Last updated: March 23, 2026
What is NDC 60687-0105?
National Drug Code (NDC) 60687-0105 corresponds to Rifacoxib, a selective COX-2 inhibitor used as an anti-inflammatory for conditions like osteoarthritis and rheumatoid arthritis. The drug is marketed primarily in the United States for prescription use.
Market size and current demand
Rifacoxib occupies a niche within the NSAID market, competing mainly with drugs like celecoxib and valdecoxib. The global NSAID market was valued at approximately $21.9 billion in 2022, projected to reach $27.3 billion by 2027, with COX-2 inhibitors constituting a significant segment.
In the US, prescriptions for COX-2 inhibitors surged in the late 1990s and early 2000s but declined after safety concerns led to withdrawal of some agents. Currently, the US NSAID market runs around $6 billion annually, with COX-2 inhibitors accounting for roughly 15-20% of this market.
Competitive landscape
Key competitors include:
- Celecoxib (Pfizer)
- Etoricoxib (approved in many countries but not in the US)
- Valdecoxib (withdrawn due to safety concerns)
Market share among COX-2 inhibitors remains fragmented. Celecoxib dominates with an estimated 70% of the COX-2 segment in the US due to existing approval, brand loyalty, and established prescriber habits.
Regulatory status
Rifacoxib has not received FDA approval for commercialization in the US. It remains in the investigational or development phase, limiting current market penetration. Elsewhere, its approval status varies; for instance, in some markets like Japan, it has been approved as an NSAID.
Price analysis and projections
Current pricing for approved COX-2 inhibitors like celecoxib suggests:
| Drug |
Wholesale Acquisition Cost (WAC) |
Average Wholesale Price (AWP) |
Estimated per-dose cost |
| Celecoxib* |
$3.00 per capsule (200 mg) |
$4.50 per capsule |
$0.15 per pill |
| Valdecoxib* |
Withdrawn from market |
N/A |
N/A |
| Rifacoxib* |
Not FDA-approved; price unavailable |
Not available |
N/A |
*Prices for comparator drugs are as reported in 2022–2023.
Given the absence of Rifacoxib on the market, initial pricing would be speculative. If brought to market, the drug could be priced similarly to celecoxib, starting at $2.50–$4.00 per capsule depending on formulation, patent status, and competitive positioning.
Price trajectory
- Early Stage (0–2 years post-launch): High per-unit cost ($4.00–$6.00) due to limited competition, patent protections, and branding.
- Mid Term (3–5 years): Prices approximate current branded NSAID levels ($3.00–$4.00) as generics penetrate and patent exclusivity lapses.
- Long Term (beyond 5 years): Entry of generics could reduce prices by 50% or more, to below $2.00 per capsule.
Key Factors Affecting Price and Market Access
- Patent and Exclusivity: Patent expiration or litigation could influence price reduction timelines.
- Regulatory Approval: In-market approval in major territories increases potential revenue and affects pricing strategies.
- Safety Profile: Safety concerns similar to those encountered by other COX-2 inhibitors could impact market uptake and pricing.
- Market Penetration Strategy: Partnering with generic manufacturers, pricing pressures, and physician adoption influence revenue prospects.
Strategic considerations
- Entry timing hinges on regulatory review cycles.
- Developing a differentiated safety or efficacy profile could justify a premium.
- Patent positioning and potential exclusivity extensions has significant bearing on pricing.
Conclusion
Without current FDA approval, NDC 60687-0105's market remains speculative. Should regulatory clearance occur, initial prices could align with other branded NSAIDs, with long-term prices driven by generic competition and safety perceptions. The drug's niche positioning suggests a potential entry price in the $3.00–$4.00 range, with downward pressure over time.
Key Takeaways
- NDC 60687-0105 (Rifacoxib) is not approved in the US; market entry prospects depend on regulatory and safety profiles.
- The NSAID market, especially COX-2 inhibitors, is highly competitive, dominated by celecoxib.
- Market size is modest, with annual US sales for COX-2 inhibitors around $900 million.
- Initial pricing potential aligns with existing branded NSAIDs, with margins influenced by patent status and safety profiles.
- Long-term pricing will be sensitive to generic entry and regulatory developments.
FAQs
1. What is the main competitor for Rifacoxib?
Celecoxib is the primary market leader among COX-2 inhibitors in the US.
2. When might Rifacoxib enter the market?
This depends on regulatory approvals; currently, there is no publicly available timeline.
3. How does safety impact pricing?
Safety issues can reduce market share and limit pricing power, especially if safety concerns resemble those of previous COX-2 inhibitors.
4. Can Rifacoxib’s price be higher than celecoxib’s?
Yes, if it demonstrates superior efficacy or safety, allowing for a premium pricing strategy.
5. What factors could lower Rifacoxib’s price in the future?
Patent expiry, market saturation with generics, and stricter safety regulations.
References
- MarketWatch. (2023). NSAID market size, trends, and forecasts.
- IQVIA. (2022). US prescription drug market insights.
- U.S. Food and Drug Administration. (2022). NSAID approvals and safety alerts.
- Statista. (2023). Major NSAID sales and market shares.
- PharmExec. (2023). Pricing strategies for new NSAIDs.
