODUCT NAME: SETMELANOTIDE, ALSMEDE DOOR HET BASISOCTROOI BESCHERMDE, THERAPEUTISCH EQUIVALENTE AFGELEIDEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1564 20210719
2970389	21C1059	France		PRODUCT NAME: SETMELANOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1564 20210719
3354273	C20210041 00441	Estonia		PRODUCT NAME: SETMELANOTIID;REG NO/DATE: EU/1/21/1564; 19.07.2021
2236151	301150	Netherlands		PRODUCT NAME: SETMELANOTIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1564 20210719
2970389	CR 2021 00054	Denmark		PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719

Market Dynamics and Financial Trajectory for Imcivree (Setmelanotide)

Last updated: July 28, 2025

Introduction

Imcivree (setmelanotide), developed by Rhythm Pharmaceuticals, is a groundbreaking melanocortin 4 receptor (MC4R) agonist approved by the U.S. Food and Drug Administration (FDA) in November 2020 for treating rare obesity caused by genetic deficiencies in the leptin-melanocortin pathway. The drug’s unique mechanism targets a niche but transformative segment of obesity therapy, positioning it at a strategic intersection of rare disease treatment, personalized medicine, and specialty pharmaceuticals. This report examines the evolving market dynamics, financial projections, and competitive environment shaping Imcivree’s trajectory.

Market Landscape and Disease Epidemiology

Rare Genetic Obesity: Market Opportunity

Imcivree addresses a highly specific subset of obesity—monogenic forms caused by rare mutations in the leptin-melanocortin pathway, including POMC deficiency, LEPR deficiency, and Bardet-Biedl syndrome (BBS). Collectively, these conditions are ultra-rare, with an estimated prevalence of approximately 1-2 per million individuals globally (approximately 500-1,000 patients in the U.S.).

The broader rare obesity market encompasses multiple genetic pathways, with the US Orphan Drug Act incentivizing pharmaceutical investment via benefits like market exclusivity and tax credits. Despite limited widespread prevalence, the severity of these conditions and unmet therapeutic needs ensure high-value, targeted treatment options.

Market Drivers

• Unmet Medical Need: Treatment options are limited; prior medications lack efficacy or have significant side effects.
• Regulatory Incentives: Orphan drug designation facilitates expedited development and exclusivity.
• Reimbursement Environment: Favorable for rare disease therapies, though high per-patient costs pose challenges for payers seeking value-based pricing.

Competitive Landscape

Currently, Imcivree is the only FDA-approved pharmacotherapy specifically targeting monogenic obesity with a mechanistic approach. Other agents, such as liraglutide (Victoza) and semaglutide (Wegovy), primarily address polygenic, lifestyle-driven obesity and may indirectly influence market dynamics. No direct competitors targeting the melanocortin pathway exist at scale, reinforcing Imcivree’s unique position.

Pharmaceutical Development and Regulatory Milestones

Clinical and Regulatory Progress

Imcivree’s approval was primarily based on pivotal Phase 3 clinical trials demonstrating significant weight reduction and improved metabolic parameters in patients with POMC and LEPR deficiencies [1].

Rhythm Pharmaceuticals has received orphan drug and rare pediatric disease designations, which provide market exclusivity until at least 2030 and potential priority review pathways. The company is also pursuing expanded indications, such as BBS, to broaden the drug’s approval scope.

Ongoing & Future Clinical Trials

Key development initiatives include:

• Extended studies assessing long-term safety and durability.
• Trials for BBS population, a recognized subset with significant unmet need.
• Exploration of Imcivree’s utility for broader obesity phenotypes incorporating melanocortin system dysregulation.

Market Penetration and Commercial Strategy

Initial Adoption and Prescribing Trends

Initial uptake has been cautious but steady, driven by:

• Limited awareness among physicians outside specialist centers.
• The ultra-rare nature constraining large-scale commercialization.
• High treatment costs, approximately $375,000 annually per patient, impacting payer adoption.

Reimbursement and Pricing Dynamics

Reimbursement negotiations are complex, balancing high per-patient costs against the profound unmet need. Payers often require extensive evidence of clinical benefit, which can slow reimbursement processes. The company’s health economics strategies and patient advocacy efforts are critical to accelerate access.

