Last updated: February 23, 2026
What is NDC 00069-3500?
NDC 00069-3500 refers to a specific formulation of the drug methylprednisolone sodium succinate. It is a corticosteroid used primarily for anti-inflammatory and immunosuppressive purposes in various clinical settings, including allergy, rheumatology, and acute adrenal insufficiency.
Product Overview
| Attribute |
Details |
| Manufacturer |
Pfizer (as of latest data) |
| Strength |
40 mg / 2 mL vials (lyophilized powder) |
| Formulation |
Injection, preservative-free |
| Approved Use |
Acute exacerbations of multiple sclerosis, inflammation suppression |
Market Size and Dynamics
Market Segments
- Hospital and Emergency Settings: The senior care, trauma, and emergency departments; dominant for injectable corticosteroids.
- Outpatient Clinics: For chronic inflammatory conditions, such as arthritis.
- Pharmaceutical Distribution: Supplies for compounding pharmacies and medical centers.
Key Market Drivers
- Rising incidence of autoimmune and inflammatory diseases.
- Expansion of outpatient treatment protocols.
- Increased use during COVID-19 for severe inflammatory responses.
- Greater awareness of corticosteroid therapies.
Market Size Data
| Year |
Global corticosteroid market (USD) |
CAGR (2018-2023) |
Market share of injectable corticosteroids (%) |
| 2018 |
3.2 billion |
4.8% |
25% |
| 2021 |
4.1 billion |
— |
— |
| 2023 |
4.4 billion |
— |
— |
Source: MarketsandMarkets [1]
The corticosteroid segment, specifically injectable methylprednisolone, holds approximately 20-25% of the total corticosteroid market.
Competitive Landscape
Major competitors include:
- Mylan (now part of Viatris)
- Sandoz (Novartis)
- Pfizer
- Teva Pharmaceuticals
Brands such as Solu-Medrol (Pfizer), Depo-Medrol (Pfizer), and generic equivalents dominate.
Price Projections
Current Pricing
- Average wholesale price (AWP) for a 40 mg vial ranges from $12 to $18.
- Contract prices for hospitals and distribution channels typically reduce this to $8–$14 per vial.
Price Trends and Drivers
- Generic Competition: Increased generic availability has driven prices downward by 15-25% over the past three years.
- Manufacturing Costs: Relatively stable, subject to inflation and raw material prices.
- Regulatory Factors: No recent patent protections; patent expiration occurred over a decade ago.
- Supply Chain Dynamics: Potential shortages or supply chain disruptions can temporarily alter prices.
Future Price Projections (Next 3-5 Years)
| Year |
Estimated Wholesale Price Range (per vial) |
Key Influences |
| 2024 |
$7–$13 |
Continued generic competition, inflation-adjusted costs |
| 2025 |
$6.50–$12 |
Potential supply chain constraints, increased demand in pandemic response |
| 2026 |
$6–$11 |
Market saturation, price stabilization |
Prices are expected to decline modestly, stabilizing near $6–$8 for bulk hospital purchasing.
Regulatory and Policy Impact
- No high barriers for production or distribution.
- FDA approvals remain in place without restrictions.
- No recent patent enforcement activity affecting pricing.
- Insurance reimbursement policies may influence actual payer prices.
Strategic Implications
- Entry into the methylprednisolone injectable market remains highly competitive.
- Price erosion due to generic proliferation makes high-margin opportunities limited.
- Focus on reliable supply chains and cost control can sustain margins.
- Expansion into emerging markets could provide growth avenues amid stagnant Western prices.
Key Takeaways
- NDC 00069-3500 is a methylprednisolone injectable used in acute inflammation cases.
- The global corticosteroid market is expanding, driven by rising autoimmune disease prevalence.
- Current wholesale prices for this formulation range $7–$13 per vial, trending downward.
- Competition, patent expiration, and generic availability exert downward pressure on prices.
- Future prices are projected to stabilize between $6 and $8 per vial, assuming supply chain stability.
FAQs
Q1: Is the drug NDC 00069-3500 still under patent protection?
No, it is a generic formulation with patent expiration long past, allowing multiple manufacturers in the market.
Q2: What are the main growth opportunities?
Market growth is driven by increased autoimmune disease prevalence and expanded outpatient use, especially in emerging markets.
Q3: How does supply chain disruption affect pricing?
Supply shortages can cause temporary price increases, but long-term trends favor price stability or slight declines due to competition.
Q4: What is the typical shelf life of this product?
The shelf life is generally 3 years from the manufacturing date when stored under appropriate conditions.
Q5: Are there regulatory risks impacting this drug?
No current regulatory risks foreseeably threaten its market status, barring unexpected safety or manufacturing issues.
References
[1] MarketsandMarkets. (2023). Corticosteroids Market by Type, Application, and Region.
