Setmelanotide acetate - Generic Drug Details

What are the generic sources for setmelanotide acetate and what is the scope of freedom to operate?

Setmelanotide acetate is the generic ingredient in one branded drug marketed by Rhythm and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Setmelanotide acetate has ninety-eight patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for setmelanotide acetate

International Patents:	98
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
DailyMed Link:	setmelanotide acetate at DailyMed

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

Constraining patent/regulatory exclusivity:

11,129,869

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.

Pharmacology for setmelanotide acetate

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

Anatomical Therapeutic Chemical (ATC) Classes for setmelanotide acetate

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for setmelanotide acetate

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
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

International Patents for setmelanotide acetate

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

Supplementary Protection Certificates for setmelanotide acetate

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

Market Dynamics and Financial Trajectory for Setmelanotide Acetate

Last updated: July 31, 2025

Introduction

Setmelanotide acetate, commercially known as Imcivree, is a first-in-class melanocortin-4 receptor (MC4R) agonist, developed primarily for rare genetic disorders characterized by severe obesity, such as Bardet-Biedl syndrome (BBS) and Alström syndrome. Its unique mechanism addresses the underlying genetic defect in appetite regulation, marking a significant innovation in obesity pharmacotherapy. This report analyzes market dynamics and financial prospects influencing Setmelanotide acetate's trajectory, providing critical insights for stakeholders and investors.

Market Overview and Epidemiology

Global obesity prevalence has escalated over the past decades, translating into substantial economic costs. However, for Setmelanotide acetate, the key target market comprises ultra-rare genetic obesity syndromes. Bardet-Biedl syndrome, with an estimated prevalence of 1 in 140,000 to 160,000 live births, and Alström syndrome, approximately 1 in 1 million, are primary indications (1). These populations, though small, face limited treatment options and significant health burdens, positioning Setmelanotide as a targeted therapy with high unmet medical need.

The rarity of these syndromes classifies them within the Orphan Drug paradigm, ensuring incentives such as market exclusivity, tax credits, and grants, which influence both market dynamics and revenue potential. Commercial viability hinges on access to a small yet critically underserved patient population.

Regulatory and Reimbursement Landscape

Setmelanotide received FDA approval in November 2020 after demonstrating efficacy in phase 3 trials involving rare obesity syndromes. The European Medicines Agency (EMA) granted conditional approval in 2022. Orphan drug designation facilitates accelerated approval pathways and extended exclusivity periods, bolstering financial prospects.

Reimbursement policies significantly impact sales, especially in countries with stringent healthcare budgets. The drug's high cost, justified by its targeted indication, could pose barriers in certain markets, though patient advocacy and demonstrated long-term benefits may favor favorable reimbursement decisions.

Competitive Environment

Currently, Setmelanotide faces minimal direct competition given the scarcity of effective therapies for these conditions. However, the broader obesity pharmacology landscape is crowded with drugs like liraglutide and semaglutide, which, although targeting common obesity, do not address genetic causes. Future pipeline entrants targeting similar pathways or broader obesity indications may influence its market share.

The unique positioning of Setmelanotide as an orphan, niche therapy provides a competitive advantage, but the long-term landscape could evolve with novel gene therapies or biologics entering the arena.

Market Adoption Drivers

Several factors will determine the commercial success of Setmelanotide:

• Physician Awareness & Diagnosis: Due to the rarity and complexity of syndromes, improved genetic screening and clinician education are essential for accurate diagnosis and prescribing.
• Patient Access & Reimbursement: Payer willingness to reimburse high-cost treatments will directly affect sales volumes.
• Therapeutic Efficacy & Safety Profile: Ongoing data demonstrating sustained weight loss and acceptable safety will promote adoption.
• Manufacturing & Supply Chain: Consistent supply and scalable manufacturing processes are critical to meet demand and ensure revenue stability.

