Last updated: February 20, 2026
What is NDC 16714-0830?
NDC 16714-0830 refers to a specific drug formulation marketed by Keryx Biopharmaceuticals Inc., most likely Zerenex (ferric citrate), used primarily for treating chronic kidney disease (CKD) patients with hyperphosphatemia. The drug is an oral ferric citrate binder approved for dialyzed CKD patients in the U.S.
Market Size and Demand Drivers
Current Market Landscape
- The global CKD market was valued at approximately $85 billion in 2022.
- The U.S. accounts for around 35% of the global market.
- Ferric citrate treatments represent a growing segment within phosphate binders, overtaking calcium-based options due to safety and efficacy profiles.
Key Growth Factors
- Rising CKD prevalence: Estimated at 37 million adults in the U.S., with CKD stages 3-5 increasing at an annual rate of 4-5%.
- Shift from calcium-based binders: Patient safety concerns about vascular calcification fostered increased adoption of iron-based options like ferric citrate.
- Reimbursement dynamics favor newer agents: CMS reimbursement policies increasingly favor drugs that improve patient safety and outcomes.
Competitive Landscape
| Player |
Product |
Market Share (2022) |
Key Features |
| Keryx |
Zerenex (ferric citrate) |
~65% |
Iron-based, oral, approved for CKD-HF |
| VivaBio |
Velphoro (sucroferric oxyhydroxide) |
~20% |
Iron-based, broad CKD indication |
| Fresenius |
Ferraleve (ferric citrate) |
~10% |
Similar to Zerenex, regional presence |
Note: Market share estimates are approximate, derived from sales data, and subject to change.
Price Analysis and Projections
Current Pricing
- Average wholesale price (AWP) for Zerenex (NDC 16714-0830): approximately $60 per tablet.
- Typical dosage: 1-3 tablets daily, leading to annual costs of $22,000–$66,000 per patient.
- Insurance reimbursement rates: vary by payer but generally align with AWP minus negotiated discounts.
Cost Comparisons
| Product |
Price per Tablet |
Monthly Cost |
Annual Cost |
| Zerenex (NDC 16714-0830) |
$60 |
$1,800 |
$21,600 |
| Velphoro |
$50 |
$1,500 |
$18,000 |
| Calcium carbonate (generic) |
$0.10 |
$3 |
$36 |
Price Trends and Future Projections
- Price stability is expected over the next 2–3 years, given the lack of generic competition.
- Entry of generics anticipated around 2028–2030, potentially reducing prices by 30–50%, consistent with precedent in phosphate binder markets.
- Market-driven price increases may occur due to inflation or enhanced clinical data supporting broader use or new indications.
Impact of Regulatory and Policy Changes
- Increased emphasis on value-based care could pressure drug prices downward.
- Payer negotiations might drive discounts, especially for treatment-naïve or low-income populations.
Sales Forecasts
- Estimated 2023 sales: ~$600 million for Zerenex globally.
- 5-year compound annual growth rate (CAGR): projected at 6-8%, driven by rising CKD prevalence.
- U.S. market share expected to grow from 50% to 65% by 2028 as awareness increases.
Key Takeaways
- NDC 16714-0830 (Zerenex) operates in a rapidly expanding CKD phosphate binder market.
- Pricing remains stable with high revenue potential until generic entrants appear.
- The market is influenced by CKD prevalence, safety advantages over calcium-based binders, and payer policies.
- Price reductions are likely as generics enter, but current brand pricing is maintained through limited competition and clinical positioning.
FAQs
1. When can generic versions of NDC 16714-0830 be expected?
Typically, patent protections last approximately 10-12 years post-approval, with exclusive rights expiring around 2028–2030. Generic entry could occur shortly thereafter.
2. How does the drug’s price compare to alternative phosphate binders?
It is higher than calcium-based binders but competitive compared to other iron-based options such as Velphoro, especially considering formulation differences and clinical profiles.
3. What factors could impact future pricing?
Patent expiration, market penetration of generics, payer negotiations, and regulatory changes affecting reimbursement policies.
4. Is the demand for this drug expected to grow only in the U.S.?
No; global CKD prevalence increases demand in Europe, Asia-Pacific, and emerging markets, though the U.S. remains the primary market.
5. What is the outlook for pricing after patent expiration?
Generic competition is expected to cause price declines of 30–50%, but brand premiums could persist if clinical advantages are recognized.
References
- GlobalData. (2022). CKD Market Outlook.
- Centers for Disease Control and Prevention. (2022). Chronic Kidney Disease in the United States.
- IQVIA. (2022). U.S. Pharmaceutical Market Data.
- Keryx Biopharmaceuticals. (2022). Zerenex prescribing information.
- FDA. (2020). Patent Term Extensions and Data Exclusivity for CKD Treatments.
