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

Supplementary Protection Certificates for setmelanotide acetate

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

Market Dynamics and Financial Trajectory for Setmelanotide Acetate

Last updated: February 16, 2026

Setmelanotide acetate (brand name Imcivree), developed by Rhythm Pharmaceuticals, is a melanocortin-4 receptor (MC4R) agonist approved for rare genetic obesity disorders. Its market penetration and financial outlook depend on regulatory approvals, patient populations, pricing strategies, and competitive landscape.

Regulatory and Clinical Landscape

• Approval Status: Approved in the U.S. by the FDA (March 2020) for obesity caused by POMC deficiency, LEPR deficiency, or Bardet-Biedl syndrome (BBS). As of 2023, additional approvals are pending or sought in the EU and other markets.
• Indication Expansion: Trials for broader obesity indications are ongoing, but regulatory decisions remain limited to ultra-rare genetic obesity.
• Pricing and Reimbursement: The drug carries a high price point, approximately $37,500 annually per patient in the U.S., with discounts negotiated for insurance coverage. Reimbursement dynamics are critical for market access expansion.

Market Size and Patient Population

• Initial Addressable Market: Limited to patients with rare genetic obesity syndromes (estimated at fewer than 10,000 individuals in the U.S.).
• Potential Expansion: Considered for wider obesity treatment if efficacy in broader populations is demonstrated; this could multiply the market size several-fold. However, no such approvals have been secured.
• Patient Identification: Requires genetic testing, limiting early market penetration due to diagnostic availability and awareness.

Competitive Landscape

• Existing Treatments: Few options explicitly targeting genetic obesity. Off-label use of appetite suppressants or weight-loss drugs provides limited competition.
• Future Competitors: Other MC4R agonists or drugs targeting related pathways could emerge, especially if setmelanotide's trials extend to common obesity.

Revenue Projections

• 2022 Revenue: Estimated at $25 million, reflecting initial commercialization efforts and limited patient uptake.
• 2023-2025 Outlook:
  • Rapid growth driven by increased diagnosis, payer coverage, and expanded geographic presence.
  • Revenue could reach $100 million by 2025 if approvals in Europe and other jurisdictions are obtained and if promotional efforts succeed.
• Pricing Strategy Influence: The high price limits access but sustains revenue per patient. New formulations or indications could alter cost structures and reimbursement prospects.

Financial Risks and Opportunities

• Risks:
  • Limited patient population constrains revenue.
  • Delays in regulatory decisions or reimbursement barriers impact growth.
  • Competition, if drugs with broader indications gain approval.
• Opportunities:
  • Expansion into common obesity, pending positive trial outcomes.
  • Increased genetic testing and awareness raising the diagnosed population.
  • Potential partnerships for global expansion and marketing.

Market Entry and Growth Strategies

• Focus on rare disease centers for early adoption.
• Partner with diagnostic companies for genetic testing.
• Engage payers early to establish favorable reimbursement policies.
• Invest in clinical trials to support broader indications.

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Key Takeaways

• Setmelanotide's current revenue is limited to rare genetic obesity indications.
• Market growth hinges on approval expansion, patient identification, and payer coverage.
• The high price per patient ensures revenue from limited populations but restricts access.
• Future potential exists if trials demonstrate efficacy in broader obesity populations.
• Competitive pressures remain low but could increase with new entrants or indications.

FAQs

1. What is setmelanotide acetate used for?
   It treats rare genetic forms of obesity such as POMC deficiency, LEPR deficiency, and Bardet-Biedl syndrome.

2. What is the potential market size?
   Fewer than 10,000 patients in the U.S. for approved indications; broader markets depend on successful indication expansion.

3. How does pricing affect commercial success?
   The high annual cost (~$37,500) limits patient access but sustains per-patient revenue. Payer negotiation is key to broader adoption.

4. Are there any competitive drugs?
   No direct competitors for genetic obesity treatment currently; potential future entrants could change the landscape.

5. What factors could drive future growth?
   Approval in additional regions, expansion to broader obesity, increased genetic testing, and favorable reimbursement policies.

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Citations
[1] FDA approval announcement, 2020.
[2] Rhythm Pharmaceuticals public financial disclosures, 2022.
[3] Market research reports on rare obesity treatments, 2023.