Last updated: July 27, 2025
Overview of NDC 00046-1102
NDC 00046-1102 corresponds to Lansoprazole delayed-release capsules, commonly marketed as Prevacid. Lansoprazole is a proton pump inhibitor (PPI) widely used for gastroesophageal reflux disease (GERD), peptic ulcer disease, and related gastrointestinal conditions. Its therapeutic profile positions it as a pivotal medication within the acid suppression drug class, with substantial market presence across both prescription and over-the-counter segments.
Market Landscape
Therapeutic Area and Market Demand
Lansoprazole's role in managing acid-related disorders sustains consistent demand. The drug’s widespread prescription, coupled with its over-the-counter (OTC) formulations, contributes to its extensive market footprint. In 2022, the global PPI market was valued at approximately USD 12.5 billion, with Lansoprazole accounting for a significant portion [1].
Demand drivers include:
- Prevalence of GERD and Peptic Ulcers: Over 30% of Western populations experience acid reflux symptoms annually, underpinning stable prescription volumes.
- Chronic Use Patterns: Long-term management of acid-related conditions ensures recurrent demand.
- OTC Accessibility: Availability as an OTC medication expands consumer accessibility, broadening the payer and distribution landscape.
Competitive Landscape
Lansoprazole faces intense competition from other PPIs like omeprazole, esomeprazole, pantoprazole, and rabeprazole. Market share is distributed among branded formulations (e.g., Prevacid) and generics, with generics accounting for the majority of prescriptions due to affordability and insurance formulary preferences.
Key competitive dynamics include:
- Generic Penetration: The availability of multiple generic versions has driven prices downward and increased market penetration.
- Patent Expirations: The primary patent exclusivity for Prevacid expired in 2012, facilitating a robust generic market.
- Emergence of New Therapies: Novel PPI formulations with improved efficacy or safety profiles are gradually entering the market, subtly impacting Lansoprazole’s market share.
Regulatory and Patent Status
- Patent Status: The original patents for Prevacid expired in 2012, leading to widespread generic competition [2].
- Regulatory Approvals: Lansoprazole is approved by the U.S. Food and Drug Administration (FDA) for prescription use and OTC availability, contributing to its wide distribution.
Pricing Dynamics and Projections
Current Price Landscape
The price of NDC 00046-1102 disparately varies depending on formulations, dosage strengths, and distribution channels:
- Brand-Name Prevacid: Typically ranges between USD 250–400 for a 30-capsule bottle.
- Generic Versions: Prices are significantly lower, often around USD 20–50 for a comparable supply, driven by intense generic competition.
- OTC Pricing: OTC versions retail for approximately USD 15–30 for a 14- to 42-count bottle, depending on retailer and location.
Factors Influencing Future Pricing
- Market Saturation: High generic penetration suggests continued price erosion unless new formulations or indications emerge.
- Drug Library Inclusion: Insurance formularies increasingly favor generic PPIs, pressuring brand prices downward.
- Manufacturing Costs: Advances in manufacturing efficiency and patent expirations promote lower costs.
- Regulatory Changes: Potential patent litigation or new regulatory filings (e.g., for novel delivery systems) could influence pricing dynamics.
Price Projection (Next 5 Years)
Based on industry trends, competitive landscape, and healthcare reimbursement policies, the following projections are anticipated:
| Year |
Estimated Price Range for Generics (per 30 capsules) |
Notes |
| 2023 |
USD 20–50 |
Current market, widespread generic availability |
| 2024–2025 |
USD 18–45 |
Continued price pressure, potential new generic entrants |
| 2026–2027 |
USD 15–40 |
Market stabilization, increased OTC sales influence |
| 2028–2029 |
USD 12–35 |
Further cost reductions, possible formulations innovation |
Note: Brand-name Prevacid may retain premium pricing but likely will diminish further due to generic competition, potentially stabilizing around USD 250–350 per bottle depending on supply chain and demand dynamics.
Market Opportunities and Challenges
Opportunities
- Expansion into Emerging Markets: Growing healthcare infrastructure and increasing gastroenterological disorder prevalence offer expansion prospects.
- Innovative Formulations: Development of OTC or combination therapies could command premium pricing.
- Value-Based Pricing Models: As healthcare shifts toward value-based care, demonstrations of cost-effectiveness could justify maintained or increased price points.
Challenges
- Generic Competition: Intense price competition constrains margins.
- Regulatory Risks: Patent litigations or regulatory hurdles could delay or restrict new formulations.
- Market Saturation: Mature markets limit growth prospects, necessitating strategic diversification.
Consolidated Summary and Business Implications
The landscape for NDC 00046-1102 remains highly competitive and price-sensitive. Widespread availability of generics exerts downward pressure on prices, while the persistent demand for acid suppression therapies sustains volume. Companies looking to optimize revenue should consider investing in differentiated formulations, exploring new indications, or expanding geographically into emerging markets. Patents for the original formulation have long expired, emphasizing the importance of innovation to command premium pricing.
Key Takeaways
- Lansoprazole (NDC 00046-1102) enjoys broad market demand driven by the high prevalence of GI disorders and its established safety profile.
- The market is saturated with generics, leading to sustained price declines and limited growth potential for branded drugs.
- Price projections indicate continued downward pressure with generics expected to stabilize around USD 12–40 per 30-capsule supply in the coming years.
- Strategic opportunities lie in developing innovative formulations, expanding into new markets, and leveraging regulatory advantages for novel indications.
- Industry stakeholders must monitor patent statuses, regulatory developments, and competitive actions to adapt pricing and revenue strategies effectively.
FAQs
Q1: What factors most significantly impact the price of Lansoprazole (NDC 00046-1102)?
A: Patent status, generic competition, healthcare policy changes, manufacturing costs, and market demand primarily influence pricing.
Q2: Is there potential for introducing a new formulation of Lansoprazole in the near future?
A: While innovation can provide differentiation, market saturation and generic pressure pose challenges. Success depends on regulatory approval, clinical advantages, and market acceptance.
Q3: How does OTC availability affect the prescription market for Lansoprazole?
A: OTC access broadens the consumer base, reduces prescription volume, and exerts downward pressure on prescription prices but can increase overall market penetration.
Q4: What are the growth prospects for Lansoprazole in emerging markets?
A: Growing healthcare infrastructure and rising prevalence of GI disorders support expansion, often at lower pricing levels but with volume-driven revenue potential.
Q5: What strategic approaches should pharmaceutical companies consider regarding Lansoprazole?
A: Focus on developing innovative or combination therapies, expanding patent protections through formulation patents, and targeting underserved markets.
References
[1] Grand View Research. Proton Pump Inhibitors Market Size & Trends. 2022.
[2] U.S. Patent and Trademark Office. Patent Status for Prevacid. 2012.
