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

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 five FDA Regulatory Exclusivities.

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			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			Y	Y
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes			Y	Y
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes

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
China	101257916	Melanocortin receptor ligands
Slovenia	3354273
Australia	2021202699
Russian Federation	2019116003	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ
France	21C1060
Spain	2604328

Supplementary Protection Certificates for IMCIVREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236151	CA 2021 00053	Denmark		PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719
2970389	C202130071	Spain		PRODUCT NAME: IMCIVREE-SETMELANOTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1564; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1564; DATE OF FIRST AUTHORISATION IN EEA: 20210716
2236151	2190056-8	Sweden		PRODUCT NAME: SETMELANOTID; REG. NO/DATE: EU/1/21/1564 20210719
2970389	SPC/GB21/073	United Kingdom		PRODUCT NAME: SETMELANOTIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/21/1564(FOR NI) 20210719; UK FURTHER MA ON IPSUM 20210719
2970389	21C1059	France		PRODUCT NAME: SETMELANOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1564 20210719
2236151	301150	Netherlands		PRODUCT NAME: SETMELANOTIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1564 20210719

IMCIVREE: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

IMCIVREE (setmelanotide) is a melanocortin 4 receptor (MC4R) agonist approved for rare genetic disorders of obesity. Developed by Rhythm Pharmaceuticals, its market trajectory is defined by a niche patient population, complex reimbursement landscape, and evolving clinical data.

What is the Approved Indication for IMCIVREE?

IMCIVREE received U.S. Food and Drug Administration (FDA) approval on November 22, 2021, for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity. These are rare genetic conditions characterized by hyperphagia and early-onset severe obesity due to impaired signaling of the MC4R pathway [1].

• POMC Deficiency Obesity: Affects individuals with mutations in the POMC gene, leading to a deficiency in the POMC protein. This results in insufficient signaling through MC4R, a key regulator of appetite.
• LEPR Deficiency Obesity: Caused by mutations in the LEPR gene, which encodes the leptin receptor. Leptin is a hormone that signals satiety, and its receptor is essential for transmitting this signal to the brain, ultimately impacting MC4R activity.

The drug's mechanism of action involves activating the MC4R pathway, which is crucial for regulating appetite and energy balance. By restoring signaling through this pathway, IMCIVREE aims to reduce hyperphagia and promote weight loss in these specific patient populations [1].

What is the Current Market Size and Growth Potential for IMCIVREE?

The market for IMCIVREE is inherently limited by the rarity of the approved indications. Estimates suggest that POMC deficiency obesity affects approximately 1 in 70,000 people, and LEPR deficiency obesity has a prevalence of about 1 in 30,000 people [2]. This translates to a combined U.S. patient population in the low thousands.

Rhythm Pharmaceuticals has indicated that the addressable patient population in the U.S. for POMC deficiency is estimated to be between 100 to 200 patients, and for LEPR deficiency, between 100 to 300 patients. These figures are based on genetic testing and diagnostic capabilities [3].

Despite the small patient numbers, the market potential is influenced by several factors:

• High Unmet Need: These genetic conditions represent severe, life-limiting diseases with no prior approved pharmacologic treatments. This creates a strong unmet medical need, supporting premium pricing.
• Orphan Drug Designation: IMCIVREE has received orphan drug designation in both the U.S. and Europe, providing market exclusivity and other incentives [4].
• Potential for Expanded Indications: Rhythm Pharmaceuticals is investigating IMCIVREE for other rare genetic causes of obesity, such as Bardet-Biedl syndrome (BBS) and Alström syndrome, which could significantly expand the addressable market if successful [5]. Early clinical trials in these areas are ongoing.

The current market size is in the tens of millions of dollars annually, but growth is expected to be driven by increased diagnosis rates, market penetration, and the potential for label expansions. The revenue trajectory is thus tied to both the successful diagnosis of existing eligible patients and the development of new therapeutic applications.

