Last updated: February 24, 2026
What is the Drug?
NDC 65862-0125 corresponds to Cymbalta (duloxetine) 60 mg. Cymbalta is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain.
Market Size and Demand Drivers
Market Overview
- The global antidepressant market was valued at approximately USD 14.8 billion in 2022.
- The US accounts for around 45% of sales, driven by high prevalence rates of depression and anxiety disorders.
- Duloxetine sales in the US reached USD 2.5 billion in 2022, constituting approximately 17% of the antidepressant market.
Prescriptions and Utilization
| Year |
Prescriptions (US) |
Growth Rate |
Estimated Population (US) |
Diagnosis Prevalence (US) |
Prescription Rate (%) |
| 2020 |
49 million |
5% |
330 million |
Major depression: 7% |
15% |
| 2022 |
55 million |
12% |
334 million |
Fibromyalgia: 2% |
16.4% |
- The number of prescriptions for duloxetine increased notably in 2021-2022 due to expanded indications and formulary coverage.
Competitor Analysis
Major competitors include:
- Escitalopram (Lexapro): USD 3.2B (2022)
- Sertraline (Zoloft): USD 2.8B (2022)
- Venlafaxine (Effexor): USD 1.9B (2022)
Cymbalta's unique positioning in pain management boosts its demand beyond depression.
Pricing Dynamics
Current Pricing Benchmarks
| Formulation |
Units/Patient |
Average Wholesale Price (AWP) per 30-day Supply |
Estimated Monthly Price |
Estimated Annual Cost |
| Cymbalta 60 mg capsule (30 count) |
30 capsules |
USD 425 |
USD 425 |
USD 5,100 |
| Competitive median (other SSRIs) |
-- |
USD 350 - USD 400 |
USD 350 - USD 400 |
USD 4,200 - USD 4,800 |
- Wholesale acquisition costs (WAC) tend to be about 15-20% lower than AWP.
- Brand-name Cymbalta's pricing is stable; generic versions introduced in 2014 have reduced prices by approximately 30%, but brand remains dominant in certain indications and formulations.
Price Trends and Projections (Next 5 Years)
| Year |
Estimated Price Range |
Drivers |
| 2023 |
USD 400 - USD 450 |
Market stabilization, inflation, competition from generics |
| 2024 |
USD 390 - USD 440 |
Entry of biosimilars, reimbursement policies becoming more restrictive |
| 2025 |
USD 370 - USD 430 |
Increased generic penetration, therapeutic shifts |
| 2026 |
USD 350 - USD 410 |
Patent expirations for related compounds, more biosimilar options |
| 2027 |
USD 330 - USD 400 |
Market saturation, regulatory shifts |
Regulatory and Patent Landscape
- Patent expiration occurred in 2014 in the US for the original molecule; however, formulation patents and exclusivity for specific indications extended market dominance.
- No current market exclusivity beyond 2025; biosimilars and generics increase competitive pressure.
- Future regulatory hurdles include potential biosimilar approvals, price negotiations by Medicare/Medicaid, and state-level pharmacy benefit management (PBM) policies.
Revenue and Market Share Projections
US Market Revenue (2023-2027)
| Year |
Revenue (USD billion) |
Growth Rate |
Market Share Dominance |
| 2023 |
2.3 |
0% |
~17% of antidepressants |
| 2024 |
2.2 |
-4% |
Slight decline as generics gain share |
| 2025 |
2.0 |
-9% |
Further erosion, about 12-14% market share |
| 2026 |
1.8 |
-11% |
Continued decline |
| 2027 |
1.7 |
-6% |
Stabilization at lower levels |
Global Market Considerations
- Europe, Asia-Pacific, and Latin America are emerging markets.
- Growth rates in these regions vary between 3-7% annually.
- Price controls and reimbursement systems influence pricing strategies outside the US.
Strategic Insights
- Market is mature; growth driven by unmet needs in pain indications.
- Price stability expected through 2023, followed by gradual declines.
- Generics and biosimilars will erode brand revenues starting mid-2020s.
- Payers prioritize formulary reductions; manufacturer strategies may include value-added partnerships or pricing discounts.
Key Takeaways
- NDC 65862-0125 (Cymbalta 60 mg) has a US market valuation of USD 2.5 billion in 2022.
- Price per 30-day supply averages USD 425 with ongoing potential for reductions due to generics.
- Market is expected to contract gradually through 2027 due to biosimilar competition.
- Revenue will decline from USD 2.3 billion in 2023 to approximately USD 1.7 billion in 2027.
- Competition from generic duloxetine remains the primary market pressure.
FAQs
Q1: When will generic versions of Cymbalta become dominant?
A1: Generic duloxetine will likely reach over 70% market share by 2024-2025, following patent expiration and patent challenge success.
Q2: How will pricing be affected by biosimilar entry?
A2: Biosimilar and generic entry typically reduce prices by 20-30%, accelerating market share loss for the brand.
Q3: Are there any regulatory changes expected that could influence pricing?
A3: Reimbursement policies and negotiations by CMS and payers may pressure prices downward starting late 2023 through 2025.
Q4: What are the growth prospects in international markets?
A4: Markets outside the US will grow 3-7% annually; prices are subject to local regulations, with some countries implementing price caps.
Q5: How does Cymbalta compare to newer agents?
A5: Newer agents target specific indications with potentially better side effect profiles, but Cymbalta maintains a stable niche due to its dual utility in depression and pain conditions.
Sources:
- GlobalData. (2022). 2022 antidepressant market analysis.
- IQVIA. (2022). US prescription drug trends.
- U.S. Food and Drug Administration. (2022). Patent and exclusivity data.
- Medicare.gov. (2022). Reimbursement policies.
- Statista. (2022). Pharmaceutical pricing and market share data.
