Last updated: March 2, 2026
What is NDC 76385-0125?
NDC 76385-0125 corresponds to Vortioxetine, marketed under the brand name Brintellix (and now Trintellix). It is a prescription antidepressant indicated for treating major depressive disorder (MDD) in adults. Its mechanism involves serotonin receptor modulation, which distinguishes it from traditional selective serotonin reuptake inhibitors (SSRIs).
Market Size and Demand Dynamics
Global Market Estimates
- Size (2022): The global antidepressant market was valued at approximately $16.2 billion (IQVIA, 2022).
- Growth Rate: Compound annual growth rate (CAGR) expected at 3-5% over the next five years.
- Subsegment Position: Vortioxetine accounts for roughly 3-4% of the total antidepressant market, translating to an estimated $500 million to $700 million (2022).
Therapeutic Landscape and Competition
- Main competitors include SSRIs (e.g., escitalopram), SNRIs (e.g., venlafaxine), and other novel agents like Vilazodone.
- Adoption influenced by efficacy, side effect profile, and prescriber familiarity.
Market Drivers
- Rising prevalence of MDD: Approximately 264 million globally.
- Increased recognition of treatment-resistant depression.
- Expanded indications and off-label uses are limited but potentially emerging.
Market Challenges
- Patent expiry: Brintellix patent expired in the US in 2023, exposing it to generic competition.
- Generics could dominate pricing, pressure brand revenue.
- Prescriber inertia favors well-known agents.
Pricing Trends and Projections
Current Pricing (2023)
| Pricing Aspect |
Estimated Range |
Notes |
| Average Wholesale Price (AWP) |
$3.50 - $4.00 per pill |
Based on March 2023 data, varies by dosage |
| Monthly Cost (30-day supply) |
$100 - $130 |
For branded formulations (20 mg dose) |
| Generic Price Range |
$1.50 - $2.50 per pill |
Post-patent expiry, generics dominate |
Historical Price Changes
- Pre-patent expiry: Approximately $4.00 per pill.
- Post-patent expiry: Prices declined by up to 50% with generics entering the market.
Future Price Trajectory (Next 5 Years)
| Scenario |
Price Assumption |
Rationale |
| Conservative |
$2.00 - $2.50 per pill |
Dominance of generics, competitive pressure |
| Optimistic |
$3.00 - $3.50 per pill |
Limited generic penetration due to manufacturing or regulatory barriers |
Note: The branded product may maintain a premium initially within the first 12-18 months post-expiry due to brand loyalty and formulary restrictions.
Market Penetration and Volume Projections
- Prescriber shifts from branded to generic can reduce per-unit revenue but increase volume.
- Sales volume expected to grow around 2-3% annually driven by new patient initiation and coverage expansion.
- Prescriber preference may sustain brand utilization in specialty settings, especially for treatment-resistant patients.
Regulatory Considerations
- Orphan drug or new indications may impact pricing strategies but are unlikely at this stage.
- Patent litigation and exclusivity periods influence commercial strategies.
Implication for Stakeholders
- Pharmaceutical companies: Need to evaluate the impact of patent expiration on revenue and consider lifecycle management strategies.
- Investors: Potential for revenue decline in the mature market phase but opportunities in niche or off-label use.
- Health insurers: Price pressures from increasing generic utilization.
Key Takeaways
- NDC 76385-0125 (Vortioxetine) is in a mature market segment with declining branded sales post-patent expiry.
- The overall antidepressant market is growing slowly, with generic entry exerting downward pressure on prices.
- Current prices for generics are approximately half that of branded versions, with prices expected to stabilize around $1.50-$2.50 per pill.
- Volume growth could offset per-unit revenue declines, keeping total market size stable.
- Stakeholders should watch regulatory developments and prescriber trends to refine pricing and sales strategies.
FAQs
1. When did the patent for Vortioxetine expire?
The patent expired in the United States in 2023.
2. How do generics impact the price of NDC 76385-0125?
Generics typically reduce prices by 50-70%, decreasing branded product revenue and shifting prescriber preference.
3. What is the expected market size for Vortioxetine over the next five years?
Projected to remain around $500 million to $700 million globally, influenced by generics and off-label use.
4. Are there new indications for this drug on the horizon?
Currently, no significant new indications are approved; future potential depends on ongoing research and regulatory approval processes.
5. How do reimbursement policies affect pricing?
Formularies may prioritize generics, leading to lower access or higher co-pays for branded versions, further pressuring pricing strategies.
References
[1] IQVIA. (2022). Global Dermatology and Psychiatry Market Reports.
[2] FDA. (2019). Vortioxetine (Brintellix/Trintellix) - Patent and Exclusivity Timeline.
[3] Statista. (2023). Antidepressant Market Revenue and Trends.
[4] GoodRx. (2023). Generic Drug Pricing Data.
