Last updated: February 17, 2026
What is NDC 10337-0359?
NDC 10337-0359 corresponds to the drug Imcivree (setmelanotide). Approved by the FDA in November 2020, Imcivree targets obesity linked to specific genetic deficiencies, notably in patients with certain rare syndromes such as POMC deficiency and Bardet-Biedl syndrome.
Market Landscape for Imcivree
Market Size and Patient Population
- Imcivree targets a narrow subset of obesity patients with rare genetic conditions.
- Estimated eligible patient population in the U.S. stands at approximately 4,000 to 6,000 individuals nationally.
- The broader obesity market exceeds 93 million adults, but this drug is limited to genetic forms.
Competitive Environment
- Currently, no direct competitors target the same genetic markers.
- Off-label treatments and off-market management primarily involve traditional weight-loss therapies, which lack targeted mechanisms.
- The absence of direct competition enhances Imcivree’s market power within its niche.
Market Penetration Factors
- Rarity of target indications limits total addressable market.
- Approval in key territories (U.S., Europe) increases potential revenue streams.
- The drug has received orphan drug designation, which offers market exclusivity and various incentives.
Pricing and Revenue Projections
Current Pricing Structure
- The wholesale acquisition cost (WAC) of Imcivree approximates $27,000 per year per patient.
- In multiple markets, pricing varies based on healthcare systems, rebates, and insurance reimbursements.
Projected Revenue
- The initial market penetration relies heavily on prescriber adoption within the targeted clinical niche.
- Low patient numbers imply potential maximum revenue in the range of $108 million annually if 100% of the eligible population is treated.
- Realistically, 15-30% market penetration is expected in the first 5 years, translating to $16-32 million annual revenue.
Pricing Trends
- A high-cost orphan drug, similar treatments maintain stable pricing barring regulatory changes.
- Price adjustments may occur depending on negotiations with payers and changes in healthcare policies.
Pricing and Market Trends Compared
| Aspect |
Imcivree |
Typical Orphan Drugs |
Wide-Use Obesity Therapies |
| Wholesale Price |
~$27,000/year |
$50,000-$150,000/year |
$1,000-$5,000/year |
| Patient Population |
4,000-6,000 |
100,000+ |
93 million+ |
| Market Exclusivity |
7 years (US) |
7-12 years |
No exclusivity |
Future Projections & Market Dynamics
- Imcivree’s revenue will depend on expanding indications, prescriber awareness, and payer reimbursement policies.
- Expansion to related rare obesity forms or broader indications remains uncertain post-approval.
- Price increases are unlikely unless new formulations or indications are approved.
- Broader adoption may be limited by the small patient base but can sustain a niche market presence.
Key Factors Influencing Future Market and Pricing
- Regulatory decisions: Additional approvals or label expansions could increase patient access.
- Reimbursement climate: Payer acceptance and coverage will significantly impact pricing strategies.
- Competitive developments: Emergence of new therapies or generics could influence pricing.
- Manufacturing and supply chain: Influence costs and potentially impact pricing stability.
Key Takeaways
- Imcivree addresses a rare subset of genetic obesity with limited patient populations.
- The drug’s pricing is approximately $27,000 per year, with potential revenue capped by its niche.
- Significant market growth hinges on expanded indications and prescriber adoption.
- Competitive landscape remains minimal, favoring maintained market exclusivity.
- Reimbursement policies and healthcare regulations are key to pricing consistency.
Frequently Asked Questions
1. How does Imcivree compare to other obesity drugs?
Imcivree is priced higher than traditional obesity treatments, which typically cost below $5,000 annually. It is targeted for a severely limited population, unlike broader-market drugs.
2. Are there expected price hikes for Imcivree?
Price increases are unlikely unless new indications emerge or manufacturing costs change significantly. Current pricing reflects the orphan drug status and market exclusivity.
3. What risks could impact the market for Imcivree?
Risks include regulatory delays, negative reimbursement decisions, emergence of competing therapies, or discovery of adverse effects that limit its use.
4. How does patient access influence revenue?
Limited patient access due to the rarity of the condition caps total revenue. The market potential remains confined without broader indication approvals.
5. What are potential growth avenues?
Expanding indications for other genetically linked obesity forms or metabolic disorders could drive revenue growth. Payer acceptance and clinician awareness are crucial for expansion.
Sources
- FDA approval announcement for Imcivree.
- Drug pricing databases (Micromedex, GoodRx).
- Market research reports from EvaluatePharma and IQVIA.
- Orphan drug market reports (FDA, EMA).
- Prescribing information for Imcivree.
