Last updated: February 17, 2026
Overview
NDC 00169-4524 is a drug marketed by Watson Laboratories, identified as "Benztropine Mesylate Injection." It is indicated for the treatment of extrapyramidal symptoms caused by antipsychotic drugs. The drug is primarily used in hospital and clinical settings for managing movement disorders associated with antipsychotic therapy.
Market Landscape
Product Profile and Regulatory Status
- Formulation: Injectable benztropine mesylate (0.5 mg/mL)
- Regulatory approval: Approved by the FDA, with standard expiration of exclusivity periods around 2030s based on original patent protections.
- Pricing history: Historically modest, reflecting its niche use and generic availability.
Market Size and Demand Drivers
- Target Patient Population: Patients on antipsychotics, particularly those with drug-induced movement disorders.
- Market Penetration: Low in outpatient settings; primarily used in hospitals.
- Global Reach: Limited primarily to the U.S. due to regulatory and market entry barriers.
Competitive Environment
- Immediate Competitors: Other injectable and oral agents for extrapyramidal symptom management, such as diphenhydramine, trihexyphenidyl, and benztropine orally.
- Brand vs. Generic: The drug is available as a generic, which limits premium pricing but ensures steady demand.
Price Projections and Revenue Estimates
Historical Price Data
| Year |
Average Wholesale Price (AWP) per 10 mL ampule |
Notes |
| 2018 |
$30 |
Typical for generic injectable formulations |
| 2020 |
$28 |
Slight decline amid increased generic availability |
| 2022 |
$27 |
Stable with minor fluctuations |
Current Pricing
- Average Wholesale Price (AWP): Approximately $27–30 per 10 mL ampule.
- Reimbursement and Net Price: Actual transaction prices to hospitals often lower, around 60–70% of AWP due to contracts and rebates.
Price Forecast (Next 5 Years)
| Year |
Predicted AWP Range |
Major Influences |
| 2023 |
$26–28 |
Stable market; generic saturation |
| 2024 |
$26–28 |
No significant patent challenges; steady demand |
| 2025 |
$25–27 |
Possible competition from biosimilars or new formulations |
| 2026 |
$24–26 |
Market saturation persists |
| 2027 |
$24–26 |
Reimbursement pressures intensify |
Factors Affecting Price and Market Dynamics
- Generic Competition: Increased entry from other suppliers depresses prices.
- Reimbursement Policies: CMS and private insurers' reimbursement policies influence net prices.
- Patent Expiry and Market Entry: The expiration of any remaining patents by the late 2020s opens additional generic manufacturers.
- Hospital Formularies: Adoption policies by hospitals affect demand stability.
- Technological and Formulation Developments: Introduction of new delivery forms or combination therapies could impact demand.
Revenue Potential
- Annual Market Value: With an average price of $27 and estimated usage of approximately 2 million units annually in the U.S., potential revenues are roughly $54 million.
- Key Markets: United States leads, with minimal international sales due to region-specific approvals and market access barriers.
Strategic Considerations for Investors and R&D
- Patent Litigation and Exclusivity: Monitoring patent statuses and litigation could impact market entry.
- Pricing Strategy: Lower-cost generics limit pricing power; focus on volume.
- Market Expansion: Opportunities exist in hospital formularies and specialty clinics, especially with expanding psychiatric and neurology care.
Key Takeaways
- The drug has a niche but steady role in managing antipsychotic-induced movement disorders.
- Pricing remains stable, influenced by generic saturation.
- Market growth potential is limited by existing generic competition and entrenched treatment options.
- Revenue projections suggest modest but predictable sales volumes with potential for growth in hospital settings.
- Regulatory and reimbursement policies will heavily influence pricing and market access over the next few years.
FAQs
1. What is the main use of NDC 00169-4524?
It is used for treating extrapyramidal symptoms caused by antipsychotic medications.
2. How competitive is the market for this drug?
The market is saturated with generics and alternative therapies, limiting pricing power but ensuring stable demand.
3. What are the primary factors influencing its price in the next five years?
Generic competition, reimbursement policies, and potential new formulations.
4. Is there potential for price increases?
Limited, as the market is mature; price stability is more likely unless new formulations or patents emerge.
5. How does international availability compare?
Limited availability outside the U.S., with minimal international sales due to regional regulatory differences.
Citations:
[1] Blue Book Data, Drug Pricing Trends, 2023.
[2] FDA Label and Patent Data, 2022.
[3] IQVIA, U.S. Pharmacy Market Data, 2022.
