Last updated: February 24, 2026
What is NDC 68462-0402?
NDC 68462-0402 refers to a specific drug product, which is identified by the National Drug Code (NDC). The code corresponds to a branded or generic formulation, packaging, and strength, typically used for prescription medications. Based on available databases, NDC 68462-0402 corresponds to Sildenafil Citrate Tablets, 20 mg, marketed under the brand name Viagra or as a generic equivalent.
Current Market Position
Market Size and Demand
The global erectile dysfunction (ED) treatment market size was valued at approximately USD 3.27 billion in 2021. From 2022 onward, it is projected to grow at a compound annual growth rate (CAGR) of 7.1% through 2030. The increase correlates with rising awareness, aging populations, and expanding healthcare coverage.
In the U.S., the prescription volume for sildenafil (the active ingredient) was about 7.5 million prescriptions in 2022, reflecting high brand and generic product penetration. The U.S. market accounts for roughly 60% of the global ED market, with Europe and Asia-Pacific regions demonstrating significant growth potential.
Competitive Landscape
The main competitors include:
- Pfizer's Viagra (patented until 2013; now generic)
- Generic manufacturers: Teva, Mylan, Sun Pharma, Lupin
- Alternatives: Tadalafil (Cialis), Vardenafil (Levitra)
The entry of generics led to a significant price decline in recent years.
Pricing Analysis
Historical Pricing Trends
- Brand Viagra (Pfizer): Wholesale acquisition cost (WAC) per 20 mg tablet ranged from USD 12 to USD 18 in 2012-2013.
- Generics: Post-patent expiration, prices declined sharply, with average retail prices dropping to about USD 1.50–USD 3.50 per 20 mg tablet in 2022.
Current Price Range (as of 2023)
| Product Type |
WAC per 20 mg tablet |
Average Retail Price |
Notes |
| Brand Viagra (name) |
USD 12 – USD 18 |
USD 20 – USD 30 |
With insurance or discounts |
| Generic (various brands) |
USD 1.50 – USD 3.50 |
USD 4 – USD 7 |
Widely available, significant price drop |
Factors Influencing Future Price Projections
- Patent status and exclusivity: Sildenafil's patent expired in 2013; generic competition remains strong.
- Market penetration: Continued increase in outpatient prescriptions.
- Manufacturer strategies: Price reductions to gain market share; potential entry of biosimilars or combination therapies.
- Regulatory environment: Changes affecting pricing, particularly in Medicare/Medicaid and insurance reimbursements.
- Supply chain dynamics: Raw material costs and manufacturing capacity.
Price Projections (2023-2030)
Based on current market conditions, industry trends, and the competitive landscape, the following projections are made:
| Year |
Expected WAC per 20 mg Tablet |
Notes |
| 2023 |
USD 1.50 – USD 3.50 |
Stable prices, high generic competition |
| 2025 |
USD 1.20 – USD 2.80 |
Slight downward pressure due to increased competition |
| 2027 |
USD 1.00 – USD 2.50 |
Market saturation; new entrants impact pricing |
| 2030 |
USD 0.90 – USD 2.00 |
Possible further price declines, demand stabilizes |
Note: Prices may fluctuate based on new market entrants, policy changes, or patent litigation outcomes.
Key Market Trends
- The increasing prevalence of ED among aging males supports steady demand.
- The push for cost containment in healthcare encourages use of lower-cost generics.
- Direct-to-consumer advertising remains high but is declining post-FDA restrictions.
- Pharmaceutical companies increasingly focus on combination therapies or alternative delivery methods, which could influence the standalone drug's market share.
Risks and Opportunities
Risks:
- Price erosion from rampant generic competition.
- Regulatory or patent litigation that could delay market activity.
- Reduced reimbursement rates affecting retail pricing.
Opportunities:
- Entry into emerging markets with expanding healthcare infrastructure.
- Development of novel formulations or delivery systems.
- Expansion into over-the-counter (OTC) segments.
Key Takeaways
- NDC 68462-0402 (sildenafil 20 mg) operates in a saturated, highly competitive market.
- Prices have declined markedly since patent expiration, stabilizing at low generic rates.
- Market growth driven by aging populations and increasing ED cases remains steady.
- Price projections suggest minimal further reduction over the next decade.
- Strategic focus should be on market penetration, cost efficiencies, and potential novel formulations.
FAQs
1. How does patent status affect sildenafil pricing?
The patent on Viagra expired in 2013, enabling generic manufacturers to enter the market, which significantly reduced prices and increased access.
2. What is the primary driver of demand for sildenafil?
The aging population and rising prevalence of erectile dysfunction contribute to consistent demand for sildenafil and other ED treatments.
3. Are there regulatory barriers impacting sildenafil prices?
No significant regulatory barriers currently prevent generic pricing but changes in insurance reimbursement and formulary preferences can impact retail price and market share.
4. How does the market for sildenafil compare globally?
Developed markets, such as the U.S. and Europe, exhibit high penetration; emerging markets show growth but face affordability challenges that influence pricing.
5. What future product developments could affect sildenafil’s market?
Novel delivery systems, combination therapies, or OTC availability could alter market dynamics but are not imminent at current.
References
[1] Grand View Research. (2022). Erectile Dysfunction Drugs Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Prescription Drug Market Data.
[3] U.S. Food and Drug Administration. (2013). Patent termination and generic approval records.
[4] Statista. (2023). Prescription volume and pricing data for ED drugs.
[5] MarketWatch. (2023). Price trends and forecasts for generic pharmaceutical products.
Note: Data is based on public sources, market reports, and industry analysis up to 2023.
