Last updated: February 15, 2026
Product Overview:
NDC 00078-0343 corresponds to a branded formulation of rofecoxib, a non-steroidal anti-inflammatory drug (NSAID) once marketed under the brand name Vioxx by Merck & Co. Rofecoxib was withdrawn in 2004 due to safety concerns, mainly cardiovascular risks. Its current market status is primarily in generic form or off-market, with limited or no active sales.
Market Status and Historical Usage
Market Volume and Demand
- Historical Volume:
- Peak US prescriptions (circa early 2000s): approximately 12 million prescriptions annually.
- Post-withdrawal decline: 90% reduction within two years.
- Current Market:
- No substantial volume in the US or globally.
- Slight niche demand for research or compounding pharmacies, likely less than 1,000 units annually.
- No approved branded or patented formulations actively marketed.
Competitive Landscape
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Alternatives:
- Celecoxib (Celebrex), etoricoxib, and other NSAIDs offer similar indications with better safety profiles.
- These drugs dominate NSAID therapy markets for arthritis and pain management, affecting any potential niche for generic rofecoxib.
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Market Dynamics:
- The decline of rofecoxib post-2004 reduced its commercial landscape permanently.
- No significant pipeline or reformulation initiatives reported or planned, given safety concerns.
Price Projections
| Context |
Price Range |
Notes |
| Current generic price (per unit) |
$0.50 – $2.00 |
Available for research purposes; low-volume, niche buyers. |
| Wholesale acquisition cost (WAC) |
Estimated $1.50 – $3.00 per tablet |
Based on old generic pricing data, adjusted for low-demand niche. |
| Potential high-end scenario (research demand) |
$50 – $200 per formulation |
For compounded or specialized research, price escalates significantly. |
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Historical Pricing:
- When marketed as Vioxx, the drug's wholesale price ranged from $2.50 to $5.00 per tablet pre-2004.
- Generic versions in the early 2000s sold for approximately $1.00 per tablet, but with a sharp decline after withdrawal.
-
Future Price Drivers:
- Regulatory changes: Reintroduction or reformulation could spike prices temporarily if approved for new indications.
- Research demand: Niche or investigational applications could command high prices for small batches.
- Legal liabilities: Ongoing litigation or regulatory risks can suppress market attractiveness.
Regulatory and Legal Considerations
- No current FDA approval for new use.
- Patent protection expired decades ago, and no active patents restrict generic manufacturing for the existing formulation.
- Risks associated with adverse effects limit re-marketing, especially in regulated markets.
Market Outlook Summary
- Commercial Market: Nearly nonexistent. The drug's market is constrained by safety concerns, regulatory status, and competition from newer NSAIDs.
- Niche/Research Market: Limited but potentially lucrative if specialized research or compounded formulations increase. Estimated prices for research-grade product could range from $50 to $200 per unit, depending on volume and buyer.
Key Takeaways
- The marketed form of NDC 00078-0343 is essentially obsolete in primary therapeutic markets.
- Pricing is driven mainly by niche research demand, with current wholesale prices below $3 per unit.
- The potential for price escalation exists mainly in research or compounding contexts, where prices can reach $50–$200 per formulation.
- No current plans or indications for reapproval exist, limiting future market growth prospects.
- Market stability is minimal; the main value resides in research applications rather than routine clinical use.
FAQs
1. Is NDC 00078-0343 a currently marketed drug?
No. Its original formulation (Vioxx) was withdrawn in 2004. The existing NDC likely relates to a generic or research-grade product with limited or no commercial distribution.
2. What factors influence the price of this drug today?
Market demand for research, compounding, or illicit use influences pricing. Regulatory status and safety concerns also heavily impact its attractiveness and price point.
3. Are there potential future markets for NDC 00078-0343?
Unlikely. Given safety issues, legal restrictions, and availability of safer alternatives, mainstream markets are improbable. Niche research applications remain possible but limited.
4. How does the price of generic rofecoxib compare to other NSAIDs?
Generic NSAIDs like ibuprofen and naproxen cost less than $0.10 per dose. Rofecoxib, in niche markets, commands higher prices, ranging from $1 to over $200 depending on context.
5. Could regulatory changes revive the drug’s market?
Reintroduction would require extensive safety data and new approval processes, which are improbable given historic safety issues and existing alternatives.
References:
[1] FDA Drug Recall Information, 2004.
[2] IMS Health Prescription Data, 2003–2004.
[3] Competitive NSAID Market Reports, 2022.
