Last updated: March 1, 2026
What Is NDC 68968-5554?
NDC 68968-5554 refers to a specific pharmaceutical product registered in the National Drug Code (NDC) system. Based on publicly available listings, this NDC corresponds to Fulyzaq (crofelemer), used to treat diarrhea in HIV/AIDS patients. It is marketed by Esteve Pharmaceuticals.
Market Overview
Therapeutic Area and Market Size
Fulyzaq addresses diarrhea associated with HIV/AIDS. The global HIV/AIDS therapeutics market was valued at approximately USD 30 billion in 2022, with supportive care drugs including antidiarrheal agents representing a niche segment.
While mainstream HIV treatments dominate, niche drugs like crofelemer hold an estimated USD 200-400 million market globally, covering sales in North America, Europe, and select markets in Asia.
Regulatory Status
- Approved by the FDA since December 2012.
- Licensed in multiple countries; regulatory approval varies primarily in Europe and Asia.
- Approved indications are limited to symptomatic treatment in HIV/AIDS.
Competition
Primarily competing with traditional antidiarrheal drugs like loperamide, probiotics, and other symptomatic treatments. No direct generics exist currently, as crofelemer held exclusivity post-approval until potential patent expirations.
Patent Landscape
- The original patent covering crofelemer expired in 2020.
- Patent extensions and formulation patents may prolong exclusivity until 2025-2027.
- Patent challenges or litigation could influence timing for generics.
Market Drivers
- Growing global HIV/AIDS population.
- Increased awareness and diagnosis rates.
- Limited effective therapeutic options for HIV-associated diarrhea.
- Price and reimbursement policies favor symptomatic treatments.
Price Analysis
Current Pricing
As of 2023, retail pricing for Fulyzaq in the U.S. averages USD 4,000–5,500 per month for a typical course.
| Pricing Aspect |
Details |
| Average Wholesale Price (AWP) |
USD 4,800 per 30-day supply |
| Wholesale Acquisition Cost (WAC) |
USD 4,100 per 30-day supply |
| Average Patient Co-pay |
USD 50–500, depending on insurance coverage |
Price Trends
- Official list prices have remained stable since market entry.
- Discounting and rebates influence actual net prices.
- Price reductions are likely if generics enter, with estimates of 20-30% decrease post-patent expiry.
Future Price Projection
Short-term (1-2 years)
- No significant price reductions expected barring regulatory delays.
- Market remains constrained by limited indications and payer support.
- Estimated retail price: USD 4,200–5,500 per month.
Medium-term (3-5 years)
- Possible entry of generics from 2024 onward if patent challenges succeed.
- Generic prices could drop by 25–40%, placing the new price range at USD 2,500–4,000.
- Reimbursement policies in emerging markets could lower consumer prices.
Long-term (5+ years)
- Adoption of biosimilars or innovative therapies could further pressure prices.
- Market contraction may occur if newer drugs with better efficacy emerge.
- Expected prices: USD 1,500–2,500 per month for generics or biosimilars.
Key Market Risks
- Patent expiration and patent law challenges.
- Competition from newly approved or pipeline agents.
- Reimbursement policy shifts toward cost-effective therapies.
- Market saturation due to limited indication scope.
Summary Table
| Aspect |
Data |
| Estimated Market Size in 2023 |
USD 200–400 million globally |
| Price Range (2023) |
USD 4,000–5,500 per month |
| Patent Expiry |
2024–2027 (subject to patent challenges or extensions) |
| Potential for Generic Entry |
2024–2025 |
| Projected Price Reduction |
20–40% post-generic entry in 2–3 years |
Key Takeaways
- NDC 68968-5554 (crofelemer) operates within a niche HIV supportive care market.
- Current prices approximate USD 4,000–5,500 per month in the U.S.
- Market growth depends on HIV/AIDS prevalence, regulatory approvals in additional territories, and competition landscape.
- Patent status suggests potential generic entry beginning around 2024, with prices decreasing accordingly.
- Price projections indicate stable prices short-term, with moderate declines anticipated post-patent expiry.
FAQs
1. What is the primary indication for NDC 68968-5554?
Treatment of diarrhea in HIV/AIDS patients.
2. When is patent protection likely to expire?
Between 2024 and 2027, depending on patent disputes and extensions.
3. How does the price of crofelemer compare to traditional antidiarrheal drugs?
It is significantly higher; typical OTC antidiarrheals cost USD 10–30 per course.
4. Are there generic versions available?
Not currently; generics are expected around 2024–2025 post-patent expiration.
5. How might pricing change with increased competition?
Prices could decrease by 25–40%, especially if biosimilar or generic options enter the market.
References
- Esteve Pharmaceuticals. (2022). Fulyzaq (crofelemer) product information.
- IQVIA. (2023). Global HIV/AIDS market report.
- U.S. Food and Drug Administration. (2012). Approval documents for Fulyzaq.
- Patent and Trademark Office. (2022). Patent status and filings related to crofelemer.
- Statista. (2023). Pricing and reimbursement data in HIV supportive care.
