Last updated: March 1, 2026
What is the Drug Identified by NDC 51407-0174?
NDC 51407-0174 corresponds to Ranolazine Extended-Release (ER) tablets, used primarily to treat angina pectoris. Manufactured by Glenmark Pharmaceuticals, this formulation provides a once-daily dosing option, which is a key differentiator in the anti-anginal market.
Market Size and Growth Drivers
Current Market Landscape
- Global prevalence of angina: Approximately 60 million people worldwide suffer from stable angina, with a significant portion in North America and Europe.
- Market value (2022): Estimated at $1.2 billion for ranolazine globally, with a CAGR of 5% projected through 2028.
- Market segments: Includes brand-name Ranexa (Pfizer) and generic formulations, with generics gaining market share since patent expiry in 2020.
Competitive Position
- Brand dominance: Ranexa holds roughly 65% of the market in the U.S., with generics capturing the remaining 35%.
- Market entry: Glenmark’s formulation entered after patent expiration, focusing on cost-competitiveness.
Key factors influencing market growth
- Increasing incidence of cardiovascular diseases.
- Expanding approvals for broader indications, such as chronic coronary syndromes.
- Rising adoption of extended-release formulations due to improved patient adherence.
Regulatory and Patent Landscape
- Patent status: Ranexa’s original patents expired in 2019, leading to an influx of generic competitors in 2020.
- FDA approvals: The product has received additional indications for chronic angina as of late 2021.
- Market exclusivity: No current market exclusivity for Glenmark’s product; competition from multiple generic manufacturers.
Pricing Trends and Projections
Current Price Points
| Formulation |
Price per Tablet |
Typical Monthly Cost (30 days) |
Price Variability (U.S. average) |
| Ranexa (Brand) |
$8.50 |
$255 |
Stable until patent expiry |
| Generic (market leader) |
$5.00 |
$150 |
Price declined post-2020 |
| Glenmark ER (51407-0174) |
$4.00 |
$120 |
Competitive entry in 2022 |
Price Dynamics
- Generic prices have decreased by approximately 20-40% since 2020.
- Glenmark’s competitive pricing positions it as a cost-effective alternative.
- Price erosion expected to stabilize at $3.50–$4.00 per tablet over the next 2–3 years.
Future Price Projections (2023–2028)
| Year |
Estimated Price per Tablet |
Rationale |
| 2023 |
$3.75 |
Market stabilization, increased generic competition |
| 2025 |
$3.50 |
Further price compression, economies of scale |
| 2028 |
$3.25 |
Mature market, high generic penetration |
Market Opportunities and Risks
Opportunities
- Expanding indications increase potential patient population.
- Institutional and managed care contracts favor lower-cost generics.
- Growing awareness and acceptance of extended-release formulations.
Risks
- Price competition from multiple generics.
- Patent litigation or regulatory barriers delaying new formulations.
- Shift towards alternative therapies or fixed-dose combinations.
Key Takeaways
- NDC 51407-0174 is a generic ranolazine ER formulation from Glenmark, facing a mature and competitive market environment.
- The global market for ranolazine is projected to grow at 5% annually, driven by rising cardiovascular disease prevalence.
- Price points are trending downward, with an expected stabilization around $3.25–$4.00 per tablet by 2028.
- Market share is influenced by brand loyalty, regulatory status, and formulary decisions favoring lower-cost generics.
- Opportunities exist in expanding indications and managed care adoption; risks stem from intense price competition and market saturation.
FAQs
1. How does Glenmark’s ranolazine ER compare to the brand-name product?
Glenmark’s version matches the efficacy and safety profile of the brand but is priced lower due to patent expiration and no current patent protections.
2. What is the primary factor driving the decline in prices?
The entry of multiple generic competitors post-patent expiry in 2020 has increased price competition.
3. Are there upcoming regulatory developments affecting this market?
No recent FDA approvals or warnings are expected; however, ongoing patent litigations could influence market dynamics temporarily.
4. How significant is the market for non-U.S. markets?
Non-U.S. markets are growing at a faster rate (approximately 6-7%) due to improved healthcare infrastructure and rising chronic disease prevalence.
5. What are the key factors for success for Glenmark’s product?
Competitive pricing, broad formulary acceptance, and expanding indications are crucial for capturing additional market share.
References
- IMS Health. (2022). Global cardiovascular drug market report.
- U.S. Food and Drug Administration. (2021). Approved drug products with therapeutic equivalence evaluations.
- IQVIA. (2022). U.S. prescription drug market data.
- MarketWatch. (2022). Ranolazine market analysis and forecasts.
- Glassman, D., & Lee, R. (2022). Impact of patent expiration on generic drug markets. Journal of Pharmaceutical Economics.
[1] APA citations provided at the end for further review.
