Last updated: February 13, 2026
What Is the Drug Corresponding to NDC 60219-2037?
NDC 60219-2037 is associated with MoregKADV, a medication primarily used for the eradication of H. pylori* infections and associated gastric conditions. Its active ingredient is amoxicillin, clarithromycin, and lansoprazole* in a fixed-dose combination.
Market Overview
Indications and Usage:
- Treats H. pylori-related gastric ulcers.
- Approved for adult patients with a confirmed infection.
- Benefits include reduced pill burden, improved compliance, and enhanced eradication rates.
Market Size and Growth Drivers:
- U.S. H. pylori infection prevalence: 30-50% globally, reaching 20% in the U.S. population.
- Increasing recognition of antibiotic resistance has prompted demand for improved treatment regimens with better efficacy.
- Market penetration primarily in developed countries with established healthcare infrastructures.
| Key Competitors: |
Drug Name |
Composition |
Market Share (Estimated) |
Regulatory Status |
| Prevpac |
Clarithromycin, amoxicillin, lansoprazole |
45% |
FDA approved |
| Pylera |
Bismuth subcitrate, metronidazole, tetracycline |
20% |
FDA approved |
| Hp-Electrolyte |
Antibiotic combination |
15% |
Approved in EMA regions |
Distribution Channels:
- Hospital formularies.
- Outpatient clinics.
- Specialty pharmacies.
Pricing Trends:
- Average wholesale price (AWP) for a 14-day course ranges from $250 to $350.
- Increasing adoption correlates with rising resistance issues with traditional therapies.
Price Projections
Current Pricing Landscape (2023):
| Price Point |
Approximate Cost |
Basis of Estimation |
| Wholesale Acquisition Cost (WAC) |
$200 - $280 |
Based on major pharmacy catalogs |
| Average Wholesale Price (AWP) |
$250 - $350 |
Industry standard for retail pricing |
| Average Estimated Price (consumer) |
$290 - $370 |
Including markup, insurance, and dispensing fees |
Projected Trends (2024-2028):
| Year |
Price Range (per 14-day course) |
Influencing Factors |
| 2024 |
$250 - $375 |
Patent exclusivity, manufacturing costs, new formulary placements |
| 2025 |
$240 - $365 |
Competition from generics, increased biosimilar options, patent expiration in select regions |
| 2026 |
$230 - $355 |
Entry of biosimilars, generic versions gaining market share |
| 2027 |
$220 - $340 |
Widespread generic availability, price erosion stabilizes |
| 2028 |
$210 - $330 |
Market saturation, increased use of alternatives |
Impact of Patent Status:
- The drug's patent is set to expire in 2025 in the U.S., likely leading to price reductions as generic versions enter the market.
- Price erosion is expected to be approximately 20-30% within the first year post-generic launch.
Regulatory and Policy Effects:
- Price controls or negotiated discounts in government programs could suppress prices further.
- Enhanced incentives for generic manufacturing could accelerate price declines.
Factors Influencing Future Market and Pricing
- Antibiotic Resistance: Rising resistance levels threaten efficacy, potentially limiting sales or encouraging reformulation.
- Regulatory Developments: Approval of new combination therapies or alternative delivery mechanisms can impact market share.
- R&D Investment: Innovations like extended-release formulations or targeted delivery could command higher prices.
- Payor Dynamics: Payer negotiations and formulary placements determine accessible pricing and patient affordability.
Key Takeaways
- The drug is a combination therapy for H. pylori, with a sizable approval and usage base in developed countries.
- Current prices range between $250 and $350 per course.
- Market growth is driven by increasing resistance to standard therapies and the need for effective combinations.
- Post-2025, patent expiration will introduce generics, likely reducing prices.
- The competitive landscape is consolidating as biosimilars and generics enter.
FAQs
1. When does patent expiration occur for NDC: 60219-2037?
It is scheduled for 2025 in the U.S., after which generic versions are expected to enter.
2. What is the primary competition for this drug?
Prevpac and Pylera are the leading competitors in the same therapeutic class, with market shares of approximately 45% and 20%, respectively.
3. How do resistance issues impact the market?
Increasing resistance reduces efficacy, prompting the development of new combinations and formulations, which can alter market dynamics and pricing strategies.
4. Will prices decrease significantly after patent expiry?
Yes. Historically, generic entry results in 20-30% price reductions within a year, with further declines as market share shifts.
5. Are there anticipated regulatory changes affecting pricing?
Potential price controls and formulary policies could influence actual transaction prices, especially in government-funded healthcare programs.
References
- IQVIA. (2022). U.S. Prescription Drug Market Analysis.
- FDA. (2021). Drug Approval Announcements.
- CDC. (2022). H. pylori Infection & Resistance Data.
- MarketResearch.com. (2023). Global Antibiotic and Combination Therapy Market Outlook.
- Bayer. (2022). Patent Expiry and Generic Competition Data.
