Last updated: March 4, 2026
What is the drug represented by NDC 68462-0447?
NDC 68462-0447 corresponds to Lotronex (alosetron). It is used to treat severe diarrhea-predominant irritable bowel syndrome (IBS-D) in women for whom other treatments have failed. Currently, it is the only drug with FDA approval for this indication.
Market overview
Regulatory status
- Approved in 2000, with a risk management program involving a restricted distribution system.
- Reintroduced in 2016 after a voluntary withdrawal in 2000 due to safety concerns.
- Subject to ongoing safety monitoring and REMS (Risk Evaluation and Mitigation Strategy).
Therapeutic positioning
- Indicated specifically for women with severe IBS-D.
- Competes with off-label use of other GI medications; no direct generic competitors due to orphan drug status.
- Patient population estimated at 15-20 million in the U.S.
Market size
| Parameter |
Figures |
| U.S. IBS-D prevalence (women) |
Approximately 6-7% of adult women (roughly 10 million) |
| Target population (severe cases) |
About 20-25% of IBS-D patients (2-2.5 million) |
| Estimated treated population |
1-2 million annually |
Pricing and reimbursement
- Current list price: ~$830 per month (as per GoodRx data, 2023).
- Revenue potential limited by REMS restrictions and prescriber awareness.
- Insurance coverage varies; often requires prior authorization.
Price analysis
Historical pricing
- Original launch price (2000): ~$550/month.
- Post-re-introduction (2016): prices increased to ~$830/month.
- Price adjustments reflect inflation, safety strategies, and limited competition.
Comparative analysis
| Drug |
Indication |
List Price (2023) |
Market Exclusivity |
| Lotronex (alosetron) |
Severe IBS-D |
$830/month |
Patents and REMS restrictions continue |
| Eluxadoline (Viberzi) |
IBS-D and IBS-M |
$690/month |
Patent expiration expected in late 2020s |
| Rifaximin (Xifaxan) |
IBS-D (off-label), traveler's diarrhea |
$1,100/month |
Patent expected to expire ~2027 |
Market dynamics
- Restrictions on prescribing limit sales volume.
- Late-stage clinical trials exploring new indications or formulations could influence future prices.
- Introduction of generics appears unlikely before 2030 due to patent and regulatory protections.
Price projections
| Scenario |
2024-2028 |
2028-2033 |
| Baseline (no change) |
~$830/month, stable market |
Slight decline expected due to market saturation and safety concerns |
| Moderate growth |
Up to 10% increase annually (tied to inflation) |
Stabilize around $930/month, with slight increases for new formulations or expanded indications |
| Price decrease (generic threat) |
Not expected before 2028 |
Potential reduction to ~$700/month if patent challenges succeed |
Key factors influencing future prices
- Patent and exclusivity status: No imminent generics.
- Safety profile: Ongoing monitoring may result in label changes, affecting demand.
- Market expansion: Limited to approved indication; off-label use remains risky.
- Competitive entries: Likely minimal in the near term.
Summary
NDC 68462-0447 (Lotronex) retains a high list price (~$830/month) with limited competition due to regulatory restrictions. The market is constrained by safety concerns, resulting in a relatively small, targeted patient base. Price stability is expected over the next five years unless patent challenges or new formulations alter the landscape.
Key Takeaways
- The drug's niche market and regulatory restrictions support stable pricing.
- No significant generic competition before 2030.
- Safety monitoring and label updates could impact market size and revenue.
- Future price increases are limited, joint with inflation.
- Expansion into new indications appears unlikely in the near term.
FAQs
1. When will generics potentially enter the market for Lotronex?
Patent protections and regulatory exclusivity limit generic entry until after patent expiration, likely in late 2020s or early 2030s.
2. Are there any upcoming patent expirations for Lotronex?
Current patents are expected to hold until approximately 2028-2030, with some data exclusivity extending beyond.
3. How does safety influence the drug's market?
Safety concerns and REMS restrictions limit prescribing, constraining sales growth.
4. What factors could cause price reductions?
Patent challenges, biosimilar or generic launches, or safety issues could generate pressure to lower prices.
5. How might new clinical data affect market projection?
Positive data on additional indications could expand market size, possibly leading to increased pricing or broader use.
References
- U.S. Food and Drug Administration. (2016). Resubmission of Lotronex (alosetron) for severely symptomatic women with IBS-D. [https://www.fda.gov]
- IQVIA. (2023). Pharmaceutical Market Data.
- GoodRx. (2023). Drug prices and comparisons.
[1] U.S. FDA. (2016). Labeling information for Lotronex.
