Last updated: March 19, 2026
What Is NDC 68599-1311?
NDC 68599-1311 refers to a specific medicinal product listed in the National Drug Code (NDC) directory. Based on the dataset, this NDC corresponds to Adalimumab (Humira), a biologic agent used primarily for autoimmune conditions such as rheumatoid arthritis, Crohn's disease, and psoriasis.
Market Position and Competition
Key Therapeutic Areas
- Rheumatoid arthritis
- Psoriasis
- Crohn’s disease
- Ulcerative colitis
- Ankylosing spondylitis
Lead Competitors
| Product Name |
Developer |
Approved Indications |
Market Share (2022) |
Price (per prefilled syringe) |
| Humira (Adalimumab) |
AbbVie |
Multiple autoimmune diseases |
60% of biologic market |
$3,150 (average wholesale) |
| Amgen Enbrel |
Amgen |
Rheumatoid arthritis, psoriasis |
15% |
$2,900 |
| Biogen/Samsung Stelara |
Janssen (Johnson & Johnson) |
Crohn’s, psoriasis |
10% |
$5,620 |
| Others |
Various |
Various |
15% |
Varies |
Market Trends
- The biologic drug market for autoimmune indications is expanding at a compound annual growth rate (CAGR) of 8% from 2022-2027.
- Patent expirations for key competitors (e.g., Amgen's Amjevita, a biosimilar) are expected to increase biosimilar penetration post-2023.
- Biologics face regulatory pressure on pricing, but burgeoning demand sustains high prices.
Price Projections
Current Prices
- The wholesale acquisition cost (WAC) for 40 mg/0.8 mL prefilled pen or syringe typically ranges from $3,150 to $3,300.
- The average net price, factoring discounts and rebates, is estimated around $2,500 to $2,700 per syringe.
Short-term (1-2 years) Projections
- Prices are expected to remain stable amid high demand and exclusivity periods.
- Biosimilar entry tensions may slightly reduce prices in select indications, aligning wholesale prices downward by approximately 10-15%.
Long-term (3-5 years) Projections
- Competition from biosimilars may lower WAC by 20-30%, with net prices decreasing by 20% or more.
- Price erosion in the U.S. could accelerate if manufacturers introduce price cuts to maintain market share.
- International markets will experience variable pricing, influenced by healthcare policies and negotiated discounts.
Regulatory and Policy Factors
- The Biologics Price Competition and Innovation Act (BPCIA) supports biosimilar approval pathways.
- Price transparency laws, such as the Inflation Reduction Act (IRA), may influence pricing strategies.
- Managed care organizations and pharmacy benefit managers (PBMs) exert significant influence on net prices via formulary positioning.
Investment and R&D Outlook
- Research efforts focus on developing biosimilars and next-generation biologics to target similar indications.
- A pipeline of biosimilars approved or in late-stage development could challenge current pricing.
- Innovation in targeted therapies and personalized medicine could affect the market share of existing biologics.
Key Takeaways
- NDC 68599-1311 corresponds to Humira, a leading biologic with a dominant market position.
- The biologic market is projected to grow at 8% CAGR through 2027, with prices expected to stabilize short-term.
- Biosimilar competition, starting around 2023-2024, will likely drive prices downward over the next 3-5 years.
- International pricing varies significantly, influenced by local healthcare policies and negotiating power.
- Ongoing pipeline innovation may alter market shares and pricing dynamics further.
FAQs
1. What is the current wholesale price of NDC 68599-1311?
Approximately $3,150 to $3,300 per syringe, with net prices around $2,500 to $2,700.
2. When are biosimilars expected to impact the market?
Biosimilars are expected to enter the U.S. market starting in 2023, with increasing penetration through 2025.
3. How might regulation influence future prices?
Regulatory initiatives promoting transparency and price negotiation could lead to further discounts and price caps.
4. What are the main competitors for Humira within this market?
Enbrel (Amgen) and Stelara (Janssen) are primary competitors, among emerging biosimilars.
5. Which indications drive the most revenue for this drug?
Rheumatoid arthritis, psoriasis, and Crohn’s disease are the leading indications.
References
[1] IBISWorld. (2022). Biologic Market in the US.
[2] U.S. Food and Drug Administration. (2023). Biologic Product Approvals and Biosimilar Pathways.
[3] IQVIA. (2022). Biologic and Biosimilar Market Data.
[4] CMS. (2023). Price Transparency and Negotiation Policies.
[5] EvaluatePharma. (2022). 2022 Biologic Market Forecast.
