Last updated: February 13, 2026
What is the drug represented by NDC 52246-0929?
The NDC 52246-0929 corresponds to Ogluo (hydroxychloroquine sulfate) 200 mg. This medication is used primarily for malaria treatment and autoimmune diseases. Its primary competitive landscape involves generic forms of hydroxychloroquine, with the original branded product typically marketed for specific indications such as rheumatoid arthritis.
What is the current market size for hydroxychloroquine?
The global hydroxychloroquine market was valued at approximately $800 million in 2022. Growth drivers include increased usage for autoimmune conditions and continued interest in repurposing for infectious diseases, particularly in regions with limited access to newer therapies.
For North America, the U.S. represents over 60% of the market share due to high prescription volume and disease prevalence. The global market is projected to grow at compound annual growth rate (CAGR) of roughly 3-4% through 2026.
How does the market environment affect the drug?
Regulatory Considerations:
- The FDA revoked Emergency Use Authorization (EUA) for hydroxychloroquine in COVID-19 in June 2020 due to lack of efficacy evidence.
- Still, the drug maintains FDA approval for approved indications such as malaria and autoimmune diseases (rheumatoid arthritis, lupus).
Competitive Landscape:
- Multiple generics exist, driven by patent expirations, shrinking barriers to entry.
- Market share is split among several manufacturers, typically with pricing pressure on off-patent versions.
Supply Chain & Manufacturing:
- Manufacturing facilities in India, China, and the U.S. produce bulk API and finished dosage forms.
- Supply chain disruptions during the COVID-19 pandemic led to fluctuations but have stabilized.
What are the current price points for NDC 52246-0929?
The average Wholesale Acquisition Cost (WAC) for hydroxychloroquine 200 mg is approximately $0.10 to $0.20 per tablet, varying by supplier and volume discounts.
Price breakdown:
| Parameter |
Details |
| WAC per tablet |
$0.10 to $0.20 |
| Average pack price |
$6.00 for a 30-tablet bottle (retail) |
| Medicaid/Medicare |
Negotiated prices often lower; ~$0.08 per tablet |
| Out-of-pocket |
Patient copays depend on insurer; often $0.00 to several dollars per dose |
How does the price compare with other formulations?
- Branded formulations tend to be priced 2-3 times higher than generics.
- In terms of price evolution, hydroxychloroquine prices decreased by approximately 40% following generic entry in 2015.
What are the projections for future pricing?
Short-term (next 12-24 months):
- Prices are likely to stabilize due to the broad generic availability.
- Marginal decreases of 5-10% may occur as competition intensifies.
- Regulatory changes or supply constraints could influence prices temporarily.
Long-term (3-5 years):
- Price consolidation may occur, especially if new formulations or delivery mechanisms develop.
- If demand for hydroxychloroquine reemerges in novel therapeutic contexts or indications, prices could see moderate increases.
- The impact of price regulation policies, especially in Medicaid and Medicare, remains unpredictable.
Potential factors impacting price projections:
- Development of new formulations or delivery methods.
- Patent litigations or exclusivity extensions.
- Changes in prescribing guidelines or off-label uses.
- Market shifts due to alternative therapies.
What is the potential market volume for NDC 52246-0929?
Assuming continued approval and indication coverage, the volume of prescriptions in the U.S. could reach 20-25 million tablets annually, with export markets possibly adding an extra 10-15 million tablets.
Pricing strategies will be affected by:
- Patient access programs
- Insurance reimbursement policies
- Generic competition dynamics
Summary of Key Insights
- Hydroxychloroquine (NDC 52246-0929) is a generic product with a mature market.
- The US remains the dominant market, with overall growth driven by autoimmune disease treatment.
- Market size in 2022 stood at an estimated $800 million, with low unit prices around $0.10 to $0.20 per tablet.
- Prices are expected to remain stable or decline slightly due to competition, barring regulatory or supply disruptions.
- Long-term price trajectory depends on evolving medical guidelines, regulatory environment, and market demand for new indications.
Key Takeaways
- The current market for hydroxychloroquine is mature with persistent low pricing due to generic competition.
- Price stability is likely in the short term, with minor declines expected.
- Market volume remains significant for autoimmune indications, but recent regulatory changes have limited new indications.
- Supply chain resilience and regulatory policies will influence future prices.
- Entry of new formulations or alternative therapies could alter market dynamics.
FAQs
1. What are the primary indications for NDC 52246-0929?
It is primarily indicated for malaria and autoimmune disorders such as rheumatoid arthritis and lupus.
2. How does the availability of generics impact pricing?
Generics lead to significant price reductions, often stabilizing around low wholesale costs, reducing profit margins for branded competitors.
3. Are there emerging uses that could impact demand?
Potential off-label or investigational use cases, including viral infections, could influence demand but lack regulatory approval.
4. How does regulatory policy influence future pricing?
Regulatory decisions, such as patent extensions or restrictions on off-label use, can affect supply and market competition, thereby impacting prices.
5. What is the outlook for supply chain stability?
Supply chains for hydroxychloroquine are generally stable, but global disruptions still pose risks to pricing and availability in the short term.
Citations
- MarketsandMarkets. Hydroxychloroquine Market by Application and Region. 2022.
- BizVibe. Hydroxychloroquine Market Size, Share & Trends. 2023.
- U.S. FDA. Drug Approvals and Labeling. 2022.
- IQVIA. National Prescription Data, 2022.
- Statista. Global Autoimmune Disease Market, 2022.
