Last updated: February 27, 2026
What is the drug corresponding to NDC 00046-1107?
NDC (National Drug Code) 00046-1107 refers to Nifedipine Extended-Release Tablets, 30 mg, manufactured by Pfizer. Nifedipine is a calcium channel blocker used to treat hypertension and angina.
Current Market Overview
Market Size and Usage
- Global demand for nifedipine approximates $950 million annually (IQVIA, 2022).
- In the U.S., approximately 4 million prescriptions are written annually (Medicaid, 2022).
- The drug is classified as a generic, with multiple manufacturers contributing to price competition.
- Use cases include chronic hypertension management and angina relief.
Competitive Landscape
| Brand Name |
Manufacturer |
Dosage |
Market Share (US) |
Price per tablet (USD) |
Approvals |
| Adalat CC |
Bayer |
30 mg |
15% |
0.30 |
FDA |
| Nifedical |
Pfizer |
30 mg |
10% |
0.25 |
FDA |
| Generic Nifedipine |
Multiple |
30 mg |
75% |
0.20 |
FDA |
Regulatory & Patent Status
- The original patent expired in 2004.
- No current patent protections for Pfizer's NDC 00046-1107.
- Market dominance stems from generic manufacturing.
Price Trends and Projections
Historical Price Trends
- Since patent expiry, average retail price has declined from approximately $0.50 per tablet (2005) to $0.20 per tablet (2022).
- Price decreases correlate with increased generic competition and market saturation.
Future Price Projections (2023-2028)
| Year |
Projected Average Price per Tablet (USD) |
Key Drivers |
| 2023 |
0.20 |
Saturation of generics, stable demand |
| 2024 |
0.18 |
Possible slight price decrease due to increased competition |
| 2025 |
0.16 |
Price erosion from commoditization, potential supply chain efficiencies |
| 2026 |
0.15 |
Market stabilization, slight volume growth expected |
| 2027 |
0.15 |
Price plateau, steady demand |
| 2028 |
0.15 |
Continued generics presence, no new major competitors |
Factors Influencing Price
- Entry of low-cost generics reduces prices.
- Manufacturing efficiencies may enable slight price declines.
- Policy changes or procurement patterns (e.g., bulk purchasing by Medicaid) could impact prices.
- No current patent barriers or exclusivity periods influence market stability.
Market Entry and Revenue Potential
Market Entry Considerations
- Established presence of low-cost generics makes market entry challenging for new manufacturers.
- Regulatory approval is straightforward due to generic status.
- Procurement channels favor large-volume, low-cost providers.
Revenue Estimates
Assuming a mid-range 2023 sale volume of 400 million tablets:
| Price per Tablet |
Revenue (USD) |
| $0.20 |
$80 million |
| $0.15 |
$60 million |
Revenue estimates can fluctuate based on channel discounts, formulary inclusion, and regional demand.
Conclusion
The market for NDC 00046-1107 (nifedipine 30 mg extended-release tablets) remains saturated with generics, driving low retail prices. Price stability is expected over the next five years with slight downward pressure. The primary growth driver is volume, not price increases, due to limited patent protections and aggressive price competition.
Key Takeaways
- The drug market is mature, with prices trending toward $0.15–$0.20 per tablet.
- Demand remains stable, with consistent prescription volume.
- Entry barriers are minimal for generics; new entrants face intense price competition.
- Revenue potential aligns with high-volume, low-margin sales.
- Market stability depends on generic supply chain dynamics and regulatory environment.
FAQs
1. Will the price of NDC 00046-1107 increase?
No. Market saturation with generics has kept prices stable or declining. No new patent protections or exclusivities support price increases.
2. How does generic competition affect profit margins?
Intense price competition limits margins. Manufacturers maximize through high-volume sales rather than premium pricing.
3. Are there opportunities for branded versions?
Limited. The existing branded segment is small, and generics dominate due to lower costs.
4. What are key risks to revenue?
Regulatory changes, supply chain disruptions, or new low-cost generic entries could reduce sales or margins.
5. When might new formulations or innovations impact the market?
Possible if improved formulations demonstrate better efficacy or compliance, but such developments would face challenges in displacing entrenched generics.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- Medicaid. (2022). Prescription Drug Utilization Data.
- FDA. (2022). Drug Approvals and Patent Disclosures.
