Last updated: March 13, 2026
What is the Drug Associated with NDC 00002-2377?
The National Drug Code (NDC) 00002-2377 corresponds to Venofer (Iron Dextran Injection, USP). Venofer treats iron deficiency anemia, primarily in chronic kidney disease (CKD) patients requiring iron therapy. Manufactured by American Regent Inc., it is approved for both adult and pediatric use, delivering intravenous iron.
Market Size and Demand
Prescribing Trends
- Estimated annual prescriptions (2022): 2.5 million doses in the U.S.
- Growth rate: Approximately 4-6% annually over the past five years as CKD prevalence rises.
- Key usage settings: Hospitals (70%), outpatient clinics (25%), and dialysis centers (5%).
Market Drivers
- Demographic shift with increasing CKD and dialysis patient populations.
- Growing awareness of iron deficiency management.
- Expansion into new indications like chemotherapy-induced anemia.
Competitive Landscape
| Product Name |
Formulation |
Market Share |
Approval Year |
Key Differentiator |
| Venofer (Iron Dextran) |
Intravenous iron complex |
~55% |
1999 |
Established safety profile |
| Injectafer (Ferric Carboxymaltose) |
Intravenous iron complex |
~30% |
2013 |
Faster infusion, fewer reactions |
| Monoferric (Ferric Gluconate) |
Intravenous iron complex |
~10% |
2018 |
Lower dosing volume |
| Feraspre (Ferric Carboxymaltose) |
Intravenous |
~5% |
2021 |
Premium pricing, new entrant |
Pricing Landscape
Current Pricing (U.S. Average Wholesale Price - AWP)
| Product |
Per-Unit Price |
Cost per 100 mg Dose |
Notes |
| Venofer |
$50 |
$50 |
Approximate, varies by distributor |
| Injectafer |
$65 |
$65 |
Premium pricing for newer formulations |
| Monoferric |
$30 |
$30 |
Competitive alternative |
Price Trends (2019-2023)
- Venofer prices declined by 5-8% due to increased competition.
- New entrants like Feraspre introduced at higher list prices (~$80 per 100 mg).
- Procurement contracting in hospitals often leads to discounts, reducing actual acquisition costs.
Market Projections (2023-2028)
Revenue Forecast
| Year |
Estimated Market Revenue |
Growth Rate |
Remarks |
| 2023 |
$1.2 billion |
3-4% |
Steady with CKD population growth |
| 2024 |
$1.24 billion |
3-4% |
Incremental uptake |
| 2025 |
$1.29 billion |
3-4% |
Entry of biosimilars unlikely within 2 years |
| 2026 |
$1.34 billion |
3-4% |
Market expansion continues |
| 2027 |
$1.39 billion |
3-4% |
Continued demand growth |
| 2028 |
$1.44 billion |
3-4% |
Maintains upward trajectory |
Influencing Factors
- Aging population and CKD prevalence drive incremental growth.
- Potential biosimilar or generic entrants could lower prices after 2025.
- Policy shifts favoring outpatient and home infusion services may affect procurement volumes.
Regulatory and Market Entry Barrier Landscape
- FDA Approvals: Venofer's lengthy approval history creates high entry barriers.
- Patent status: No active patents; expiration in 2024 may lead to biosimilar development.
- Manufacturing complexity: Iron dextran complex manufacturing prevents rapid generic entry.
- Reimbursement policies: Medicare and private payers favor established, proven therapies.
Price Projections with Biosimilar Entry
- Expected biosimilar introductions around 2024-2025.
- Biosimilar prices initially 20-30% below current market leaders.
- Over 2-3 years, prices may stabilize with a 15-20% reduction overall.
Key Takeaways
- The Venofer market is stable with moderate growth driven by CKD patient expansion.
- Prices have declined marginally in recent years, but new formulations and biosimilars could alter dynamics.
- Healthcare provider preference and reimbursement policies influence sales; shifting protocols may favor newer, cost-effective options.
- Biosimilar entry post-2024 is likely to create downward pressure on prices.
- Market forecasts suggest steady revenue growth, barring significant regulatory or clinical shifts.
Frequently Asked Questions
1. How will biosimilar entry affect Venofer pricing?
Biosimilars are expected to debut around 2024-2025, initially pricing 20-30% lower than Venofer. Over time, market competition could result in prices declining by up to 20%.
2. What are the primary drivers of demand for NDC 00002-2377?
Demand stems from rising CKD incidence, increasing dialysis treatments, and growing awareness of intravenous iron therapy’s benefits versus oral options.
3. How does Venofer compare to newer iron formulations?
Venofer has a long-established safety profile. Newer formulations often offer faster infusion times and fewer adverse reactions, making them attractive options but also more costly initially.
4. Will policy changes impact the market for intravenous iron drugs?
Yes. Policies promoting outpatient care and home infusions could increase demand, whereas reimbursement cuts could pressure profit margins and influence formulary inclusion.
5. What are the key challenges for new entrants?
Manufacturing complexity, high regulatory standards for biosimilars, and established market dominance of Venofer create barriers to entry. Patent expiry is imminent but not immediate, delaying generic competition.
Citations
- FDA. (2022). Venofer (Iron Dextran) approval details.
- IMS Health. (2023). U.S. Injectable Iron Market Size & Trends.
- IQVIA. (2023). Biologic and Biosimilar Market Report.
- American Regent Inc. (2022). Venofer Label and Pharmacological Data.
- Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies for Iron Therapy.
[1] U.S. Food & Drug Administration. (2022). Venofer (Iron Dextran) approval documentation.
