Last updated: February 14, 2026
What is NDC 13107-0036?
NDC 13107-0036 refers to a specific formulation of vortioxetine, marketed as Brintellix (or Trintellix in some regions). It is prescribed for major depressive disorder (MDD). The drug's formulation details in this NDC include a 10 mg tablet intended for oral use.
Market Overview
Market Size and Dynamics
- Indication: Major depressive disorder affects approximately 17 million adults annually in the United States, according to the National Institute of Mental Health (NIMH).
- Treatment Penetration: Vortioxetine has gained market share among serotonergic agents, competing with selective serotonin reuptake inhibitors (SSRIs) like sertraline and escitalopram.
- Current Filings and Approvals: Approved by FDA in 2013. Later expanded to include additional doses and formulations.
Competitive Landscape
| Drug Name |
Market Share (2022) |
Key Competitors |
Approval Year |
Notes |
| Vortioxetine (Brintellix) |
~15% |
SSRIs (fluoxetine, sertraline) |
2013 |
Recent entry; gaining acceptance |
| SSRIs |
50-60% |
Fluvoxamine, citalopram |
1980s-1990s |
Dominant class in depression treatment |
| SNRIs |
20-25% |
Duloxetine, venlafaxine |
2004-2008 |
Alternative mechanism of action |
Market Drivers
- Growing awareness of depression treatment options
- Preference for drugs with fewer sexual side effects
- Expansion of dosing options for improved adherence
Market Challenges
- Competition from generic SSRIs and SNRIs
- Limited differentiation in efficacy
- Patent expiration risks causing price erosion
Price Projections
Current Pricing
- Typical retail price for a 30-day supply (30 tablets of 10 mg) ranges from $450 to $600, depending on pharmacy and insurance coverage.
- Wholesale Acquisition Cost (WAC) approximates $400 per month.
Historical Trends
- The drug's initial launch price ranged from $550 to $650 per month.
- Since 2018, prices have decreased (~5-10% annually) due to increased generic competition after patent expiration for other formulations (e.g., 5 mg and 15 mg doses).
Future Price Trends
| Year |
Estimated Wholesale Price |
Drivers |
Comments |
| 2023 |
$390 - $410 |
Increased generic competition, biosimilars |
Prices stabilize as generic options expand |
| 2024 |
$370 - $400 |
Biosimilar development, insurance negotiations |
Further price reduction as biosimilars enter the market |
| 2025 |
$350 - $380 |
Market saturation, formulary restrictions |
Potential stabilization or slight decrease |
Impact of Patent and Patent Challenges
- The key patents protecting vortioxetine’s specific formulations expire between 2024-2028.
- New patents or litigation could delay generics or biosimilar entry, maintaining higher prices temporarily.
Regulatory and Policy Factors
- Pricing and Reimbursement: Insurance coverage significantly impacts out-of-pocket costs; cost-sharing policies favor generics.
- Biosimilar/Generic Entry: Patent expirations are crucial to forecast price decreases.
- Government Negotiations: Medicare and Medicaid drug price negotiations might influence pricing strategies and market access.
Key Takeaways
- NDC 13107-0036 (vortioxetine 10 mg) commands a retail price of approximately $15 per tablet, translating into $450 monthly.
- The market is moderately consolidated with SSRIs and SNRIs dominating; vortioxetine's unique profile secures niche demand.
- Prices are declining gradually due to patent expirations and increased generic competition, with projections suggesting a decrease of 15-20% over the next two years.
- Patent expirations between 2024-2028 are likely to accelerate price depreciation and market share shifts.
FAQs
1. When do significant patent expirations for vortioxetine occur?
Major patent protections for vortioxetine are set to expire between 2024 and 2028, opening the market to generics.
2. What factors influence pricing beyond patent status?
Insurance reimbursement policies, formulary placements, manufacturer discounts, and competition greatly impact retail prices.
3. How does the competitive landscape affect future sales?
Generic entries and biosimilars will pressure prices downward, potentially reducing revenues for originator formulations.
4. Are there upcoming formulations or indications that could impact market dynamics?
New formulations or label expansions, such as for bipolar disorder or diabetic neuropathy, could create new revenue streams but are currently under investigation.
5. How do pricing strategies vary globally?
Pricing differs substantially; regions with price controls (e.g., Europe) generally see lower prices and slower declines compared to the US.
References
[1] National Institute of Mental Health. Major depressive disorder statistics.
[2] IQVIA. Drug Market Reports. 2022.
[3] FDA. Brintellix (vortioxetine) prescribing information. 2013.
[4] GoodRx. Vortioxetine pricing data. 2023.
[5] EvaluatePharma. 2023 World Market Forecasts.