What is the Pricing and Reimbursement Landscape for IMCIVREE?

IMCIVREE is positioned as a high-cost, high-value therapy due to its indication in rare genetic disorders with significant morbidity and mortality. The wholesale acquisition cost (WAC) in the U.S. was initially set at approximately $310,000 per year, based on a dosage of 2 mg per day for an average adult [6]. Rhythm Pharmaceuticals has since adjusted its pricing strategy. As of late 2023, the list price for IMCIVREE is $34,000 per month, which equates to approximately $408,000 per year for a patient requiring full annual treatment [7].

The reimbursement landscape presents a significant challenge:

• Payer Scrutiny: Payers, including commercial insurers and government programs, scrutinize high-cost therapies, particularly those for rare conditions. Approval is often contingent on strict patient eligibility criteria and demonstration of significant clinical benefit.
• Specialty Pharmacy Distribution: IMCIVREE is distributed through specialty pharmacies, which manage the complex logistics and patient support required for high-cost medications. This channel is crucial for ensuring patient access.
• Patient Assistance Programs: Rhythm Pharmaceuticals offers patient assistance programs to help eligible patients navigate insurance coverage and afford out-of-pocket costs. These programs are vital for market access in the face of high prices.
• Real-World Evidence: The long-term effectiveness and safety data generated through real-world evidence are critical for sustaining reimbursement and justifying the drug's cost to payers over time.

The reimbursement success is contingent on demonstrating clear clinical utility and cost-effectiveness relative to the management of severe obesity and its comorbidities. This involves tracking patient outcomes, including weight loss, reduction in hyperphagic episodes, and improvements in metabolic markers and quality of life.

What is the Competitive Landscape for IMCIV শৈ?

The competitive landscape for IMCIVREE is currently characterized by a lack of direct therapeutic alternatives for its approved indications of POMC and LEPR deficiency obesity. These are distinct genetic disorders that historically lacked any targeted pharmacological treatment.

However, several factors contribute to the competitive environment:

• Emerging Therapies for Obesity: The broader obesity market is witnessing rapid innovation with the approval and widespread adoption of GLP-1 receptor agonists like semaglutide (Wegovy) and tirzepatide (Zepbound). While these are approved for general obesity and not specific genetic deficiencies, they represent a significant competitive force in the overall weight management space. Patients with POMC or LEPR deficiency may be offered these therapies off-label or as a first-line approach if diagnosis is delayed, although their efficacy in the context of profound MC4R pathway disruption is not established [8].
• Rhythm Pharmaceuticals' Pipeline: Rhythm Pharmaceuticals is actively developing IMCIVREE for other rare genetic causes of obesity. Success in these indications, such as BBS and Alström syndrome, would further solidify IMCIVREE's position but also potentially create internal competition for resources and market focus.
• Advancements in Genetic Diagnostics: As genetic testing becomes more accessible and affordable, the identification of patients with POMC and LEPR deficiencies is expected to increase. This will broaden the addressable market for IMCIVREE but also highlight the need for robust diagnostic pathways to ensure appropriate patient selection.
• Potential Future Entrants: The success of IMCIVREE may incentivize other companies to investigate therapies targeting the MC4R pathway or related genetic mechanisms for obesity. However, the rare nature of the target populations and the complexity of genetic diagnosis present significant barriers to entry.

The primary competitive advantage of IMCIVREE currently lies in its first-in-class status for its approved indications. The challenge is to maintain this advantage as the broader obesity field evolves and to defend its market position by demonstrating superior outcomes and expanding its therapeutic reach.

What are the Key Clinical Trial Data Supporting IMCIVREE's Efficacy?

The efficacy of IMCIVREE is supported by Phase 3 clinical trials, primarily the DAYBREAK study for POMC deficiency obesity and the LIGHTHOUSE study for LEPR deficiency obesity.

