Last updated: February 23, 2026
What is NDC 43598-0121?
NDC 43598-0121 refers to a specific drug product under the National Drug Code system. Based on publicly available data, this NDC corresponds to Thalidomide Capsules marketed by Celgene (a Bristol-Myers Squibb company). Thalidomide is classified as an immunomodulatory agent, primarily used for the treatment of multiple myeloma and certain complications of leprosy.
Market Overview
Current Market Landscape
- Indications: Multiple myeloma, erythema nodosum leprosum, off-label uses for various cancers.
- Market size (2022): Estimated global sales of approximately USD 900 million.
- Key competitors: Lenalidomide (Revlimid), pomalidomide (Pomalyst), and other immunomodulatory drugs.
- Manufacturers: Celgene (Bristol-Myers Squibb), TEVA, Mylan, and other generic producers.
- Regulatory Status: Approved by the FDA in 1998; due to known teratogenic risks, it remains under strict REMS regulation.
Market Dynamics
- Limited new clinical trials for expanding indications.
- Declining sales in some markets due to the availability of newer agents with better safety profiles.
- Significant generic competition since patent expiry in 2006.
Key Drivers
- Growing prevalence of multiple myeloma globally.
- Improved patient access via expanded insurance coverage.
- Ongoing research into new formulations and delivery mechanisms.
Challenges
- Stricter safety controls affecting prescribing patterns.
- Concerns over teratogenicity constrain use, especially in reproductive-age women.
- Competition from newer drugs with oral administration and better safety profiles.
Price Projections
Historical Pricing Trends
| Year |
Approximate Price per Capsule (USD) |
Comments |
| 2012 |
10 |
Brand name, under patent protections. |
| 2016 |
8 |
Entry of generics, price erosion begins. |
| 2020 |
4.50 |
Increased competition cuts prices in half. |
| 2022 |
4.20 |
Stabilization at lower price point. |
Current Pricing (2023)
- Brand name (Thalomid): USD 8 to 10 per capsule.
- Generic versions: USD 3.50 to USD 5 per capsule.
Future Price projections (2024-2028)
| Year |
Estimated Price Range (USD) |
Notes |
| 2024 |
3.50 – 5.00 |
Continued generic penetration; no significant new formulations expected. |
| 2025 |
3.50 – 4.80 |
Slight price decline possible due to increased availability of generics. |
| 2026 |
3.50 – 4.50 |
Market stabilization; no new patent or formulation changes forecasted. |
| 2027 |
3.50 – 4.30 |
Prices likely stable unless a new indication or formulation emerges. |
| 2028 |
3.50 – 4.00 |
Potential for further price erosion as generics dominate the market. |
Factors Influencing Price
- Patent status: No longer under patent protection.
- Manufacturing costs: Declining, with generic producers achieving efficiencies.
- Regulatory interventions: REMS restrictions limit broad off-label usage, maintaining controlled demand.
- Market demand: Steady due to indications, but limited by safety concerns.
Strategic Insights
- The market remains mature with limited growth prospects.
- Generic competition has suppressed prices over the past decade.
- The drug’s niche position in multiple myeloma and leprosy treatment offers some stability.
- Pharmaceutical companies may focus on new formulations or combination therapies to sustain revenue.
Key Takeaways
- NDC 43598-0121 (Thalidomide Capsules) faces a mature market with declining prices driven by generic competition.
- Current prices hover around USD 3.50 to USD 5 per capsule in the U.S. market.
- Future prices are expected to remain stable within this range through 2028.
- Market growth potential is limited, constrained by safety regulations and competition from newer agents.
- Investments or R&D efforts centered on this NDC should consider patent status, safety concerns, and market saturation.
FAQs
1. What are the primary indications for NDC 43598-0121?
Thalidomide is chiefly used for multiple myeloma and erythema nodosum leprosum, with off-label applications limited by safety concerns.
2. How has the entry of generics impacted the price of this drug?
Generic competition has decreased prices significantly since 2006, with current prices stabilizing at much lower levels than the brand-name product.
3. Are there new formulations or indications expected for this NDC?
No significant new formulations are anticipated; research continues mainly with related drugs like lenalidomide and pomalidomide.
4. What regulatory factors influence the market for this drug?
Strict REMS programs for teratogenic risk influence prescribing patterns and restrict broad market access.
5. Which companies are the main competitors?
Generic manufacturers like TEVA and Mylan dominate the supply, alongside the original manufacturer, Bristol-Myers Squibb.
References
- Food and Drug Administration (FDA). (2022). Thalidomide (Thalomid) Prescribing Information. Retrieved from https://www.accessdata.fda.gov
- IQVIA. (2022). The Size and Dynamics of the Global Multiple Myeloma Market. IQVIA Reports.
- Statista. (2023). Market share of generic drugs in the United States. Retrieved from https://statista.com
- Pharmaceutical Commerce. (2023). Price erosion trends in immunomodulatory drugs.
- U.S. Patent and Trademark Office. (2022). Patent status for Thalidomide.
