Last updated: July 28, 2025
Introduction
NDC 62135-0817 corresponds to Simvastatin oral tablets, a lipid-lowering agent widely prescribed for hypercholesterolemia and cardiovascular risk management. As a generic medication, its market dynamics profoundly influence wholesale and retail pricing, reimbursement policies, and pharmaceutical innovation. This analysis offers a comprehensive review of the current market landscape, competitive positioning, regulatory environment, and future price projections for this specific NDC.
Current Market Landscape
1. Product Profile and Market Penetration
Simvastatin, a first-generation statin, has been a mainstay in cholesterol management since its FDA approval in 1991. The NDC 62135-0817 specifies a 20 mg dosage tablet, a common strength indicated for initial therapy and maintenance. Its extensive use, established safety profile, and cost-effectiveness have cemented its presence globally.
Market penetration remains high within the statin class — notably due to its cost advantage over newer, branded alternatives like atorvastatin and rosuvastatin. The generic status of NDC 62135-0817 facilitates broad access, especially via Medicaid, Medicare plans, and private insurers aiming to control drug spend.
2. Competitive Landscape
The statin market is saturated, with several generics and a few branded entities. Key competitors include:
- Atorvastatin (Lipitor): Dominant in the late 2000s but faced generic competition since 2011, impacting pricing.
- Rosuvastatin (Crestor): Slightly newer, with higher potency, maintained premium positioning.
- Lovastatin and Pravastatin: Older generics, with less efficacy and market share.
Within this landscape, Simvastatin's market share has diminished somewhat owing to the advent of more potent statins with better lipid profiles. Nonetheless, due to its affordability and familiarity, it retains consistent prescription volumes.
3. Regulatory and Reimbursement Considerations
The FDA's approval of multiple generics has significantly contributed to competitive pricing. Additionally, payers favor cost-effective options like simvastatin, which benefits market stability despite newer alternatives’ presence.
Healthcare policies emphasizing value-based care amplify the importance of low-cost generics in formulary selections, further reinforcing NDC 62135-0817’s market position.
Pricing Dynamics
1. Current Pricing
Based on recent data (2022–2023), the average wholesale price (AWP) for NDC 62135-0817 (20 mg tablets) has experienced gradual decline:
- Wholesale Acquisition Cost (WAC): Approximately $0.07 to $0.10 per tablet.
- Average Retail Price: Circa $0.12 per tablet, though discounts, rebates, and insurance coverage often reduce patient out-of-pocket costs.
The pricing trend underscores the competitive pressure among generic manufacturers, driving down prices over time.
2. Impact of Market Competition
The intense competition among multiple manufacturers producing indistinguishable formulations leads to aggressive price undercutting. As more manufacturers enter the market, prices tend to stabilize at low levels but are unlikely to fall below a certain threshold due to manufacturing costs and regulatory compliance.
3. Price Elasticity and Prescriber Behavior
Despite aggressive pricing, prescriber preference remains influenced by clinical efficacy rather than cost alone. However, formulary placements and insurance formularies heavily favor the lowest-cost options like NDC 62135-0817, emphasizing cost-conscious prescribing behaviors.
Future Price Projections
1. Market Trends and Drivers
- Generic Market Expansion: Continuing entry of manufacturers likely sustains low prices due to competition.
- Regulatory Environment: The FDA's push toward biosimilars and complex generics may further reduce prices or introduce new formulation options.
- Payer Policies: Increased emphasis on value-based formularies will sustain or lower current price points for cost-effective generics.
- Patent and Exclusivity Expirations: While simvastatin’s patent expired decades ago, patent protections for formulations or combinations could influence pricing dynamics if introduced.
2. Price Evolution Outlook (Next 3–5 Years)
Projected trends suggest:
- Minor Price Decline: Wholesale prices may decrease by approximately 5–10% annually, driven by increased generic competition.
- Market Saturation Effects: Pricing may stabilize around $0.05–$0.08 per tablet due to manufacturing costs and regulatory thresholds.
- Potential Disruption: Introduction of fixed-dose combinations (e.g., simvastatin + ezetimibe) or biosimilar-like products could alter market shares and prices but are less likely for registrational originator NDCs like 62135-0817.
3. Key Considerations for Stakeholders
- Manufacturers should seek cost efficiencies and explore novel formulations to maintain margins.
- Payers and Formularies will continue favoring lowest-cost generics, reinforcing downward pressure.
- Pharmaceutical companies may explore value-added therapies or combination products to sustain revenue.
Regulatory and Market Risks
- Regulatory Changes: Stringent manufacturing standards could elevate costs for producers, marginally increasing prices.
- Market Entrants: New generics or biosimilars, if approved, could increase competition and further depress prices.
- Patent Litigation: Although unlikely given the age of the drug, any patent disputes or exclusivity extensions could temporarily affect market dynamics.
Key Takeaways
- NDC 62135-0817 (Simvastatin 20 mg) remains a highly affordable, widely prescribed generic, with stable demand in hyperlipidemia management.
- Current pricing is around $0.07–$0.10 per tablet, with ongoing trends pointing toward further price erosion driven by generics competition.
- The market outlook suggests minimal price increase; prices are expected to stabilize or decline modestly over the next 3–5 years.
- Stakeholders should monitor evolving formulary preferences, regulatory changes, and potential entry of new competitors, which could influence future pricing patterns.
- Cost containment remains a priority for payers, keeping generic simvastatin a central component of lipid-lowering therapy cost strategies.
FAQs
1. Will the price of NDC 62135-0817 increase due to regulatory changes?
Unlikely. Regulatory standards tend to add compliance costs but also promote manufacturing efficiencies among generics, generally maintaining stable or decreasing prices.
2. How does NDC 62135-0817 compare price-wise to branded alternatives?
Generic simvastatin typically costs significantly less—up to 90% cheaper—than branded statins like Zocor, making it a preferred choice for cost-sensitive settings.
3. Are there upcoming patent challenges or exclusivities affecting this NDC?
Given its age, simvastatin’s patent protections have long expired, with minimal likelihood of current patent litigation impacting pricing.
4. What impact could biosimilar or combination therapy entries have on simvastatin’s market?
While biosimilars pertain primarily to biologics, fixed-dose combination drugs could shift prescribing patterns but are less likely to directly affect the core generic simvastatin’s pricing.
5. How should manufacturers position NDC 62135-0817 in the current market?
Focusing on manufacturing efficiencies, quality assurance, and potential value-added formulations could help sustain margins amid price competition.
Conclusion
NDC 62135-0817, representing generic simvastatin 20 mg tablets, exemplifies the highly competitive, cost-driven landscape of lipid-lowering therapies. Market stability, driven by its entrenched position, low manufacturing costs, and broad accessibility, ensures its importance in cardiometabolic management. Future pricing will likely continue its downward trend, reaffirming the vital role of generics in sustainable healthcare.
References
- FDA. Drug Approvals and Market Data. (2022–2023).
- IQVIA. Top Prescribed Lipid-Lowering Agents Report. (2022).
- Medicare and Medicaid Provider Pricing Data. (2022).
- IMS Health. Generic Market Trends. (2022–2023).
- Pharma Intelligence. Market Dynamics and Competitive Analysis Reports. (2022).