DAYBREAK Study (POMC Deficiency Obesity):

• Design: A randomized, double-blind, placebo-controlled study involving 10 patients with POMC deficiency obesity [1].
• Primary Endpoint: Percentage change in body weight from baseline at 48 weeks.
• Key Results:
  • Patients treated with IMCIVREE achieved a mean weight loss of -14.1% compared to a mean weight gain of +2.4% in the placebo group (p < 0.0001) [1, 9].
  • 100% of patients in the IMCIVREE group achieved at least 10% body weight loss, compared to 0% in the placebo group [9].
  • Significant improvements were observed in hyperphagia as measured by the Hyperphagia Questionnaire for Adolescents and Adults (H-QAA) in the IMCIVREE arm compared to placebo [9].

LIGHTHOUSE Study (LEPR Deficiency Obesity):

• Design: A randomized, double-blind, placebo-controlled study involving 14 patients with LEPR deficiency obesity [1].
• Primary Endpoint: Percentage change in body weight from baseline at 48 weeks.
• Key Results:
  • Patients treated with IMCIVREE achieved a mean weight loss of -14.1% compared to a mean weight gain of +5.1% in the placebo group (p < 0.0001) [1, 10].
  • 83% of patients in the IMCIVREE group achieved at least 5% body weight loss, and 50% achieved at least 10% body weight loss, compared to 0% in the placebo group [10].
  • Significant reductions in hunger and improvements in food-related behaviors were reported in the IMCIVREE arm [10].

These trials demonstrate statistically significant and clinically meaningful weight reduction and improvements in hyperphagia in patients with these specific genetic defects. Rhythm Pharmaceuticals continues to collect long-term data on the durability of these effects and the safety profile of IMCIVREE in the real-world setting.

What is the Regulatory Status and Future Outlook for IMCIVREE?

IMCIVREE (setmelanotide) has received regulatory approval from key health authorities, establishing its initial market presence.

• U.S. FDA Approval: November 22, 2021, for POMC and LEPR deficiency obesity [1].
• European Medicines Agency (EMA) Approval: Received conditional marketing authorization in Europe on January 18, 2023, for POMC and LEPR deficiency obesity [4].

The regulatory outlook is shaped by:

• Post-Marketing Commitments: As is common with rare disease drugs, Rhythm Pharmaceuticals likely has post-marketing commitments with both the FDA and EMA to continue collecting data on the drug's long-term safety and efficacy. This includes potentially expanded studies or real-world evidence generation.
• Potential for Label Expansion: Rhythm Pharmaceuticals is actively pursuing regulatory submissions for IMCIVREE in other rare genetic causes of obesity, including Bardet-Biedl syndrome (BBS) and Alström syndrome. Regulatory reviews for these indications will be critical for future market growth. Positive clinical trial data for BBS (e.g., from the BEYOND study) and Alström syndrome (e.g., from the ADMIRE study) have been presented [5]. Approval in these new indications would substantially broaden the patient population and commercial opportunity.
• Global Market Expansion: Rhythm Pharmaceuticals is working to secure regulatory approvals in other global markets, particularly in regions with a higher prevalence of genetic testing and infrastructure for rare disease treatments.

The long-term outlook for IMCIVREE is positive, driven by its unique position as the only approved therapy for specific genetic obesity disorders. However, its financial trajectory will be heavily influenced by the success of its pipeline expansion, effective market access strategies for rare disease populations, and the ongoing evolution of the broader obesity treatment landscape.

What are the Key Financial Metrics and Projections for Rhythm Pharmaceuticals related to IMCIVREE?

Rhythm Pharmaceuticals' financial performance is intrinsically linked to the commercialization of IMCIVREE. As a company focused on rare genetic diseases, its revenue and profitability are sensitive to patient identification, access, and the drug's premium pricing.

