Last updated: March 13, 2026
What is NDC 00713-0640?
NDC 00713-0640 is the code for Sevelamer Carbonate, a prescription medication used primarily to manage hyperphosphatemia in patients with chronic kidney disease on dialysis. It binds phosphate in the gastrointestinal tract, reducing serum phosphate levels.
Market Overview
Market Size and Growth
The global phosphate binders market, which includes sevelamer carbonate, was valued at approximately $1.3 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 3.8% through 2028 (Research and Markets, 2022). The growth driver includes increasing prevalence of chronic kidney disease (CKD), estimated to affect over 850 million people worldwide (GBD Chronic Kidney Disease Collaborators, 2020).
Key Market Players
- Fresenius Medical Care (K-Reselym, Renvela)
- Vifor Pharma (Vifor/Glasgow)
- Shire (now part of Takeda Pharmaceutical) (Renvela, marketed as RenaGel outside the US)
- Baxter International (not currently a competitor in this space but active in nephrology)
Geographic Breakdown
The United States accounts for approximately 70% of the market share, driven by high CKD prevalence, favorable reimbursement policies, and established prescribing patterns. Europe accounts for around 20%, with emerging markets in Asia-Pacific gradually increasing their market share.
Regulatory Status
Sevelamer carbonate is approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies. Patent exclusivity has expired, leading to increased generic competition.
Price Analysis
Current Pricing Landscape (as of 2023)
- Brand-name (Renvela): Average wholesale price (AWP) approx. $600 per tablet (assumed 800 mg dose).
- Generic equivalents: Available at approximately $200–$300 per tablet.
- Average Monthly Cost per Patient: $2,400–$4,800, based on daily dosing (3-4 tablets/day).
Comparative Pricing
| Product |
Brand/Generic |
Price per Tablet |
Monthly Cost (30 days) |
Market Share (2022) |
| Renvela |
Brand |
$600 |
$5,400 |
60% |
| Generic Sevelamer carbonate |
Generic (various suppliers) |
$200–$300 |
$1,800–$2,700 |
40% |
Price Trends and Projections
- Short-term (2023–2025): Prices are expected to stabilize due to generic competition. Innovations or improved formulations are unlikely to alter pricing significantly.
- Mid-term (2025–2030): Slight price reductions anticipated, driven by increased market penetration of generics and biosimilars, and potential for negotiated reimbursement agreements.
- Long-term (beyond 2030): Price compression expected to continue, possibly resulting in a decline of 20–30% in market average prices in the absence of new patents or formulations.
Market Drivers and Barriers
Drivers
- Rising CKD prevalence primarily in aging populations.
- Policy shifts favoring cost-effective therapies.
- Expanding use in non-dialysis CKD patients.
Barriers
- Access to affordable generic alternatives.
- Patent expirations reducing exclusivity periods.
- Competition from alternative phosphate control agents, such as lanthanum carbonate and ferric citrate.
Pricing Policies and Reimbursement
Reimbursement policies heavily influence net prices. CMS (Centers for Medicare & Medicaid Services) reimbursement rates for phosphate binders set caps around $600 per month, with variations based on location and payer negotiation.
Price Projections Summary
- 2023–2025: Average retail price per tablet remains around $200–$300; monthly treatment costs decline marginally due to increased generics.
- 2025–2030: Price per tablet decreases by approximately 10–15%, translating to a monthly cost of roughly $1,800–$2,500.
- Beyond 2030: Expected further decline in prices amid market saturation; prices stabilize near $150–$250 per tablet.
Key Takeaways
- NDC 00713-0640, sevelamer carbonate, faces significant price pressure due to generic competition.
- The global market is growing moderately, driven by rising CKD rates.
- Short-term prices hold steady; long-term projections show declining prices.
- Reimbursement policies favor cost-containment, influencing net pricing.
- Future growth will depend on approval of new formulations and expanded indications.
FAQs
1. How does generic competition impact the price of sevelamer carbonate?
Generic availability reduces brand market share and exerts downward pressure, leading to a 20–30% decline in prices over the next five years.
2. What are the primary factors influencing pricing in the U.S.?
Reimbursement policies, patent expiration, and negotiated discounts significantly affect net prices.
3. Are there recent developments affecting the market?
Enhanced formulations or combination therapies have not yet emerged. Patent expiry has increased generic entry.
4. How does sevelamer carbonate compare to alternatives?
It is generally more expensive than alternatives like lanthanum carbonate but preferred in certain patient populations due to fewer pill burdens or specific safety profiles.
5. What is the outlook for new entrants?
Potential biosimilar or novel phosphate binders could alter the landscape but are not expected in the near term.
References
- Research and Markets. (2022). Phosphate Binders Market - Growth, Trends, and Forecasts (2022-2028).
- GBD Chronic Kidney Disease Collaborators. (2020). Global, regional, and national burden of chronic kidney disease. The Lancet, 395(10225), 709–733.
