Last updated: February 19, 2026
What is the Drug Identified by NDC 60758-0880?
NDC 60758-0880 corresponds to Imcivree (setmelanotide). Approved by the FDA in November 2020, it is indicated for the treatment of obesity or overeating caused by rare genetic conditions such as pro-opiomelanocortin deficiency (POMC) deficiency, leptin receptor deficiency, and Bardet-Biedl syndrome (BBS).
Market Scope
The drug targets a niche segment within the obesity treatment market. Its approval addresses a rare condition, which constrains the overall sales volume but justifies premium pricing due to high unmet medical needs.
Patient Population
- Estimated prevalence for POMC deficiency and leptin receptor deficiency is approximately 1-2 individuals per million.
- Bardet-Biedl syndrome affects about 1 in 140,000 to 1 in 160,000 in the U.S.
- Total eligible patients are estimated at fewer than 2,000 in the U.S.
Market Penetration and Adoption
- As of 2023, generic obesity drugs dominate the broader market, but Imcivree's specific indication limits competition.
- Uptake depends on physician awareness, insurance coverage, and approval by payers.
- The drug has a high-cost profile, which influences payer decisions and patient access.
Pricing Strategy and Current Pricing
List Price
- The wholesale acquisition cost (WAC) in the U.S. is approximately $375,000 per year per patient (as of 2022 estimates) [1].
- The net price varies based on rebates and insurance negotiations.
Price Drivers
- Pricing reflects the rarity and severity of the conditions.
- Cost reimbursement is influenced heavily by the rarity, and the orphan drug status qualifies Imcivree for incentives under orphan drug policies.
Comparisons
| Drug |
Indication |
List Price (Annual) |
Marketed Since |
| Imcivree |
Rare genetic obesity |
~$375,000 |
2020 |
| Contrave |
General obesity |
~$450 per month |
2014 |
| Saxenda |
Chronic weight management |
~$1,350 per month |
2014 |
Note: Imcivree's high price is commensurate with other orphan drugs addressing severe or rare conditions.
Market Growth and Price Projections
Drivers of Future Market Size
- Increased diagnosis rates for lipid metabolic disorders.
- Expansion of indications, including potential off-label uses.
- Continued physician education and insurance coverage expansion.
Forecasted Revenue
| Year |
Estimated Patients Adopting (m) |
Total Market Revenue (USD millions) |
| 2023 |
100-150 |
37.5-56.3 |
| 2024 |
150-250 |
56.3-93.8 |
| 2025 |
200-400 |
75-150 |
Assumptions: Stable pricing, steady but incremental increase in diagnosed patients, and consistent payer coverage.
Price Sensitivity
- Slight reductions in list price could be offset by increased patient numbers.
- Insurance reimbursement levels will heavily influence actual net revenue.
Competitive Landscape
- No directly competing drugs are approved yet.
- Other treatments for obesity, such as liraglutide (Saxenda) and semaglutide (Wegovy), target broader populations with lower prices.
- Imcivree's market exclusivity persists until at least 2030, barring patent challenges or regulatory changes.
Regulatory and Policy Influences
- Orphan drug status grants seven years of market exclusivity.
- Improved access through patient assistance programs and insurance negotiations may boost adoption.
- Any federal policy shifts favoring affordability could pressure pricing.
Key Market Risks and Opportunities
- Risks: Slow diagnosis, payer resistance, and high cost affecting uptake.
- Opportunities: Expanded indication approvals, increased awareness of genetic obesity, and potential inclusion in combination therapies.
Summary
Imcivree (setmelanotide) market analysis highlights a niche but high-value segment within obesity treatment, strongly driven by rare genetic conditions. Price projection models suggest revenues of approximately $56-150 million from 2023 to 2025, contingent upon patient access and payer policies. Pricing remains high, justified by orphan status and limited competition.
Key Takeaways
- The drug is a high-cost treatment for rare obesity syndromes.
- The market remains small but lucrative due to orphan drug protections.
- Future growth relies on expanded indications and improved awareness.
- Payer negotiations and healthcare policies will significantly influence revenue trajectories.
- Pricing is aligned with other niche therapies, maintaining high margins amid limited volume.
FAQs
1. What are the main challenges to increasing sales of NDC 60758-0880?
Limited patient population, insurance reimbursement barriers, and high treatment costs restrict market expansion.
2. How does Imcivree compare to broader obesity drugs?
It targets a specific, genetically linked obesity subset, with a higher price point reflecting rarity and severity of genetic disorders.
3. Are there any upcoming patents or exclusivity periods that influence the market?
Yes, orphan drug exclusivity extends until at least 2030, preventing generic or biosimilar entry.
4. Could the drug's indications expand, affecting demand?
Potentially, if clinical trials demonstrate efficacy for broader obesity or related metabolic disorders.
5. How might policy changes impact pricing?
Government pressure for affordability could lead to price caps or increased access programs, influencing net revenue.
References
[1] IQVIA, "Pharmaceutical Pricing Data," 2022.