Financial Trajectory and Revenue Potential

Current Financial Position

As of 2023, Rhythm Pharmaceuticals, the developer of Setmelanotide, reported revenues primarily from a combination of collaboration agreements and initial sales following FDA approval. The company’s revenue was modest, with a limited patient base, reflecting the drug's niche application.

Sales Forecasting

Revenue potential hinges on several key assumptions:

• Market Penetration Rate: Given the small population, annual sales are projected in the tens of millions USD initially, with potential growth as diagnosis improves.
• Pricing Strategy: Prices per treatment course are estimated to range between $375,000 and $450,000 based on existing reimbursement patterns (2). Reimbursement negotiations are crucial.
• Patient Growth: With increased awareness and genetic screening, the diagnosed patient pool could expand by 10-20% annually, albeit within a small base.

Long-term Outlook

In an optimistic scenario emphasizing broad adoption among diagnosed patients, Setmelanotide could generate peak annual revenues exceeding $200 million within a decade. However, market penetration will likely remain constrained by the ultra-rare disease classification, high treatment costs, and reimbursement hurdles.

R&D pipeline advancements, potential indications expansion, or combination therapies could alter this trajectory, possibly unlocking additional markets. Yet, given the current scope, revenues will predominantly stem from the existing genetic syndromes.

Market Risks and Challenges

Key risks include:

• Regulatory Setbacks: Approval delays or restrictions could impact market entry.
• Pricing and Reimbursement Hurdles: Payer pushback against high-cost orphan drugs may limit access.
• Competitive Emergence: Development of alternative therapies or gene-editing approaches may threaten Setmelanotide’s market position.
• Patient Identification Challenges: Underdiagnosis and misdiagnosis may constrain market size.

Strategic Outlook

Maximizing the financial trajectory requires strategic focus on:

• Expanding Diagnostic Capabilities: Investing in genetic screening programs.
• Enhancing Physician Engagement: Facilitating disease awareness initiatives.
• Strengthening Reimbursement Negotiations: Demonstrating long-term cost savings through improved health outcomes.
• Pipeline Diversification: Developing applications for broader obesity disorders or metabolic syndromes.

Key Takeaways

• Market niche: Setmelanotide’s prospects remain confined to small, genetically defined obesity syndromes, demanding a careful valuation of revenue potential.
• Regulatory support: Orphan drug designation and approval pathways provide revenue protections but also impose limitations on market size.
• Pricing and reimbursement: High per-patient treatment costs necessitate strong payer engagement and value demonstration.
• Growth opportunities: Increased diagnosis, expanded indications, and pipeline innovations could improve long-term revenues.
• Competitive landscape: Minimal current competition underscores the importance of continuous innovation and advocacy for ultra-rare conditions.

FAQs

1. What are the primary indications for Setmelanotide acetate?
Setmelanotide is approved for obesity caused by rare genetic syndromes such as Bardet-Biedl and Alström syndromes, conditions characterized by severe, early-onset obesity due to defective appetite regulation pathways.

2. How large is the potential patient population for Setmelanotide?
Estimated prevalence ranges from 1 in 140,000 to 1 million, representing a few thousand patients globally. The actual diagnosed and treated population is likely smaller, emphasizing the drug’s ultra-orphan market.

3. What are the key factors influencing its market penetration?
Diagnosis accuracy, physician awareness, reimbursement policies, safety profile, and price significantly impact adoption rates. Educational initiatives and genetic screening programs can enhance market penetration.

4. What is the revenue outlook for Setmelanotide over the next decade?
Initially modest, revenues could grow to hundreds of millions USD annually if diagnosis expands and reimbursement is favorable, but overall market volume remains limited by the rarity of target conditions.

5. How might future therapies affect Setmelanotide’s market position?
Emerging gene therapies or alternative pharmacologic agents targeting similar pathways could challenge Setmelanotide’s dominance, especially if they demonstrate superior efficacy, safety, or cost-effectiveness.

References

1. [1] Clinical and epidemiological data on rare obesity syndromes.
2. [2] Pricing reports for orphan drugs in rare metabolic conditions.