Last updated: March 9, 2026
What is NDC 46122-0441?
NDC 46122-0441 refers to a specific pharmaceutical product listed in the National Drug Code database. This code corresponds to Sildenafil Tablets, 100 mg, marketed primarily for the treatment of erectile dysfunction (ED).
Market Size and Trends
Current Market Size
The global erectile dysfunction market was valued at approximately $4.0 billion in 2022. The U.S. accounts for a significant portion, estimated at $1.8 billion in 2022, driven by high prevalence of ED and established treatment protocols.
Prevalence and Demand
- ED affects about 30 million men in the United States.
- The market primarily includes branded drugs such as Viagra (Pfizer) and Cialis (Eli Lilly), with over-the-counter options limited or unavailable.
- Generic versions of sildenafil, including NDC 46122-0441, have gained substantial market share since patent expirations.
Competitive Landscape
| Product Name |
Manufacturer |
Price per 100 mg Tablet (USD) |
Market Share (2022) |
Notes |
| Viagra |
Pfizer |
$90 |
60% |
Branded, high marketing spend |
| Sildenafil (generic) |
Various generics |
$10-$20 |
30% |
Cost advantage over branded products |
| Cialis |
Eli Lilly |
$25-$35 |
7% |
Longer duration, different brand |
Key Competitors
- Pfizer's Viagra, still the market leader for ED treatment.
- Multiple manufacturers produce sildenafil generics, driven by patent expiry in 2013.
- Price competition significantly impacts market share retention.
Regulatory Environment
- Patent expiration in 2013 led to increased generic competition.
- The FDA approves multiple generic sildenafil products following Abbreviated New Drug Application (ANDA) processes.
- No recent patent litigations or regulatory delays for sildenafil generics reported.
Price Projection Analysis
Current Pricing
- Generic sildenafil 100 mg tablets average $10-$20 per 30-tablet pack, translating to roughly $0.33-$0.67 per tablet.
- Branded Viagra remains significantly more expensive at $90 per 100 mg tablet.
Short-term Trends (1-2 Years)
- No significant price changes expected due to supply chain stability and ongoing generic competition.
- Price consolidation may occur if major manufacturers reduce prices to gain market share.
Long-term Trends (3-5 Years)
- Prices for sildenafil generics are likely to stabilize or decline slightly, with average prices around $8-$15 per 100 mg tablet.
- Market saturation may lead to further price reductions, especially with increased online distribution channels.
Impact of Policy and Innovation
- No recent policy changes expected to alter pricing.
- Potential for biosimilar or alternative formulations to offer competitive pricing but unlikely for small-molecule generics like sildenafil.
Price Projections Summary
| Year |
Estimated Price per 100 mg Tablet (USD) |
Assumptions |
| 2023 |
$10-$20 |
Established generic competition, stable demand |
| 2024 |
$8-$18 |
Mild price declines, no disruptive factors |
| 2025 |
$8-$15 |
Market saturation, online channels strengthen |
| 2026 |
$8-$15 |
Continued stabilization, minimal innovation |
Key Factors Influencing Future Prices
- Patent expirations for additional formulations.
- Entry of biosimilar or alternative ED treatments.
- Shifts in healthcare policy affecting drug pricing.
- Manufacturing costs and supply chain efficiency.
Key Takeaways
- NDC 46122-0441 (sildenafil 100 mg) faces a competitive market dominated by generics.
- Prices are currently in the range of $10-$20 per 100 mg tablet.
- Market share trends favor generics, suggesting stable or declining prices in the near to mid-term.
- Long-term projections indicate modest declines or stabilization, barring major policy or technological changes.
- Competitive pressure and patent landscape significantly influence pricing dynamics.
FAQs
1. What factors most impact the price of sildenafil generics like NDC 46122-0441?
Market competition, patent expirations, regulatory changes, and manufacturing costs.
2. Are there upcoming patent expirations for sildenafil products?
The primary patents expired in 2013, leading to widespread generic availability.
3. How does the price of NDC 46122-0441 compare to branded Viagra?
Generic sildenafil costs approximately $10-$20 per 100 mg tablet, versus $90 for branded Viagra.
4. Will price reductions continue for sildenafil generics?
Likely, unless supply chain disruptions or new formulations alter the competitive landscape.
5. What regulatory factors could affect future pricing?
Policy changes on drug pricing, approval of biosimilars, or patent litigations can influence prices.
References
[1] Grand View Research. (2023). Erectile Dysfunction Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration (FDA). (2022). ANDA Approvals and Patent Date Listings.
[3] IQVIA. (2022). The Impact of Generic Competition on ED Treatment Market.
[4] Statista. (2022). U.S. Market Revenue for Erectile Dysfunction Drugs.
[5] Health Canada. (2022). Regulation and Approval of Sildenafil Products.
