Last updated: February 26, 2026
What is the drug associated with NDC 68968-5552?
NDC 68968-5552 corresponds to Refresher (Active Ingredient: Sildenafil Citrate), approved for the treatment of erectile dysfunction. It is marketed as a generic alternative to branded sildenafil products.
Market Overview
Market Size and Demand
- The global erectile dysfunction market was valued at approximately USD 4 billion in 2022.
- It is expected to grow at a compound annual growth rate (CAGR) of 5.2% through 2027, driven by aging populations and increased awareness.
- The U.S. accounts for roughly 40% of global sales, with an estimated 30 million men affected.
- Generic sildenafil options occupy an estimated 70% share of the U.S. market, due to cost advantages over branded products like Viagra.
Competitive Landscape
- Key competitors include Pfizer's Viagra, Eli Lilly's Cialis, and other generics.
- As of 2022, more than 10 manufacturers produce sildenafil generics, with additional entrants expected.
- Price competition is intense; generic prices vary significantly based on formulation, packaging, and pharmacy.
Price Analysis
Historical Pricing Trends
| Year |
Average Wholesale Price per 100 mg tablet |
Notes |
| 2019 |
USD 8.50 |
Widely available as generic. |
| 2020 |
USD 7.75 |
Slight reduction amid increased market entries. |
| 2021 |
USD 6.50 |
Price pressure from increased competition. |
| 2022 |
USD 5.85 |
Further decline observed. |
Current Pricing (as of Q1 2023)
- Average retail price for 100 mg sildenafil tablets ranges from USD 4.20 to USD 6.00.
- Wholesale acquisition cost (WAC) is approximately USD 3.50 per 100 mg tablet.
- Discounted prices for cash-paying patients can be as low as USD 2.50 per tablet in some pharmacies.
Price Projections (Next 3 Years)
| Year |
Predicted Average Price per 100 mg Tablet |
Assumptions |
| 2023 |
USD 4.20 - USD 5.25 |
Market remains competitive; new generic entrants maintain price pressure. |
| 2024 |
USD 3.75 - USD 4.75 |
Further increases in generic competition may lower prices, especially with patent expiry in 2024. |
| 2025 |
USD 3.50 - USD 4.50 |
Stabilization expected; potential for slight price increases due to supply chain costs. |
Factors Influencing Price
- Entry of new generic manufacturers increases price competition.
- Changes in raw material costs, especially active pharmaceutical ingredient (API) supplies.
- Regulatory policies on drug pricing and reimbursement.
- Market demand shifts owing to increased acceptance of generic sildenafil.
- Patent expirations on brand-name competitors create space for price reductions.
Regulatory and Patent Landscape
- The original patent for Viagra expired in December 2017, enabling generics like NDC 68968-5552.
- Generic approval was granted by the FDA in 2018.
- Patent disputes or exclusivity periods could influence pricing dynamics temporarily.
Market Entry Barriers and Opportunities
- Barriers include regulatory approval timeframes, manufacturing scale, and distribution channels.
- Opportunities exist in emerging markets with increasing erectile dysfunction awareness.
- Partnering with pharmacy benefit managers (PBMs) can expand reach.
Key Takeaways
- The drug is a generic sildenafil citrate, competing mainly on price.
- The U.S. market is mature, with significant price erosion since patent expiry.
- Price projections suggest continued decline or stabilization around USD 3.50–4.50 per 100 mg tablet.
- Future market growth depends on regulatory changes, patent litigation, and healthcare policies.
FAQs
1. How will patent expirations affect the pricing of sildenafil generics?
Patent expirations open markets to multiple generic manufacturers, increasing competition and typically driving prices down. The key patent for Viagra expired in 2017, facilitating entry.
2. What are the main factors that could cause price increases in the future?
Supply chain disruptions, raw material costs, regulatory constraints, or new patent protections could lead to price increases.
3. Are there regional differences in pricing?
Yes. Prices tend to be lower in emerging markets due to competition and local policies, whereas prices in the U.S. are higher but declining.
4. What impact could new formulations or delivery methods have on price?
Innovations such as long-acting formulations or oral disintegrating tablets could command premium prices, but currently, the market favors low-cost generics.
5. How does the presence of multiple competitors influence market pricing?
High competition leads to price compression, pushing prices toward marginal costs. Market saturation limits significant price hikes.
Sources:
- Grand View Research. (2022). Erectile Dysfunction Drugs Market Size, Share & Trends Analysis.
- IQVIA. (2022). U.S. Pharmaceutical Market Data.
- U.S. Food and Drug Administration (FDA). (2018). Generic Drug Approvals and Market Entry.
- Statista. (2022). Erectile Dysfunction Drug Market Revenue.
[1] Grand View Research (2022). Erectile Dysfunction Drugs Market Size, Share & Trends Analysis.
