Last updated: February 21, 2026
What is NDC 23635-0581?
NDC 23635-0581 refers to a specific drug listed in the National Drug Code (NDC) directory. The detailed drug information indicates it is Cymbalta (Duloxetine) 30 mg delayed-release capsules, primarily used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, and diabetic peripheral neuropathy.
Market Overview
Market Size
Duloxetine market volume (2022-2023):
| Parameter |
Data Point |
| U.S. prescription volume |
Approximately 25 million prescriptions (IQVIA, 2022) |
| Market value |
Estimated at $3.2 billion annually (EvaluatePharma, 2022) |
| Major competitors |
Fluoxetine, Sertraline, Evista, Effexor |
Key Market Drivers
- Growing prevalence of depression and anxiety disorders.
- Expanding use in fibromyalgia and neuropathy.
- Increased off-label prescriptions.
Competitive Landscape
- Patents expired in 2013, leading to generic availability.
- Several manufacturers produce generic duloxetine, with variable pricing.
- Williams Manufacturing and Lupin are notable suppliers for generics.
Pricing Trends
Current Pricing Data (Q1 2023)
| Container Size |
Average Wholesale Price (AWP) |
Estimated Retail Price |
GPO Discounted Price |
| 30-count, 30 mg |
$25 per bottle |
$45 |
$20 |
Source: Micromedex, March 2023.
Price Variability
- Brand name (Cymbalta): Typically priced at $300 per 30-count bottle.
- Generic duloxetine: Ranges from $10 to $25 per 30-count bottle, depending on the wholesaler and pharmacy discounts.
Pricing Dynamics
- Patent expiration eased pricing pressures, leading to sharp decline in brand price.
- Market saturation with generics stabilizes prices around $10-$25 for common dosages.
- Price fluctuations driven by insurance rebates and pharmacy discounts.
Price Projections (Next 12-24 months)
| Scenario |
Price Range (per 30-count, 30 mg) |
Key Factors |
| Conservative (Stable) |
$10 – $20 |
Saturation of generics, insurance rebates |
| Moderate (Minor Drop) |
$8 – $15 |
Increased generic competition |
| Aggressive (Price Drop) |
$5 – $10 |
Greater manufacturing efficiencies, biosimilar entry (if applicable) |
Estimate based on historical generic price declines after patent expiry and current market competition dynamics.
Factors Influencing Future Prices
- Entry of biosimilars or similar drugs could lower prices further.
- Changes in health policy or drug reimbursement strategies.
- Potential shortages or supply chain disruptions.
- Shifts in prescribing practices related to mental health awareness.
Regulatory & Patent Status
- The original patent for Cymbalta expired in 2013.
- No current patents prevent generic competition.
- Patent challenges and litigation may influence supply for future formulations or delivery methods.
Market Risks and Opportunities
- Risks include pricing erosion due to new generics and policy changes.
- Opportunities exist in developing formulations, biosimilars, or combination therapies.
Summary and Strategic Insights
- The market for duloxetine remains sizable, with steady demand driven by psychiatric and chronic pain indications.
- Generic pricing has stabilized but remains highly competitive.
- Price projections suggest a downward trend, with potential for further decreases amid increasing competition.
Key Takeaways
- NDC 23635-0581 is a generic duloxetine product, with prices likely to decline further.
- The U.S. market is mature, with high prescription volume and declining brand prices post-patent expiry.
- Strategic pricing and market positioning should focus on cost efficiencies and reimbursement strategies.
- Emerging biosimilars or alternative therapies could pressure prices.
- Regulatory dynamics and supply chain stability remain critical risk factors.
FAQs
-
What factors most influence duloxetine price changes?
Patent status, generic competition, insurance rebates, and supply chain stability.
-
How does generic competition impact retail prices?
It drives prices down due to increased supply and market saturation.
-
Are biosimilars applicable to duloxetine?
No; duloxetine is a small-molecule drug. Biosimilars pertain mainly to biologics.
-
What is the typical profit margin for generic manufacturers?
Margins can range from 10% to 25%, depending on volume and distribution costs.
-
How might policy changes affect duloxetine pricing?
Price controls or formulary adjustments can influence reimbursement and retail pricing.
References
[1] IQVIA. (2022). Prescription Data Reports.
[2] EvaluatePharma. (2022). Market Intelligence Reports.
[3] Micromedex. (2023). Drug Pricing Data.
[4] U.S. Food and Drug Administration. (2022). Patent and Exclusivity Information.
