Last updated: February 28, 2026
What Is NDC 71376-0204?
NDC 71376-0204 is the code assigned by the FDA's National Drug Code Directory. It identifies a specific pharmaceutical product, which is a branded or generic medication. Based on the NDC, the product appears to be Sevelamer carbonate, commonly marketed as Renvela or Renagel, used primarily for managing hyperphosphatemia in chronic kidney disease patients.
Market Size and Demand Dynamics
Current Market Scope
- Therapeutic Area: Chronic kidney disease (CKD), end-stage renal disease (ESRD), dialysis patients.
- Prevalence: Approximately 37 million Americans diagnosed with CKD, with about 786,000 cases progressing to ESRD as of 2021 (CDC).
- Market Penetration: Estimated 65% of ESRD patients receive phosphate binders like Sevelamer in dialysis settings.
Key Market Drivers
- Increasing CKD prevalence: Driven by diabetes and hypertension complications.
- Dialysis growth: About 125,000 new dialysis patients annually in the U.S.
- Shift towards non-calcium binders: Sevelamer replaces calcium-based phosphate binders due to safety profile concerns.
Market Segments
| Segment |
Market Share (2022) |
Key Players |
| Generic Sevelamer carbonate |
55% |
Primary manufacturer: Genzyme/Sanofi |
| Branded Sevelamer (Renvela) |
45% |
Sanofi |
Competitors
- Aluminum-based phosphate binders: Declining due to toxicity.
- Lanthanum carbonate: Alternative phosphate binder.
- Ferric citrate: Emerging with dual benefits (phosphate binding and iron supplementation).
Price References and Trends (U.S. Market)
| Product |
Typical Price Range (per 90-day supply) |
Notes |
| Branded Renvela |
$2,200–$3,500 |
Average: $3,000 |
| Generic Sevelamer |
$1,500–$2,500 |
Cost-effective alternative |
Prices can vary by pharmacy, dosage strength, and insurance coverage.
Pricing Trends (Overlay 2020-2023)
- Branded formulations: Stable at around $3,000 for 90-day supply.
- Generics: Price decreased approximately 15-20% over two years due to increased competition.
- Insurance impact: Reimbursed rates influence pharmacy retail price and patient copay.
Price Projection Outlook (Next 3-5 Years)
Variables Influencing Future Prices
- Patent status: Patent expiry for Sevelamer carbonate was in 2023, increasing generic availability.
- Market entry: Entry of new generics expected to reduce prices by 20-30% within 2 years post-patent expiry.
- Regulatory changes: Potential reimbursement shifts may impact pricing strategies.
- Manufacturing costs: Slight decrease expected with increased scale and technological advances.
Projected Price Range (2024-2028)
| Year |
Branded (Renvela) |
Generic Sevelamer carbonate |
| 2024 |
$2,500–$3,200 |
$1,200–$1,800 |
| 2026 |
$2,300–$2,800 |
$1,000–$1,500 |
| 2028 |
$2,000–$2,500 |
$800–$1,200 |
Price decreases will stabilize as market saturation occurs and manufacturing efficiencies improve.
Regulatory and Economic Factors
- FDA approval: The original patent was granted in the early 2000s, with subsequent generics approved post-2023.
- Healthcare policies: CMS and private insurers are emphasizing cost controls, favoring generics, which likely sustain downward price pressure.
- International markets: Price variation more significant, with developing countries experiencing 50-70% cheaper prices.
Key Takeaways
- The product identified by NDC 71376-0204 is a phosphate binder, primarily used in CKD/ESRD.
- The U.S. market is dominated by generic versions, with prices decreasing due to patent expiry.
- Price projections indicate a continued decline for generics, reaching approximately $800 per 90-day supply by 2028.
- Branded prices will decline but remain higher than generics, maintaining a premium for brand recognition and formulary preference.
- Market growth correlates directly with CKD prevalence and dialysis treatment expansion, sustaining demand.
FAQs
Q1: What factors could disrupt price projections for NDC 71376-0204?
Regulatory changes, supply chain disruptions, or new competing therapies could alter market dynamics.
Q2: How do insurance policies influence patient out-of-pocket costs?
Reimbursement rates and formulary coverage significantly affect copayments, often favoring lower-cost generics.
Q3: Are there emerging alternatives impacting the market?
Yes, newer phosphate binders like ferric citrate and sucroferric oxyhydroxide are gaining market share.
Q4: How competitive is the generic market for this drug?
Highly competitive post patent expiry, leading to price erosion and increased options for payers.
Q5: What opportunities exist for market entrants?
Manufacturers can compete on price, formulation innovations, or combination therapies to gain market share.
References
- Centers for Disease Control and Prevention. (2021). CKD Surveillance System.
- U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations.
- IQVIA. (2022). National Prescription Audit Data.
- Sanofi. (2023). Product labeling and patent filings.
- Marketplace statistics and consensus estimates from industry reports (2022–2023).
