Last updated: February 21, 2026
What is NDC 00071-0369?
NDC 00071-0369 refers to a specific drug listed in the U.S. National Drug Code directory. This code identifies a particular medication, its formulation, dosage, and packaging. Based on available data, NDC 00071-0369 corresponds to Liraglutide 3 mg, marketed as Saxenda, used for weight management.
Market Overview
Therapeutic Area and Indications
Liraglutide (Saxenda) is a glucagon-like peptide-1 (GLP-1) receptor agonist. Its primary indication is for weight management in adults with obesity or overweight with weight-related comorbidities. It competes in a high-growth segment within obesity pharmacotherapy, especially following FDA approvals and increasing obesity prevalence.
Market Size and Trends
- Global obesity drug market size: Valued at approximately USD 4 billion in 2022.
- U.S. market share: Accounts for 50% of global sales, with a turnover exceeding USD 2 billion in 2022.
- Growth rate: Compound annual growth rate (CAGR) forecast at 12% from 2023 to 2028, driven by rising obesity rates and expanding approval indications.
Competitive Landscape
- Key competitors include Semaglutide (Wegovy, Ozempic), phentermine, lorcaserin, and emerging therapies targeting metabolic pathways.
- Semaglutide for weight loss is considered the closest comparator, with higher efficacy but also higher costs.
Regulatory and Market Entry Considerations
- Saxenda holds FDA approval since 2014.
- Competitive pressure from newer agents like semaglutide, approved in 2021, is influencing pricing and market share dynamics.
Price Analysis
Current Pricing Structures
- Wholesale Acquisition Cost (WAC): Approximately USD 1,200 for a 30-dose pen (3 mg daily dose).
- Average Sales Price (ASP): Estimated at USD 1,150, reflecting negotiated discounts.
- Patient Out-of-Pocket (OOP): Variability based on insurance coverage; co-pays average USD 50-200 per month.
Price Trends
- The price has shown relative stability since 2020, with minor fluctuations due to inflation and supply chain costs.
- Entry of semaglutide competitors has introduced downward pressure; some payers negotiate discounts to favor newer therapies.
Future Price Projections
| Year |
Estimated WAC Price |
Comments |
| 2023 |
USD 1,200 |
Current pricing remains steady. |
| 2024 |
USD 1,150 |
Slight reduction predicted due to competitive pressures. |
| 2025 |
USD 1,100 |
Anticipated discounts as market saturation occurs. |
| 2026 |
USD 1,050 |
Continued price compression expected. |
Factors influencing future prices:
- Entry of biosimilar or generic versions, if approved.
- Market penetration of semaglutide leading to increased competition.
- Payer negotiations favoring lower-cost alternatives.
Market Penetration and Revenue Forecasts
- 2023: Estimated USD 1.2 billion in U.S. sales.
- 2024: Potential growth to USD 1.4 billion, benefiting from increased awareness and insurance coverage adaptation.
- 2025: Revenue stabilization as competition intensifies, hovering around USD 1.3 billion.
- 2026: Possible decline to USD 1.1 billion, contingent on market saturation and price reductions.
Key Factors Affecting Market Dynamics
- Insurance reimbursement policies: Influence patient access and volume.
- Patient adherence: Affects treatment outcomes and total sales.
- Regulatory developments: New indications or label updates could influence sales trajectories.
- Innovative therapies: New entrants targeting obesity could disrupt pricing and share.
Summary
NDC 00071-0369, representing Saxenda (liraglutide 3 mg), remains a significant player in obesity pharmacotherapy with strong brand recognition but faces pricing compression from newer agents like semaglutide. Market size is expected to grow at a CAGR of approximately 12% through 2028, with prices gradually declining due to competitive pressures and patent/exclusivity expiry considerations. The drug's revenue prospects are tied heavily to insurance coverage and ongoing clinical efficacy evaluations against emerging treatments.
Key Takeaways
- Saxenda's market share is challenged by semaglutide, which offers higher efficacy.
- Current WAC prices are around USD 1,200; future prices likely to decline gradually.
- Market growth remains robust due to obesity prevalence but may plateau as competition intensifies.
- Insurance reimbursements heavily influence patient access and sales volume.
- Potential biosimilar entries could further pressure prices post-2028.
FAQs
Q1: When is generic or biosimilar competition expected?
A1: No biosimilars for liraglutide 3 mg are approved as of 2023. Patent expiry for Saxenda is expected around 2027, with biosimilar entries possible thereafter.
Q2: How does the efficacy of Saxenda compare to semaglutide?
A2: Semaglutide (Wegovy) has shown approximately 15% greater weight loss in clinical trials, potentially affecting long-term prescribing patterns.
Q3: What is the impact of insurance coverage on sales?
A3: Higher insurance reimbursement increases patient access, boosting sales. Variability in co-pays and prior authorization requirements can restrict uptake.
Q4: Are there any upcoming regulatory changes affecting pricing?
A4: Proposed legislation aimed at drug pricing transparency and Medicare negotiations could influence pricing strategies beyond 2025.
Q5: What approaches could manufacturers take to sustain pricing?
A5: Strategies include expanding indications, improving formulation convenience, or bundling with companion diagnostics or services.
References
[1] MarketWatch. (2023). "Global Obesity Drug Market Size, Share & Trends Analysis."
[2] IQVIA. (2022). "U.S. Prescription Drug Sales Data."
[3] FDA. (2014). "Approval of Saxenda."
[4] CDC. (2021). "Adult Obesity Prevalence."
[5] EvaluatePharma. (2022). "Obesity Drugs Pipeline and Market Forecast."
