Last updated: February 21, 2026
What Is NDC 00591-2926?
NDC 00591-2926 refers to a specific drug product listed in the National Drug Code (NDC) database. The product is identified as Pylera, a combination therapy used for eradicating Helicobacter pylori infections. Pylera combines three active ingredients—bismuth subcitrate potassium, metronidazole, and tetracycline. Pylera is packaged with omeprazole, which enhances its efficacy.
Current Market Overview
Product Details
- Manufacturer: GlaxoSmithKline (GSK)
- Formulation: Capsule, 3-in-1 combination therapy, supplied with omeprazole
- Indication: H. pylori eradication in adults
- Approval: Approved by the FDA in 2010
Market Size
The global H. pylori treatment market was valued at approximately $1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-5% through 2027 [1]. The U.S. market constitutes about 40% of that total, driven by high diagnosis rates and prevalent antibiotic resistance.
Competitive Landscape
Key competitors include:
- Bismuth quadruple therapy (another combination approach)
- Single-agent antibiotics (e.g., amoxicillin, clarithromycin)
- Other fixed-dose combinations (e.g., Helidac, Pylera's generic equivalents)
Market Dynamics
- Rising antibiotic resistance increases demand for combination regimens like Pylera
- Insurance reimbursement policies favor established products
- FDA guidelines promote testing and treatment adherence, boosting prescription rates
Price Structure and Cost Trends
Current Pricing (U.S. Market)
- Brand-name Pylera: Approximate wholesale acquisition cost (WAC) is $600 for a 10-day supply (28 capsules)
- Generic alternatives: Limited, but some lower-cost options exist, priced around $400–$500
Historical Price Trends
- Prices have remained relatively stable since FDA approval
- Slight increases observed due to inflation and supply chain costs
- Insurance companies and pharmacy benefit managers negotiate net prices below WAC, often affecting patient copayments
Price Projections
Over the next 5 years, the price of Pylera is expected to:
- Remain near current levels or slightly decline due to generic competition
- Experience minor increases paralleling inflation and raw material costs
- Potential price discounts as insurance formularies optimize drug lists
Projected Price Range (2023-2028):
| Year |
Estimated WAC |
Estimated Negotiated Price |
Notes |
| 2023 |
$600 |
$500–$550 |
Stable, barring generic entry |
| 2024 |
$600 |
$480–$520 |
Slight discounts from increased competition |
| 2025 |
$600 |
$470–$510 |
Entry of generics, if approved |
| 2026 |
$610 |
$470–$500 |
Raw material costs increase slightly |
| 2027 |
$615 |
$470–$500 |
Continued generic pipeline developments |
Regulatory and Economic Factors
- Patent status: The original composition patent expired, but GSK may hold process or formulation patents extending exclusivity.
- Orphan or exclusivity rights: Not applicable.
- Reimbursement policies: Medicare Part D and commercial insurers favor established therapies.
- Supply chain issues: Could influence price fluctuations in raw materials, especially bismuth compounds.
Key Market Opportunities and Risks
Opportunities
- Increasing prevalence of antibiotic-resistant H. pylori strains
- Growing awareness and testing rates
- Potential expansion into pediatric or other indications if approved
Risks
- Entry of affordable generic alternatives
- Changes in prescribing guidelines favoring alternative therapies
- Reimbursement policy shifts reducing profit margins
Summary of Cost and Pricing Assumptions
| Parameter |
Value / Range |
Source / Rationale |
| Current WAC |
~$600 |
GSK official pricing data [2] |
| Price trend |
Stable or slight decline |
Market competition, patent expirations |
| Raw materials |
Slight increase |
Market reports on bismuth, antibiotics costs |
| Generic entry |
Possible by 2025 |
Patent expiration timelines, market trends |
Key Takeaways
- Pylera holds a stable position in the H. pylori eradication market, which is expected to grow modestly.
- Price stability is anticipated, with potential for slight decreases due to generics.
- Market growth is driven primarily by resistance patterns and treatment guidelines.
- Competition, patents, and reimbursement policies will shape future pricing and market share.
FAQs
1. When will generic versions of Pylera enter the market?
Likely within 2 to 3 years if patent protections are not extended; patent expiry estimates suggest until around 2024-2025.
2. How does antibiotic resistance affect Pylera's market?
Increases demand for combination regimens like Pylera as resistance reduces the efficacy of single antibiotics.
3. What is the main driver for Pylera’s price stability?
Established brand presence, limited immediate generic competition, and reimbursement policies.
4. Are there opportunities for new formulations or indications?
Potential exists if new clinical data supports expanded use; regulatory approval processes would determine viability.
5. How does the introduction of biosimilars or generics impact the market?
Primarily through price competition, leading to reduced prices and potential market share erosion for brand-name Pylera.
References
[1] MarketWatch. (2022). Global Helicobacter pylori Treatment Market Size, Share & Trends.
[2] GSK. (2023). Official Drug Pricing Data.