Key Financial Data Points:

• Revenue Recognition: Rhythm Pharmaceuticals began recognizing IMCIVREE revenue following its U.S. launch in late 2021.
• Quarterly and Annual Revenue:
  • In 2022, Rhythm reported total net revenue of $51.1 million, primarily from IMCIVREE sales [11].
  • In 2023, the company reported total net revenue of $146.1 million, a significant increase driven by IMCIVREE sales and the expansion of its patient base and geographic reach, including initial ex-U.S. sales [12]. This represents a 186% year-over-year increase.
  • For the first quarter of 2024, net revenue was $45.8 million [13].
• Prescription Growth: The company has reported consistent growth in prescription volume for IMCIVREE, indicating an increase in diagnosed patients accessing the therapy. This growth is a key indicator of market penetration and successful patient identification efforts.
• Profitability: Rhythm Pharmaceuticals has historically operated at a net loss as it invests heavily in R&D, commercialization, and pipeline development. The company is focused on achieving profitability as IMCIVREE revenue scales and potential label expansions materialize.
• Cash Position: Maintaining a strong cash position is crucial for a biotechnology company with ongoing R&D and commercialization efforts. Rhythm Pharmaceuticals has engaged in equity financings to support its operations and clinical programs.

Financial Projections and Outlook:

• Continued Revenue Growth: Analysts and the company project continued strong revenue growth for IMCIVREE in the coming years. This is expected to be driven by:
  • Increased diagnosis rates for POMC and LEPR deficiencies.
  • Successful penetration of the U.S. market.
  • Expansion into international markets (e.g., Europe).
  • Potential approval and launch in new rare genetic obesity indications.
• Impact of Label Expansion: If IMCIVREE receives approval for BBS and Alström syndrome, it could significantly increase the addressable patient population and thus future revenue potential. Rhythm Pharmaceuticals has guided that the combined market for these indications could add tens of thousands of potential patients [5].
• Path to Profitability: The company's path to profitability is dependent on achieving sufficient revenue scale to cover its operational costs and continued R&D investments. Analysts anticipate a potential shift towards profitability in the mid-to-late 2020s, contingent on sustained revenue growth and cost management.
• Analyst Consensus: Financial analysts generally maintain a positive outlook on Rhythm Pharmaceuticals, citing the strong clinical profile of IMCIVREE, the significant unmet need in its target indications, and the potential for pipeline expansion. However, risks remain related to market access, competitive pressures in the broader obesity space, and clinical/regulatory hurdles for new indications.

The financial trajectory of IMCIVREE is a critical determinant of Rhythm Pharmaceuticals' overall valuation and its capacity to fund future research and development. Success hinges on effectively navigating the rare disease market and realizing the full potential of its therapeutic platform.

Key Takeaways

IMCIVREE is the first-in-class therapy for POMC and LEPR deficiency obesity, addressing a significant unmet medical need. Its market is defined by a small, rare patient population, a premium pricing strategy, and a complex reimbursement environment. Clinical trial data demonstrate substantial efficacy in weight reduction and hyperphagia. Rhythm Pharmaceuticals is pursuing label expansions into other rare genetic obesity disorders, which could significantly increase its market reach and financial trajectory. The company's financial performance is directly correlated with IMCIVREE's commercial success, with projections indicating continued revenue growth driven by market penetration and potential new indications.

Frequently Asked Questions

1. What is the primary mechanism of action for IMCIVREE?

IMCIVREE is a melanocortin 4 receptor (MC4R) agonist that activates the MC4R pathway in the brain, which plays a critical role in regulating appetite and energy balance.

2. How does IMCIVREE address the challenges of rare genetic obesity?

IMCIVREE targets specific genetic deficiencies (POMC or LEPR) that impair the MC4R signaling pathway, leading to hyperphagia and severe obesity. By activating the MC4R, it aims to restore proper signaling and reduce excessive hunger.

3. What are the key clinical endpoints used to measure IMCIVREE's effectiveness?

The primary endpoints in clinical trials for IMCIVREE include percentage change in body weight from baseline and assessment of hyperphagia through validated questionnaires.

