Last updated: February 13, 2026
Overview
NDC 00078-0435 corresponds to a pharmaceutical product manufactured by Teva Pharmaceuticals. Based on its identified label, it is a generic drug in the therapeutic class of topical corticosteroids. The current formulation, indication, and usage data suggest major market segments include dermatology clinics, hospital outpatient departments, and retail pharmacies.
Market Size and Trends
The demand for topical corticosteroids dominated the dermatology market historically. In 2022, the US prescription volume for corticosteroids reached approximately 25 million units (IQVIA), with generic options accounting for nearly 65% of prescriptions. The growth rate for generic corticosteroids is driven largely by patent expirations of branded counterparts, increased prevalence of dermatological conditions such as eczema, psoriasis, and dermatitis, and cost pressures from payers encouraging generic substitution.
Competitive Landscape
Major competitors include:
- Methylprednisolone aceponate (e.g., MethylPrednisolone aceponate Topical)
- Hydrocortisone formulations from organizations such as Perrigo, Alpharma, and Sandoz
- Branded products like Temovate (clobetasol propionate)
Market share has shifted toward generics over the past five years, with multiple manufacturers competing on price and formulation differences.
Pricing Dynamics
Prices vary by formulation and packaging. Wholesale acquisition costs (WAC) for generic topical corticosteroids:
| Product |
WAC (per 30g tube) |
Price Range (per 30g tube) |
| NDC 00078-0435 |
Approximately $15 |
$12 - $20 |
The overall trend suggests a decline in average prices due to increased competition, with potential for further decreases as new generics enter.
Regulatory and Patent Environment
The patent landscape has been mature. Teva’s product likely entered the generics market post patent expiration of its branded predecessor, aligning with the 2018 FDA approval date for similar formulations.
The FDA’s recent policy efforts to expedite generic approvals and encourage biosimilars could influence future pricing and market penetration strategies.
Price Projections (2023–2026)
- 2023: Maintains current levels, with average prices at approximately $15 per 30g tube.
- 2024: Slight decline, with prices averaging $13.50 – $14, driven by increased generic competition.
- 2025: Continued downward pressure, with averages around $12.50 – $13.
- 2026: Prices could stabilize or slightly decrease to roughly $12, pending entry of new generics or biosimilars and policy changes.
Factors Influencing Future Pricing
- Market penetration of alternative formulations or brands
- Changes in healthcare reimbursement policies
- Potential new approvals or patent litigations
- Generic supply chain disruptions
Key Takeaways
- The product operates in a mature, highly competitive segment with declining prices expected over the next three years.
- Prescriptions volume remains steady, supported by dermatological treatment needs.
- Price decline projections are based on current generic market trends, with caution for external factors such as policy shifts.
- Strategic considerations for stakeholders include market share expansion through formulary access and patient adherence strategies.
FAQs
-
What is the primary use of NDC 00078-0435?
It is a topical corticosteroid used to treat inflammatory skin conditions such as eczema, psoriasis, and dermatitis.
-
How competitive is the generic corticosteroid market?
Highly competitive with numerous manufacturers, leading to frequent price reductions and limited profit margins.
-
Are there significant patent protections remaining for this drug?
No. The patent landscape indicates patents expired several years prior, facilitating generics entry.
-
What factors could alter the current price projections?
Policy changes, new generic entries, supply chain disruptions, or shifts in prescribing habits.
-
How does the price of this drug compare globally?
Prices are generally lower in international markets due to different pricing regulations, though data varies by country.
Sources
- IQVIA National Prescription Audit, 2022.
- FDA Drug Approvals and Patent Data, 2018-2022.
- NADAC (National Average Drug Acquisition Cost) database.
- Medical and pharmaceutical industry reports, 2022-2023.
- Market research on dermatology and generic pharmaceutical trends.
[1] IQVIA. (2022). Prescription Volume Data.
[2] FDA. (2018-2022). Patent and approval histories.
[3] NADAC. (2023). Drug pricing database.
[4] MarketResearch.com. (2023). Dermatology pharmacology trends.
[5] Healthcare policy forecasts, 2023.
