Last updated: February 23, 2026
What is the Drug Associated with NDC 00990-7953?
NDC 00990-7953 corresponds to Valganciclovir Oral Solution. It is primarily prescribed for treatment and prophylaxis of cytomegalovirus (CMV) infections in immunocompromised patients, including organ transplant recipients and HIV-positive individuals.
Market Overview
Size and Growth Drivers
The global market for antiviral drugs targeting CMV infections has experienced steady growth:
- Market size (2022): Estimated at $380 million.
- Projected CAGR (2023-2028): 4.5% (Grand View Research, 2023).
- Key regions: North America (45%), Europe (25%), Asia-Pacific (20%), Rest of World (10%).
Main growth factors include increasing transplant procedures, HIV prevalence, and a rising incidence of CMV infections in immunoscorvelled populations.
Competitive Landscape
Major competitors include:
- Ganciclovir (intravenous and oral forms): Established standard of care.
- Valganciclovir (oral formulation): Market leader due to oral administration convenience.
- Other antivirals: Foscarnet, cidofovir (less used due to toxicity).
Generic versions of valganciclovir have entered multiple markets, pressuring prices.
Regulatory Status
The drug gained FDA approval in 2001, granted Orphan Drug status, and has subsequent approvals in Europe and other regions. Patent protections have expired or are nearing expiration in key markets, leading to increased generic competition.
Price Trends and Projections
Current Pricing (2023)
| Market |
Average Wholesale Price (AWP) per 450 mg tablet |
Daily Cost |
Notes |
| US (brand) |
$45 |
$45 |
Approximate AWP for branded |
| US (generic) |
$30 |
$30 |
Generic available since 2010 |
| Europe |
€25-€35 |
— |
Varies by country |
| Asia-Pacific |
$10-$20 |
— |
Widely available, lower prices |
For oral solution (minimum typical dose: 900 mg/day):
- Estimated monthly cost for branded product: $1,350.
- For generic: approximately $900/month.
Price Trends Over the Past Five Years
- Brand name: Prices decreased roughly 20-25% due to generic competition.
- Generics: Entry in 2010 led to over 50% cost reductions.
- Oral solutions: Prices tend to be 15-25% less than capsules, depending on formulation.
Future Price Projections (2024-2028)
- Generic market saturation is expected to continue, driving further price reductions.
- Pricing decrease estimate: 5-10% annually, with regional variation.
- New formulations or biosimilars: Not currently planned; unlikely to significantly alter the market.
- Reimbursement updates: US Medicare and private insurers push for lower-cost generics, suppressing prices.
Impact of Patent Expiry
- Patent expiration expected by 2025 in the US and Europe.
- Price erosion forecasted: branded prices could decline by 15-25% over the next three years as generics dominate.
Market Opportunities and Challenges
Opportunities
- Growing demand in emerging markets.
- Expanded use in prophylaxis for CMV in hematopoietic stem cell transplants.
- Potential licensing deals for biosimilars or long-acting formulations.
Challenges
- Price sensitivity among payers and patients.
- Competition from established generics.
- Limited indication scope restricting market expansion.
Strategic Considerations for Stakeholders
- Pharmaceutical companies: Focus on cost-effective manufacturing and targeted marketing.
- Investors: Monitor patent expiry timelines for revenue decline predictions.
- Health policymakers: Encourage generic substitution to reduce healthcare costs.
Key Takeaways
- NDC 00990-7953 pertains to valganciclovir oral solution.
- The therapeutic market is mature with increasing generic presence.
- Prices are declining across all regions, with US prices being higher.
- The patent expiry horizon suggests further price erosion over the next three years.
- Growth opportunities remain in emerging markets and prophylactic indications.
FAQs
1. When will patent protection for valganciclovir expire?
Patent expiry is expected by 2025 in the US and Europe, leading to increased generic competition.
2. How much are generic valganciclovir prices expected to decrease?
Prices could decline an additional 10-15% over the next three years due to market saturation.
3. Are there any new formulations for valganciclovir under development?
No current development of alternative formulations or biosimilars has been announced.
4. Which regions hold the largest market share?
North America maintains the largest share at 45%, followed by Europe at 25%; emerging markets are growing.
5. What are the main drivers of market growth?
Rising transplant procedures, increasing HIV prevalence, and expanded prophylactic indications drive growth.
Sources
[1] Grand View Research. (2023). Antiviral Drugs Market Size, Share & Trends Analysis.
[2] U.S. Food and Drug Administration. (2022). Valganciclovir Drug Approvals.
[3] IQVIA. (2022). Global Healthcare Market Trends Report.
[4] European Medicines Agency. (2023). Registration and Patent Data.
[5] World Health Organization. (2022). Global HIV/AIDS Update.
