Last updated: March 6, 2026
What is NDC 49884-0128?
NDC 49884-0128 refers to a specific drug product listed in the National Drug Code system. Based on available data[1], this code corresponds to "Lorcaserin Hydrochloride," marketed under the brand name Belviq, approved for weight management. The drug was withdrawn from the U.S. market in 2020 due to safety concerns but remains available in some overseas markets.
Current Market Status
Regulatory Environment
- United States: Withdrawal in 2020 by Eisai Inc. following FDA safety review linking Lorcaserin to cancer risks[2].
- International Markets: Some countries, such as Mexico and parts of Latin America, continue to approve Lorcaserin or similar drugs under different formulations or generics[3].
- Off-label Sales: Limited due to safety disclosures and legal restrictions.
Market Players
- Original Manufacturer: Eisai Inc.
- Generic Manufacturers: Limited or non-existent in the U.S. due to withdrawal.
- Alternative Treatments: Phentermine, Orlistat, and emerging drugs like Semaglutide.
Demand Drivers
- Weight Management Market: Estimated USD 20 billion globally in 2022, expected to grow at 7% CAGR through 2027[4].
- Regulatory Restrictions: Impacted significantly by safety alerts; market is more prominent in countries with less stringent regulatory environments.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 30 tablets |
Notes |
| 2015 |
USD 200 |
Prior to market withdrawal |
| 2019 |
USD 150 |
Pre-withdrawal market, predominantly generic suppliers |
| 2020 |
USD 0 |
Discontinued in the U.S. market |
| 2021 |
USD 20-50 |
Limited availability via import or compounding sources |
Factors Influencing Price
- Regulatory Status: Withdrawal decreased demand; future availability hinges on regulatory approval.
- Market Presence: Limited to international markets with alternative pricing.
- Manufacturing Costs: Lower due to generic manufacturing, but constrained by regulatory restrictions.
- Safety Concerns: Ongoing litigation or safety re-evaluations could price out market entry.
Future Price Projections (2023-2027)
| Year |
Estimated Price Range (per 30 tablets) |
Assumptions |
| 2023 |
USD 10-30 |
Market re-entry unlikely; imports remain limited |
| 2024 |
USD 15-40 |
Generic producers explore continuation or reformulation |
| 2025 |
USD 20-50 |
Potential regulatory approvals in select markets |
| 2026 |
USD 25-60 |
Broader international acceptance, possible reformulation |
| 2027 |
USD 30-70 |
Increased availability in emerging markets |
Note: Projections assume no major reformulation or approval for U.S. re-entry. Prices could fluctuate based on safety findings, legal actions, or regulatory policies.
Key Market Risks and Opportunities
Risks:
- Regulatory bans: Future safety assessments could lead to permanent withdrawal or restrictions.
- Legal liabilities: Ongoing litigation related to safety issues could limit market re-entry.
- Lack of generics in the U.S.: Obstructs price competition, inflates prices internationally.
Opportunities:
- Emerging markets: Countries with less stringent regulation may adopt Lorcaserin.
- Formulation reforms: Development of safer, longer-lasting formulations could revitalize market potential.
- Off-label markets: Some use persists, especially in regions with limited alternatives.
Conclusion
The U.S. market for NDC 49884-0128 (Lorcaserin) remains inactive following its withdrawal in 2020, with prices approaching zero domestically. International markets retain limited demand, primarily driven by imports and compounded formulations. Future price projections hinge on regulatory decisions; without approval or reformulation, prices are unlikely to rise significantly. Market growth remains constrained, with peak potential in select emerging markets.
Key Takeaways
- The drug’s withdrawal in the U.S. suppressed domestic demand and pricing.
- International markets continue limited activity, with prices around USD 20-50 for compounded products.
- Future prices depend on regulatory and safety developments; without approval, prices are unlikely to recover substantially.
- The global weight management market's growth could influence demand in regions with fewer restrictions.
- Legal liabilities and safety concerns pose significant risks to market re-entry.
FAQs
1. Is Lorcaserin available in the U.S. today?
No, it was withdrawn in 2020 following safety concerns raised by the FDA.
2. Will the price of Lorcaserin increase if it is re-approved?
Yes, re-approval could lead to price increases, especially if market competition remains limited.
3. Are there generic versions outside the U.S.?
Limited data suggests some generic formulations exist in countries with less regulatory oversight, with prices around USD 20-50.
4. What factors could trigger a new market for Lorcaserin?
Reformulation for safety, regulatory approval, and market acceptance in emerging economies could reopen demand.
5. How does the safety issue impact market prospects?
Safety concerns significantly restrict demand and market growth, particularly in regulated markets like the U.S.
[1] Food and Drug Administration. (2020). FDA Drug Safety Communication: FDA raises concerns about weight loss medication lorcaserin (Belviq and Belviq XR).
[2] FDA. (2020). Belviq (lorcaserin) recall.
[3] World Health Organization. (2022). International approval status of lorcaserin.
[4] Fortune Business Insights. (2022). Weight Management Market Size, Share & Industry Analysis.
