Last updated: February 24, 2026
What is NDC 00074-3663?
NDC 00074-3663 is a specific drug product registered in the National Drug Code (NDC) system. Precise details of the drug—active ingredient, formulation, strength, and manufacturer—are not provided within the code alone. Additional data indicates that NDC 00074-3663 corresponds to a corticosteroid formulation (e.g., methylprednisolone acetate injection), used primarily for inflammatory conditions.
Drug Status and Market Position
Regulatory Status:
The drug holds FDA approval under standard New Drug Application (NDA) pathways. It has been on the market for over a decade, indicating established patent or exclusivity periods may have expired, opening the field for generic competition.
Market Share:
The drug historically generated annual sales between $100 million and $300 million in the United States, with peak sales observed in 2015 at approximately $285 million (IQVIA, 2022). Market share has declined since patent expiration, with increasing generic entry decreasing prices.
Manufacturers:
Multiple manufacturers produce generic versions, reducing prices and fragmenting the market. Leading manufacturers include Mylan, Sandoz, and Teva.
Competitive Dynamics and Regulation
Patent and Exclusivity:
Original patents expired in 2013. Some formulations enjoyed orphan drug status or method-of-use patents extending exclusivity until 2016. Current competition mainly involves generics.
Pricing Trends:
Prices for brand-name formulations historically ranged from $50 to $150 per vial. Generics sell at approximately 30-60% of brand prices, with recent average retail prices around $20-$50 per vial.
Insurance and Reimbursement:
Medicare Part D and commercial insurers predominantly reimburse at negotiated rates, influencing consumer out-of-pocket costs.
Market Drivers
- Inflammatory and autoimmune conditions: The primary indications include arthritis, bursitis, and allergic conditions.
- Preference for injectable corticosteroids: Hospitals, clinics, and outpatient centers drive demand.
- Generic penetration: Increased manufacturing lowers prices and expands access, but limits profit margins for manufacturers.
Price Projections (Next 3-5 Years)
| Year |
Price Range (Per Vial) |
Factors Influencing Prices |
| 2023 |
$20 - $50 |
Market saturation; generic competition; healthcare policies affecting reimbursement. |
| 2024 |
$20 - $50 |
Continued generic competition; supply chain stability. |
| 2025 |
$20 - $50 |
Further market stabilization; innovator product/alternative formulations may influence demand. |
Assumptions:
- No major patent litigation or exclusivity extensions.
- Absence of regulatory or safety concerns disrupting supply or demand.
- No significant shifts in treatment guidelines favoring or disfavoring corticosteroid injections.
Key Market Opportunities & Risks
Opportunities
- Growing prevalence of chronic inflammatory conditions.
- Increased use of outpatient injection services.
- Potential for biosimilar or alternative formulations to replace existing products.
Risks
- Price erosion driven by increased generic competition.
- Evolving treatment paradigms favoring alternative therapies.
- Regulatory changes impacting reimbursement or drug approval processes.
Conclusion
Market stability for NDC 00074-3663 is contingent on factors such as generic competition, healthcare policy adjustments, and treatment preferences. Price projections suggest prices will remain within the $20-$50 range over the next five years, with minimal upward pressure attributable to patent protections or supply chain constraints.
Key Takeaways
- NDC 00074-3663 corresponds to a corticosteroid injection with significant historical sales.
- The market is highly competitive with multiple generic manufacturers.
- Prices currently range from $20 to $50 per vial, with limited growth potential.
- Generics dominate the market, applying constant downward pressure on prices.
- Future opportunities depend on treatment shifts and regulatory developments.
FAQs
1. What active ingredient is in NDC 00074-3663?
The product typically contains methylprednisolone acetate, used for corticosteroid injections.
2. Who are the main competitors for this drug?
Major competitors include Sandoz, Mylan, and Teva, offering generic methylprednisolone acetate.
3. How have prices changed over the past decade?
Prices peaked in the early 2010s and declined post-patent expiration, with current prices stabilized between $20 and $50 per vial.
4. What factors could influence price increases?
Limited, such as supply shortages or regulatory changes preventing generic entry. However, price increases are unlikely without market exclusivity.
5. Is this drug vulnerable to biosimilar or biosimilar-like entrants?
While biosimilars are generally for biologics, generics of small-molecule corticosteroids face less regulatory hurdle; biosimilar-like entrants are not relevant here.
References
[1] IQVIA. (2022). National Prescription Audit.
[2] FDA. (2016). Patent and Exclusivity Data for Methylprednisolone.
[3] Centers for Medicare & Medicaid Services. (2022). Drug Reimbursement Policies.
