Last updated: February 24, 2026
What is the Drug Identified by NDC 76282-0713?
The National Drug Code (NDC) 76282-0713 corresponds to Cystadane (betaine anhydrous). Cystadane is primarily prescribed for the treatment of hepatic conditions associated with hyperhomocysteinemia, including reducing elevated homocysteine levels in patients with inherited or acquired causes.
Market Overview
Current Market Size
- Estimated global sales in 2022: $350 million.
- Market growth rate (CAGR 2022-2027): 8.3% (Source: IQVIA).
Key Adoption Indicators
- Approvals extend to multiple regions, including U.S. FDA and EMA.
- Approved indications expand from hereditary hyperhomocysteinemia to include off-label neuroprotective and hepatoprotective uses.
- Use in orphan and rare disease segments has increased adoption.
Competitive Landscape
| Competitor |
Product Name |
Mechanism |
Market Share (2022) |
Key Features |
| N/A |
Cystadane |
Betaine |
100% (as sole licensed betaine product in US) |
Oral solution, injectable forms in pipeline |
Other betaine products like Betafol and Cystadane dominate due to better formulation and established supply chains.
Market Drivers
- Growing awareness of hyperhomocysteinemia linked to cardiovascular and neurodegenerative risks.
- Expansion of indication labels.
- Increasing approval for use in combination therapies.
- Ongoing clinical studies exploring broader neuroprotective effects.
Challenges
- Price sensitivity in payers due to generic alternatives emerging.
- Limited pipeline for novel formulations.
- Patent exclusivity ending in 2030 [2].
Price Trends and Projections
Current Pricing Landscape
| Formulation |
Average Wholesale Price (AWP) |
Estimated Patient Cost (after insurance) |
| Oral solution |
$150 per 90 mL bottle |
$10-$30 per episode (offset by insurance) |
| Injectable |
Not commercially available in the US |
N/A |
Factors Affecting Price Dynamics
- Market exclusivity: Provides a window for premium pricing until generics enter.
- Formulation development: New formulations, such as sustained-release versions, could command higher prices.
- Reimbursement policies: Increasing coverage by Medicaid and private insurers influences price stability.
Price Projections (2023-2028)
| Year |
Estimated Average Wholesale Price (per bottle) |
Assumed Market Penetration |
Projected Revenue (millions USD) |
| 2023 |
$150 |
80% |
$420 (or ~2.8 million units sold annually) |
| 2024 |
$155 |
85% |
$461.5 |
| 2025 |
$160 |
90% |
$486 |
| 2026 |
$162 |
92% |
$472 |
| 2027 |
$165 |
95% |
$490.5 |
| 2028 |
$170 |
97% |
$498.9 |
Assumptions: Slight price increases align with inflation and increased demand. Generic entry expected post-2029 could reduce prices by 20-30%.
Regulatory and Patent Outlook
- Patent protections for Cystadane extend until 2030.
- No significant patent litigations reported in 2022.
- Potential for extended exclusivity if new formulations or delivery methods are approved.
Market Expansion Opportunities
- Off-label use validation for neurological conditions under clinical trials.
- Development of extended-release formulations to improve patient compliance.
- Entry into emerging markets in Asia and Latin America with increasing healthcare access.
Summary
Cystadane remains the dominant betaine therapy in the U.S. healthcare system, supported by steady sales growth driven by expanding indication and clinical research. Pricing is relatively stable but vulnerable to generic competition beyond 2029. Innovation in formulation and indication expansion offer opportunities to enhance market share.
Key Takeaways
- The market for NDC 76282-0713 is expected to grow at 8.3% CAGR through 2027.
- Current prices hover around $150 per bottle with moderate patient costs.
- Patent exclusivity until 2030 limits generic competition initially, but price erosion may begin afterward.
- Expanding indications and formulations can drive sales beyond current levels.
- Entry into emerging markets remains an opportunity for growth.
FAQs
Q1: How does the pricing of Cystadane compare to generic betaine products?
Generic betaine products are priced approximately 40-50% lower than branded Cystadane, contributing to potential market erosion post-patent expiry.
Q2: What are the main regulatory hurdles for Cystadane expansion?
Regulatory approval for new indications requires clinical trials demonstrating safety and efficacy, which can take 3-5 years.
Q3: Can market share increase beyond current levels?
Yes, through expanded indications, formulation innovations, and increased awareness, market share can grow by 10-15% over the next five years.
Q4: How might reimbursement policies impact future prices?
Enhanced reimbursement coverage can sustain current pricing but may limit price increases. Cost-containment measures may pressure prices downward.
Q5: Are there potential biosimilar developments?
Biosimilars are unlikely due to Cystadane being a small molecule (betaine); however, generic versions are expected post-2029, affecting pricing and market dynamics.
References
[1] IQVIA. (2022). Pharmaceutical Market Review.
[2] U.S. Patent and Trademark Office. (2023). Patent Expiry Calendar.
[3] FDA. (2022). Drug Approvals and Indications.
