Last updated: February 27, 2026
What Is the Drug Associated With NDC 65862-0467?
NDC 65862-0467 corresponds to Cymbalta (duloxetine) delayed-release capsules. Cymbalta is an antidepressant used for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain.
Market Size and Demand Dynamics
US Market Overview
- Market Penetration: Cymbalta held a leading position in the antidepressant segment since its FDA approval in 2004.
- Prescription Volume: As of 2022, approximately 4 million prescriptions were filled annually nationally.
- Pricing Tier: Historically, retail price per 30-capsule bottle ranged from $250 to $300, with variations based on pharmacy benefit plans and rebate agreements.
Key Market Drivers
- Brand Loyalty and Physician Preference: Cymbalta's established efficacy and safety profile sustain its prescribing rates.
- Generic Entry: Post patent-expiry in December 2018, generic versions entered the market, reducing costs and increasing accessibility.
- Reimbursement Trends: With increased insurance coverage, patient out-of-pocket costs declined in 2021-2022.
Competitive Landscape
| Product |
Manufacturer |
Formulation |
Year of Generic Entry |
Market Share (2022) |
Price Range (per capsule) |
| Cymbalta (brand) |
Eli Lilly |
30 mg, 60 mg |
2018 |
~20% |
$8-$10 |
| Generic Duloxetine |
Multiple |
Same as brand |
2018 |
~75% |
$1-$3 |
| Other Antidepressants |
Various |
SSRIs, SNRIs |
N/A |
Remaining share |
Varies |
Market Projections (2023-2027)
- Prescription Volume: Expected to decline modestly due to shifts toward newer antidepressants and generics' affordability.
- Annual Sales: Estimated to decrease from approximately $1.2 billion (2022) to ~$800 million by 2027.
- Market Share Shift: The brand's share will diminish further, mainly serving the remaining segment favoring the original formulation or physician preference.
Price Projection Analysis
Factors Influencing Future Pricing
- Patent Status: No patent protection since 2018; price is driven by generic competition.
- Market Entry of Biosimilars: Not applicable; duloxetine is a small molecule, not biologic.
- Distribution Channels: Mail order, retail pharmacy, and specialty pharmacies.
- Reimbursement Policies: Cost containment measures limit price increases; rebates and formulary placement significantly impact net prices.
Projected Price Range (Next 3-5 Years)
| Year |
Estimated Wholesale Price per Capsule |
Notes |
| 2023 |
$0.50 – $1.00 |
Competitive with existing generics |
| 2024 |
$0.45 – $0.95 |
Slight downward trend, price erosion ongoing |
| 2025 |
$0.40 – $0.90 |
Market stabilization, high generic penetration |
| 2026 |
$0.35 – $0.85 |
Continued price compression |
| 2027 |
$0.30 – $0.80 |
Bulk discounts and formulary shifts apply |
Key Price Drivers
- Generic manufacturers compete aggressively on price.
- PBMs and insurers prioritize cost-effective options.
- Manufacturing efficiencies push prices downward.
Summary of Risks and Opportunities
- Risks: Price erosion due to increased generic supply, declining demand, and shifts towards newer drugs.
- Opportunities: Brand maintenance through differentiation, new formulations, or indications. Potential for niche markets with stable demand.
Key Takeaways
- The drug NDC 65862-0467 is duloxetine capsules, primarily marketed as Cymbalta.
- Post-generic entry, market share has shifted heavily to generics, with the brand now capturing a small segment.
- Sales are projected to decline from over $1 billion in 2022 to approximately $800-900 million by 2027.
- Wholesale prices per capsule are expected to fall from roughly $0.50-$1.00 to $0.30-$0.80 over the next five years.
- Price dynamics remain heavily influenced by competition, reimbursement policies, and payer strategies.
FAQs
1. Will Cymbalta regain market share?
Limited. Market share may stabilize within niche segments but is unlikely to recover significantly against generics.
2. Are there new formulations or indications that could sustain prices?
Potentially, in special populations or new formulations under patent or exclusivity, but none currently exist.
3. How does generic competition impact pricing?
It exerts downward pressure, reducing both retail and wholesale prices.
4. What are the key factors influencing reimbursement?
Formulary decisions, rebate agreements, and negotiated discounts.
5. Will biosimilars affect duloxetine pricing?
No. Duloxetine is a small molecule; biosimilars are irrelevant. But new SNRI drug entrants could influence demand.
References
[1] U.S. Food and Drug Administration. (2022). Cymbalta (Duloxetine) Drugs@FDA.
[2] IQVIA. (2022). Prescription Data and Market Trends.
[3] GoodRx. (2023). Drug Price Comparison and Trends.
[4] National Center for Health Statistics. (2022). Prescription Drug Use Data.
[5] MedTech Insights. (2022). Generic Drug Price Erosion.
