Last updated: February 16, 2026
What is the Drug NDC 00078-0457?
NDC 00078-0457 refers to a specific pharmaceutical product, identified by the National Drug Code (NDC). Based on available data, it corresponds to Benztropine Mesylate Injection. This drug is primarily used in the management of Parkinson's disease and drug-induced extrapyramidal symptoms.
Market Overview
Market Size and Usage:
Benztropine Injection has a niche but stable market. It is used in hospital settings and specialized clinics for acute management of extrapyramidal symptoms. Its annual sales in the U.S. are estimated around $25 million, based on data from IQVIA and other healthcare analytics sources.
Key End-Users:
- Neurologists
- Hospital pharmacy departments
- Movement disorder clinics
Geographical Reach:
Primarily used in the United States, with limited sales in Europe via import and compounded formulations. The therapeutic area’s regulation limits distribution to controlled environments.
Competitive Landscape
Major Players:
- Insight Pharmaceuticals (manufacturer of branded Benztropine Mesylate)
- Generic manufacturers, including Teva, Sun Pharma, Mylan, and Apotex
Market Share Dynamics:
Brand-name products account for roughly 60% of sales, with generics capturing the remaining 40%. The generic segment has increased in recent years, driven by patents expiration and formation of competition.
Alternative Treatments:
- Dantrolene for neuroleptic malignant syndrome
- Diphenhydramine for extrapyramidal symptoms
- Other anticholinergic agents like trihexyphenidyl
Regulatory and Supply Factors
FDA Status:
The drug is FDA-approved, with no recent recalls or major safety issues reported.
Supply Chain:
Manufacturing has experienced disruptions in 2020-2021, driven largely by raw material shortages. However, supply levels have stabilized as of 2023.
Price Trends and Projections
Current Pricing:
- Per vial: Approximately $70-$100 for a 2 mL vial (10 mg/mL concentration)
- Institutional bulk purchase pricing averages $65/vial.
Historical Pricing Trends:
Over the past five years, prices have increased roughly 3-4% annually, correlating with inflation, raw material costs, and regulatory compliance expenses.
Future Price Projections (Next 3-5 Years):
- Expected annual growth rate: 2-3%, lower than previous years due to market saturation and generic competition.
- By 2025, the average per-vial price is projected to be $80-$95.
- Potential for price stabilization or slight reductions driven by increased generic competition or new formulations.
Market Drivers and Risks
Drivers:
- Growing prevalence of Parkinson’s disease (estimated to affect over 1 million Americans)
- Increased use in hospitals for acute management of extrapyramidal symptoms
Risks:
- Entry of new generic competitors
- Changes in prescribing practices favoring oral formulations over injections
- Potential policy shifts impacting drug reimbursement or supply
Investment and R&D Potential
Incentives for Developers:
- Market remains limited but steady; pipelines for related neurodegenerative medications may indirectly boost demand.
- Investing in alternative formulations or combination therapies might open additional markets.
R&D Challenges:
- Limited patent exclusivity since the original patent expired decades ago
- Demand driven mainly by hospital protocols rather than retail markets
Key Takeaways
- NDC 00078-0457 (Benztropine Mesylate Injection) has a stable, niche market with annual sales around $25 million in the U.S.
- Price per vial is approximately $70-$100; anticipated growth rate of 2-3% annually through 2025.
- Competitive landscape favors generic manufacturers, meeting little pricing elasticity.
- Market growth is limited; future success depends on controlling supply chain costs and potential formulary shifts.
FAQs
1. Is there significant patent protection remaining for NDC 00078-0457?
No, the original patent has expired, leading to increased generic competition.
2. Are there upcoming regulatory changes that could impact this product’s market?
No major regulatory reforms are currently targeted at this drug. Future regulations could influence pricing or supply, but none are imminent.
3. What clinical alternatives could replace this drug in the future?
Oral anticholinergic agents like trihexyphenidyl may replace injectable forms in some settings. Newer therapies for Parkinson's management are also under development.
4. How might supply chain disruptions affect prices?
Persistent raw material shortages could constrain supply, potentially increasing prices temporarily but risking market shortage.
5. What opportunities exist for new formulations or delivery methods?
Injectable forms are standard, but research into oral or transdermal delivery could expand market share if proven safe and effective.
Citations:
[1] IQVIA. "Pharmaceutical Market Data." 2022.
[2] FDA. "Drug Approvals and Safety." 2023.
[3] National Parkinson Foundation. "Statistics and Treatment." 2022.
