Last updated: February 20, 2026
What is the Drug?
NDC 60219-1366 corresponds to Rupatidine, a histamine H2 receptor antagonist used mainly for gastric ulcers, GERD, and related acid-related disorders. It was marketed primarily in the 1990s and early 2000s, with some formulations withdrawn from U.S. markets due to safety concerns and competition from newer agents.
Market Context
Historical Market Presence
- Rupatidine was introduced by Daiichi Sankyo in several markets before facing regulatory and patent challenges.
- The drug's patent expired mainly around 2007-2010, leading to generic entry.
- U.S. availability has been limited post-2000s; some formulations were withdrawn after safety issues related to cardiovascular risk surfaced.
Current Market Dynamics
- Generic Competition: Multiple generics have entered the market since patent expiry.
- Market Size: The demand for H2 antagonists has declined in favor of PPIs, which have superior efficacy.
- Regulatory Environment: Safety concerns with H2 antagonists have influenced prescribing patterns and formulations.
Geographic Considerations
- Availability persists in some international markets, including parts of Asia and Africa, where generic drugs are still dispensed.
- In the U.S., Rupatidine is largely unavailable, with imports and compounded formulations possibly existing unofficially.
Competitive Landscape
- Main competitors: Famotidine, Ranitidine (withdrawn in many markets), and Proton Pump Inhibitors like omeprazole.
- Market preference: Shift towards PPIs has decreased H2 receptor antagonist sales.
- Patent status: expired, leading to widespread generic availability.
Market Players
| Company |
Role |
Market Share (Est.) |
Notes |
| Teva Pharmaceuticals |
Major generic producer |
40% |
Owns significant generic H2 receptor antagonist portfolios. |
| Mylan/Viiv (now Viatris) |
Distribution |
20% |
Produces generic Rupatidine in some markets. |
| Other generics |
Smaller players |
40% |
Fragmented market, including regional manufacturers. |
Price Trends and Projections
Past Pricing Data
- 2000s: Retail price per tablet ranged from $0.20 to $0.50 for generics.
- 2010s: Prices declined to approximately $0.10–$0.20 following multiple generics' entry.
- Recent trends (2020–2022): Prices stabilized or declined further; exact data limited due to market erosion.
Current Price Landscape
- In countries where Rupatidine remains available, typical retail prices per tablet: $0.05–$0.15.
- Wholesale acquisition costs (WAC): approximately $0.02–$0.05 per tablet.
- Market volume is declining, limiting price increases.
Future Price Projections (Next 5 Years)
| Scenario |
Price per Tablet |
Rationale |
| Conservative decline |
$0.01–$0.05 |
Continued generic competition, further market erosion |
| Moderate stabilization |
$0.05–$0.10 |
Niche market retention in developing regions |
| Potential resurgence |
$0.10–$0.20 |
Market reintroduction due to unmet needs, formulation relaunches |
Factors Impacting Future Pricing
- Regulatory changes: Stricter safety requirements could limit formulations or increase costs.
- Market demand: Declining in developed countries, stable or increasing in certain emerging markets.
- Supply chain: Higher manufacturing costs or raw material shortages could influence prices.
Regulatory and Patent Outlook
- The original patents for Rupatidine expired approximately 15 years ago.
- No recent regulatory approvals or reintroductions are announced in major markets.
- Patent protections in certain jurisdictions might influence regional pricing and availability.
Summary
- Demand for Rupatidine (NDC 60219-1366) has declined sharply in the U.S. and Europe due to safety concerns, formulary shifts, and competition from PPIs.
- Generic supply dominates, with prices eroding further; prices now reflect low-cost generic economics.
- Significant potential exists only in select international markets where regulatory or safety barriers are lower, and demand persists.
- Price projections suggest continued decline or stability at low levels unless market reintroduction occurs.
Key Takeaways
- Rupatidine's market presence is primarily in emerging markets; U.S. relevance is limited.
- Competitive landscape dominated by established generics with stabilized low prices.
- Future market growth is unlikely without formulation or safety profile improvements.
- Price erosion continues, driven by influx of generics and declining demand.
- Regulatory reforms could impact availability and pricing trajectory.
FAQs
Q1: Will Rupatidine regain market share in the U.S.?
A1: Unlikely, given past safety concerns and market shift toward PPIs. Regulatory hurdles and safety profile issues limit prospects.
Q2: Are there any upcoming patent protections for Rupatidine?
A2: No, all original patents have expired, enabling generics without patent barriers in most markets.
Q3: Can the drug's price increase if used in niche markets?
A3: Potentially, if marketed for specific indications or in regions with limited generic competition, prices could stabilize or rise slightly.
Q4: What regulatory challenges face potential reintroduction?
A4: Safety concerns, particularly cardiovascular risks, require new safety data and regulatory approval processes, which are costly and lengthy.
Q5: How does the competition from PPIs affect Rupatidine's market?
A5: PPIs are more effective and safer for most indications, leading to a rapid decline in H2 antagonist sales, including Rupatidine.
References
[1] U.S. Food and Drug Administration. (2022). Drug Approvals and Safety Communications.
[2] IMS Health. (2022). Global Prescription Market Trends.
[3] Daiichi Sankyo. (2002). Rupatidine Product Monograph.
[4] MarketResearch.com. (2022). Gastrointestinal Drugs Market Reports.
[5] WHO. (2021). Essential Medicines List updates.
