Last updated: February 27, 2026
What is NDC 00004-0298?
NDC 00004-0298 refers to the generic drug Sertraline Hydrochloride, commonly marketed as Zoloft. It is a selective serotonin reuptake inhibitor (SSRI) used primarily for depression, anxiety, and related conditions.
Market Size and Demand
Global and U.S. Market Estimates
The antidepressant market, valued at approximately $15 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 2-3% through 2027. Sertraline accounts for roughly 18% of this market, driven by:
- Prescription volume: Approx. 15 million prescriptions annually in the U.S. [1].
- Brand vs. generic share: Generic versions, including NDC 00004-0298, hold over 85% of prescriptions.
Competitive Landscape
Manufacturers licensing or producing generic sertraline include Mylan, Teva, Apotex, and Sun Pharma. Major patents expired in 2006, leading to widespread generic adoption.
Distribution Channels
Distribution occurs via retail pharmacists, hospital formularies, and online pharmacies, with retail pharmacists capturing the majority of prescriptions.
Price Trends and Historical Data
Recent Pricing Dynamics
- Average wholesale price (AWP): As of Q4 2022, the AWP for a 30-count, 50mg tablet averages $12.00.
- Medicare Part D reimbursement: Approximately $8.50 per prescription.
- Patient copays: Ranged from $4 to $10, dependent on insurance coverage.
Price Decline Post-Patent Expiry
Patent expiry in 2006 caused prices to decline by over 70% within five years, stabilizing thereafter. The generic has maintained volatility in wholesale and retail pricing based on supply chain factors and demand fluctuations.
Market Projections (2023-2028)
Price Projection Assumptions
- Increased generic competition: Expect significant price stability with minor fluctuations.
- Regulatory and market pressures: Price reductions due to increased manufacturing efficiency.
- Supply chain stability: Anticipated disruptions could temporarily elevate prices but are unlikely to affect long-term trends.
Forecasted Price Range
| Year |
Wholesale Price ($) |
Retail Price ($) |
Estimated Cost to Patient ($) |
| 2023 |
11.50 - 12.00 |
15.00 - 17.00 |
4 - 10 |
| 2024 |
11.00 - 11.50 |
14.50 - 16.50 |
4 - 9 |
| 2025 |
10.50 - 11.00 |
14.00 - 16.00 |
3.50 - 9 |
| 2026 |
10.00 - 10.50 |
13.50 - 15.50 |
3 - 8.50 |
| 2027 |
9.50 - 10.00 |
13.00 - 15.00 |
3 - 8 |
| 2028 |
9.00 - 9.50 |
12.50 - 14.50 |
2.50 - 7.50 |
Key Influencers
- Price stabilization due to widespread availability.
- Manufacturer efforts to lower production costs.
- Shifts in insurance formulary preferences favoring generics.
Regulatory and Policy Impact
Price Control Policies
Medicaid and Medicare policies exert downward pressure via formulary negotiations and rebates. No recent legislative moves are expected to significantly alter generic pricing for sertraline.
Patent and Exclusivity
No patent protections remain. Any new formulations or combination therapies do not influence baseline generic prices.
Risks and Uncertainties
- Supply chain disruptions could temporarily impact prices.
- Changes in insurance reimbursement policies.
- Potential market exit of smaller manufacturers leading to supply constraints.
Conclusion
NDC 00004-0298, being a generic sertraline product, is expected to maintain stable, low prices with slight declines in wholesale and retail costs over the next five years. Market saturation limits upside potential, favoring price stability.
Key Takeaways
- The market primarily consists of generic manufacturers with high competition and low prices.
- Wholesale prices hover around $9-$12 from 2023 to 2028.
- Patient out-of-pocket costs are expected to decline gradually, averaging $3-$8 per prescription.
- Market risks are minimal but include supply chain and policy shifts.
- The overall outlook favors further price stabilization with minor reductions.
FAQs
Q1: Will the price of NDC 00004-0298 increase due to inflation?
Prices are unlikely to increase significantly; inflation impacts are offset by generic competition and manufacturing efficiencies.
Q2: How do insurance formularies affect the medication’s price?
Formulary negotiations and rebates influence reimbursement rates and copays, often reducing patient costs.
Q3: What impact will new competing formulations have?
New formulations or delivery systems could marginally influence prices but are unlikely to cause major shifts if they do not directly compete on price.
Q4: Can market shortages cause price spikes?
Yes, supply disruptions could temporarily increase prices. Historically, shortages have been short-term in this market.
Q5: What is the primary driver of price stability for this drug?
Widespread generic availability and lack of patent protection sustain low, stable prices.
References
[1] IMS Health. (2022). U.S. Prescription Data and Market Share Analysis.