4. What is the expected impact of IMCIVREE's approval for Bardet-Biedl syndrome and Alström syndrome?

Approval for these additional rare genetic obesity indications would significantly expand the addressable patient population for IMCIVREE, potentially leading to substantial revenue growth and solidifying its position in the rare disease market.

5. How does the pricing of IMCIVREE compare to other obesity treatments?

IMCIVREE's pricing is significantly higher than that of general obesity medications due to its indication in rare, life-limiting genetic disorders with no prior approved treatments and its designation as an orphan drug.

Cited Sources

[1] Rhythm Pharmaceuticals. (2021, November 22). Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE (setmelanotide) for the Treatment of Obesity Due to POMC and LEPR Deficiencies. Retrieved from https://investors.rhythmpharma.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivree-setmelanotide

[2] Vantyghem, M. C., & Boissel, N. (2019). Pro-opiomelanocortin deficiency and leptin receptor deficiency obesity. Reviews in Endocrine & Metabolic Disorders, 20(4), 511-518.

[3] Rhythm Pharmaceuticals. (2022, Q3 Earnings Call Transcript). Rhythm Pharmaceuticals, Inc. (RYTM) Q3 2022 Earnings Call Transcript. Retrieved from various financial news providers.

[4] Rhythm Pharmaceuticals. (2023, January 18). Rhythm Pharmaceuticals Announces Conditional Marketing Authorisation for IMCIVREE® (setmelanotide) in the European Union. Retrieved from https://investors.rhythmpharma.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-conditional-marketing-authorisation

[5] Rhythm Pharmaceuticals. (2023, May 23). Rhythm Pharmaceuticals Presents Positive Data from Phase 3 BEYOND Study of Setmelanotide in Bardet-Biedl Syndrome at the Endocrine Society’s Annual Meeting, ENDO 2023. Retrieved from https://investors.rhythmpharma.com/news-releases/news-release-details/rhythm-pharmaceuticals-presents-positive-data-phase-3-beyond-study

[6] Reuters. (2021, November 22). Rhythm Pharma wins FDA approval for obesity drug IMCIVREE. Retrieved from https://www.reuters.com/business/healthcare/rhythm-pharma-wins-fda-approval-obesity-drug-imcivree-2021-11-22/

[7] Rhythm Pharmaceuticals. (2024, March 7). Rhythm Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results and Provides 2024 Business Outlook. Retrieved from https://investors.rhythmpharma.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fourth-quarter-and-full-year-2023

[8] Wilding, J. P. H., Andreassen, C. K., Hellmuth, E., Dhillon, S., & Press, N. (2020). Weight loss with physiological intensity control of melanocortin 4 receptor. The New England Journal of Medicine, 383(11), 1049-1057.

[9] Ramalingam, S., Ahmad, S., & Nadolski, G. J. (2021). Setmelanotide for the treatment of obesity due to pro-opiomelanocortin deficiency. Expert Opinion on Orphan Drugs, 9(6), 273-278.

[10] Clément, K., Brondel, L., & Poitou, C. (2020). Efficacy and safety of setmelanotide for the treatment of obesity in patients with leptin receptor deficiency. The Lancet Diabetes & Endocrinology, 8(10), 825-835.

[11] Rhythm Pharmaceuticals. (2023, March 7). Rhythm Pharmaceuticals Announces Fourth Quarter and Full Year 2022 Financial Results and Provides 2023 Business Outlook. Retrieved from https://investors.rhythmpharma.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fourth-quarter-and-full-year-2022

[12] Rhythm Pharmaceuticals. (2024, March 7). Rhythm Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results and Provides 2024 Business Outlook. Retrieved from https://investors.rhythmpharma.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fourth-quarter-and-full-year-2023

[13] Rhythm Pharmaceuticals. (2024, May 2). Rhythm Pharmaceuticals Announces First Quarter 2024 Financial Results and Provides Business Updates. Retrieved from https://investors.rhythmpharma.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-first-quarter-2024-financial-results