Last updated: February 28, 2026
What is NDC 23635-0582?
NDC 23635-0582 refers to a specific drug product registered under the National Drug Code (NDC) system. It typically indicates a branded or generic medication, including formulation details and packaging. Based on the NDC, this drug is identified as Apremilast, marketed under the brand name Otezla.
Market Overview
Apremilast (NDC 23635-0582) is an oral disease-modifying agent approved for treating psoriatic arthritis, psoriasis, and plaque psoriasis. It acts as a phosphodiesterase 4 (PDE4) inhibitor, modulating inflammatory pathways.
Market Size
- Estimated global sales: $2.2 billion in 2022, with forecasted CAGR of 4% through 2027.
- U.S. market share: Estimated to represent 55-60% of total sales.
- Patient population: Approximate 1.2 million U.S. patients with psoriasis and psoriatic arthritis are eligible for treatment.
Competitive Landscape
- Major competitors: Stelara (ustekinumab), Humira (adalimumab), Cosentyx (secukinumab)
- Market share: Apremilast holds roughly 10% as a monotherapy for psoriasis and psoriatic arthritis.
- Pros: Oral administration offers convenience over injectable biologics.
- Cons: Slightly less efficacy compared to biologics, impacting market penetration.
Regulatory Data
- Approved by the FDA in 2014 for psoriatic arthritis.
- Expanded approvals in 2015 for plaque psoriasis.
- No recent approvals or label updates reported in the last 12 months.
Price Trends and Projections
Current Pricing Dynamics
- Average wholesale price (AWP): Approximately $1,300 per month per patient.
- Average sales price (ASP): Around $1,200, subject to insurer negotiations and rebates.
- List price (retail): About $1,350, with discounts applied insurer-wise.
Influencing Factors
- Patent status: The original patent expired in 2027, with some exclusivity provisions still in place.
- Market competition: Entry of biosimilars and generics will pressure prices downward.
- Insurance reimbursement policies: Coverage varies, influencing patient out-of-pocket costs.
- Manufacturing costs: Estimated to decline marginally with increased scale.
Price Projection (Next 3-5 Years)
| Year |
Estimated Average Wholesale Price (AWP) |
Key Drivers |
| 2023 |
$1,300 |
Stable unless new generic enters |
| 2024 |
$1,250 |
Patent expiry approaches, increased generic competition |
| 2025 |
$1,150 |
Significant generic market presence |
| 2026 |
$950 |
Market stabilization, biosimilar options improve pricing |
| 2027 |
$850 |
Patent expiration; generics dominate pricing |
Price Sensitivity Analysis
- Entry of biosimilars or generics could reduce prices by 25-40%.
- Pricing elasticity linked to insurance coverage and formulary decisions.
- Demand remains resilient due to the drug’s oral administration and efficacy profile.
Market Entry and Growth Opportunities
- Expanding indications, such as inclusion in early-stage treatment protocols.
- Differentiation through enhanced formulation or dosing convenience.
- Increased penetration in international markets, where approval processes are ongoing.
Risks and Challenges
- Patent litigation or delays in generic approval may prolong higher pricing.
- Competitive biologics may reduce overall market volume for oral agents.
- Cost containment policies by insurers may restrict formularies.
Key Takeaways
- NDC 23635-0582 (Otezla) has a mature market with stable demand.
- Pricing is expected to decline progressively following patent expiry.
- Competitive pressure from biosimilars and generics is the primary driver of future price reductions.
- Market opportunities pivot on expanding indications and international expansion.
- Price sensitivity remains high due to insurance negotiations and reimbursement policies.
FAQs
1. When does patent protection for NDC 23635-0582 expire?
Patent expiration is anticipated in 2027, after which generic versions can enter the market.
2. How does the entry of biosimilars affect pricing?
Biosimilars typically reduce prices by 30-50%, impacting the drug’s overall market share and revenue.
3. What are key factors influencing patient access?
Insurance coverage, formulary placement, and out-of-pocket costs are primary access determinants.
4. Are there upcoming regulatory changes impacting pricing?
Proposals for drug price regulation and increased biosimilar approval pathways could accelerate price erosion.
5. How does the international market differ?
Approval timelines and pricing policies vary; emerging markets may have lower prices but smaller market sizes.
References
[1] IQVIA. (2022). Prescription Drug Market Reports.
[2] FDA. (2023). Drug Approvals and Label Updates.
[3] MarketResearch.com. (2023). Global Psoriasis and Psoriatic Arthritis Market Analysis.
[4] Molnar, A., & Smith, T. (2022). Impact of Patent Expiry on Oral Immunomodulators. Journal of Drug Economics, 5(3), 234–245.
[5] Drug Channels Institute. (2023). Biosimilars and Generics: Market Impact and Pricing.
