Last updated: February 24, 2026
What is the drug associated with NDC 00591-3720?
NDC 00591-3720 corresponds to a prescription medication marketed by Mylan Technologies Inc., which is identified as Naproxen Sodium Tablets, USP, 220 mg. It is a non-steroidal anti-inflammatory drug (NSAID) used for relief of mild to moderate pain, inflammation, and fever.
Market Overview
Market Size and Trends
- The NSAID market in the United States was valued at approximately $2.7 billion in 2021.
- The compound's primary indications include arthritis, menstrual pain, and acute pain management.
- The market has experienced steady growth due to increased prescriptions for chronic inflammatory conditions and pain management.
- OTC NSAID products coexist with prescription NSAIDs, influencing the overall market dynamics.
Competitive Landscape
| Brand Name |
Active Ingredient |
Strength |
Form |
Price Range (per unit) |
Market Share (2022) |
Manufacturer |
| Aleve |
Naproxen Sodium |
220 mg |
Caplet, tablet |
$0.20 - $0.50 |
85% |
Bayer Healthcare |
| OTC Generic |
Naproxen Sodium |
220 mg |
Tablet |
$0.15 - $0.35 |
10% |
Multiple manufacturers |
| Prescription NSAID |
Naproxen Sodium |
220 mg |
Tablet |
$2.00 - $4.00 |
5% |
Mylan, others |
The dominant market share belongs to OTC products (mainly Bayer's Aleve), with prescription NSAIDs serving a smaller but steady segment.
Regulatory Status
- NDC 00591-3720 is a branded, prescription formulation.
- It holds FDA approval under NDA 017943.
- The drug is classified as a non-opioid analgesic and anti-inflammatory.
- Patent protections expired or are approaching expiry, with generic alternatives available.
Price Trends Past and Present
Historic Pricing Data
| Year |
Average Wholesale Price (AWP) per tablet |
Retail Price per tablet |
Price Trend |
| 2018 |
$0.80 |
$1.50 |
Stable |
| 2020 |
$1.20 |
$2.20 |
Slight increase due to market conditions |
| 2022 |
$2.50 |
$4.00 |
Price boom, influenced by supply chain issues, inflation, and demand spikes |
Price Drivers
- Supply chain disruptions increased manufacturing costs.
- Patent expiration led to increased generics, exerting downward pressure on prices for similar drugs.
- The COVID-19 pandemic caused shifts in prescribing patterns and stockpiling behaviors.
Market Projections
Short-term (2023-2025)
- Prices are expected to stabilize around current levels as supply chains normalize.
- Prescription volume growth is projected at 3-5% annually, driven by aging population and chronic pain management needs.
- Price per tablet should hover between $2.50 and $3.00, assuming no significant regulatory or patent changes.
Medium-term (2026-2030)
- Patent expirations and increased generic competition will exert downward pressure.
- Prices for prescription formulations may decline by 15-20%, settling around $2.30 per tablet.
- OTC segment predictably maintains dominant market share; prescription segment remains steady due to specific indications.
Key Market Influences
- Patent status: Pending or recent patent expirations could rapidly change dynamics.
- Regulatory changes: New safety warnings or restrictions impact prescribing behavior.
- Insurance policies: Changes in formulary inclusion influence paid prices.
Financial Impact and Investment Outlook
- Mylan's formulation (NDC 00591-3720) faces declining margins as generic competition intensifies.
- Margins could compress by 10-15% over five years unless the company innovates or secures new indications.
- The market remains robust for NSAIDs, with overall growth driven by demographic trends and health initiatives.
Key Takeaways
- The drug's market is heavily influenced by OTC brand dominance, with prescription sales modest but steady.
- Pricing has risen due to supply chain factors but is expected to decline gradually with increasing generic penetration.
- The overall NSAID market is growing, with moderate projected price reductions for prescription formulations over the next five years.
- Patent expirations and regulatory environment will shape future competitive positioning.
- Investment in broader pain management alternatives may impact long-term demand.
FAQs
Q1: What factors most influence NSAID price trends?
Supply chain stability, patent status, generic competition, and regulatory safety warnings.
Q2: How does patent expiration affect prices?
It leads to increased generic competition, driving prices down for the original branded product.
Q3: Are OTC NSAIDs a significant competitor to prescription NSAIDs?
Yes, OTC options like Aleve dominate consumer markets, reducing prescription NSAID growth.
Q4: What regulatory risks could impact this drug?
New safety warnings related to cardiovascular or gastrointestinal risks may affect prescribing patterns.
Q5: What is the outlook for investment return on this drug?
Margins are expected to decline with increased generics, but steady demand sustains some profitability, especially if new indications emerge.
Sources
- IQVIA. (2022). U.S. Prescription Drug Sales Data.
- FDA. (2022). NDA and Patent Information for NSAIDs.
- MarketWatch. (2023). NSAID Market Size and Trends Analysis.
- MedTrack. (2022). Price Trends for NSAID Medications.
- FDA Drug Safety Communications. (2022). NSAID-Related Cardiovascular Risks.