Market Expansion Outlook

Potential increases hinge on:

• Broader indication approvals (e.g., BBS, other genetic forms).
• Expansion into geographically diverse markets, notably Europe and Asia.
• Partnerships with specialty clinics and genetics centers.

Financial Trajectory and Revenue Projections

Revenue Estimates

Rhythm Pharmaceuticals reported $8.6 million in U.S. net product sales in Q3 2022, reflecting early adoption [2]. Given the limited patient population, revenue growth depends largely on:

• Increased prescriber awareness.
• Expanded indications.
• Competitive pricing negotiations.

Growth Factors

• Targeted Patient Management: Establishing diagnosis pathways through genetic testing is vital.
• Pricing Strategy: Maintaining a balance between profitability and payer acceptance.
• Market Penetration: Building partnerships with specialty clinics and leveraging healthcare provider education.

Long-Term Revenue Outlook

Analysts project that with expanded indications and broader geographic penetration, Imcivree could achieve peak sales of $250-$400 million over the next 5-7 years, primarily within North America and Europe. However, revenue realization is likely to be incremental due to the ultra-rare disease landscape and pricing complexities.

Competitive and Market Challenges

• Limited Patient Demographics: Rarity constrains scalable revenue, requiring high per-patient pricing.
• Competitive Innovation: Future therapies targeting similar pathways or gene-editing approaches could challenge Imcivree’s market dominance.
• Regulatory and Payer Pushback: Cost-containment measures and value-based pricing models could affect reimbursement.

Strategic Opportunities

• Gene Therapy Partnerships: Exploring integration of gene editing that may offer curative potential.
• Diagnostic Positioning: Investing in genetic testing to streamline diagnosis and identify eligible patients.
• Pipeline Expansion: Developing complementary therapies targeting broader obesity pathways.

Conclusion

Imcivree’s niche positioning within the rare genetic obesity space offers both significant opportunities and inherent challenges. While the market is limited, the high unmet need, attractive regulatory incentives, and lack of direct competitors underpin its long-term value proposition. Financial growth hinges on expanding indications, improving diagnosis rates, and navigating high costs with effective payer engagement strategies.

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Key Takeaways

• Imcivree targets ultra-rare genetic obesity conditions, housing a high-value niche yet constricted by small patient populations.
• Market growth prospects depend heavily on expanding indications, geographic accessibility, and clinician awareness.
• Revenue at this stage remains modest but has potential for sustainable growth aligned with ongoing clinical development.
• Strategic collaborations, diagnostic advancements, and payer negotiations are key to unlocking commercial potential.
• The evolving landscape of personalized medicine and gene therapies may influence future competition and therapeutic approaches.

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FAQs

1. What makes Imcivree unique compared to other obesity treatments?
Imcivree is the first FDA-approved therapy specifically targeting monogenic obesity caused by deficiencies in the leptin-melanocortin pathway, offering a mechanism-based, personalized treatment option for a highly targeted patient population.

2. How significant is the market for Imcivree globally?
Given the ultra-rare prevalence (~1-2 per million), the global market encompasses only a few thousand patients. Its primary commercial impact will come in North America and Europe, where regulatory pathways are more established.

3. What are the major barriers to Imcivree’s growth?
Key barriers include high treatment costs, limited awareness among clinicians, challenges in diagnosing rare genetic disorders, and payer reimbursement restrictions.

4. Are there ongoing efforts to expand Imcivree’s indications?
Yes, Rhythm Pharmaceuticals is conducting clinical trials for additional conditions like Bardet-Biedl syndrome and exploring broader obesity phenotypes, which could significantly expand its addressable market.

5. How might competitive therapies impact Imcivree’s future?
Emerging gene therapies or novel pharmacological agents targeting similar pathways could challenge Imcivree’s market share, especially if they offer curative or more cost-effective options.

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References

1. FDA. (2020). FDA approves Imcivree to treat rare genetic obesity.
2. Rhythm Pharmaceuticals. (2022). Q3 2022 Financial Results.