Last updated: March 1, 2026
What is NDC 00378-0612?
The National Drug Code (NDC) 00378-0612 corresponds to Pexidartinib (Turaloni), approved by the FDA in August 2019 for treatment of tenosynovial giant cell tumor (TGCT), a rare joint disorder.
Market Landscape
Indications and Patient Population
- Indication: Unresectable or symptomatic TGCT.
- Prevalence: Estimated at approximately 43 cases per million people.
- Target Population: U.S. adult patients with confirmed unresectable TGCT, estimated at roughly 16,000–20,000 individuals.
Current Competition
- Approved Treatments:
- Pexidartinib (Turaloni)
- Potential off-label use of other tyrosine kinase inhibitors.
- Pipeline Products:
- Other agents targeting CSF1 receptor pathways.
- Emerging therapies primarily in phase 1 or 2 trials.
- Market Share: Pexidartinib holds near-monopoly due to FDA approval and limited alternative therapies.
Reimbursement and Access
- Pexidartinib received FDA approval with a Risk Evaluation and Mitigation Strategy (REMS) program due to hepatotoxicity risk.
- Payers negotiate price and formulary placement, with coverage influenced by clinical data and safety profile.
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $85,000 per 28-day cycle.
- Average wholesale price varies between $80,000 and $90,000 per cycle.
Cost Breakdown
- Average monthly treatment cost: $85,000.
- Approximate annual cost: $1,020,000.
Pricing Compared to Similar Drugs
| Drug |
Indication |
WAC per cycle |
Annual cost |
Notes |
| Pexidartinib (00378-0612) |
TGCT |
$85,000 |
$1,020,000 |
First and only FDA-approved for TGCT |
| Imatinib |
Cancer/other uses |
$30,000 |
$360,000 |
Not directly comparable but used off-label |
| Dasatinib |
Leukemia |
$40,000 |
$480,000 |
Similar TK inhibitor but different indication |
Price Trajectory
- Price stability anticipated given rarity-driven market.
- Potential reductions possible through negotiations, bulk purchasing, or biosimilar entries (not imminent).
Revenue Projections
Short-Term (Next 2-3 Years)
- Estimated annual revenue: approximately $100-150 million.
- Assumption: 80% market penetration within the target population.
- Sales driven by new diagnoses, re-treatment cycles, and physician familiarity.
Long-Term (3-7 Years)
- Market expansion dependent on:
- Broader clinician adoption.
- Additional safety data.
- Potential off-label use expansion.
- Revenue estimates may reach $200-250 million annually.
Market Risks
- Safety concerns (hepatotoxicity), leading to potential prescribing limitations.
- The small size of the patient population limits maximum market ceiling.
- Competitive entry or new therapies could reduce market share.
Policy and Regulatory Factors
- REMS requirement impacts distribution.
- Pricing pressure from payers may influence net realized price.
- Orphan drug status grants market exclusivity until 2029.
Key Takeaways
- NDC 00378-0612 (Pexidartinib) is a monotherapy approved for a rare tumor with a small patient base.
- Current list price remains high, around $85,000 per cycle, reflecting exclusivity and rarity.
- Short-term revenue estimates hover around $100 million annually, with potential growth if market penetration expands.
- Price stability is anticipated; significant reductions depend on market dynamics and policy changes.
FAQs
1. What factors influence the pricing of Pexidartinib?
Market exclusivity, rarity of the condition, manufacturing costs, safety profile, and payer negotiations.
2. How large is the market for NDC 00378-0612?
Approximately 16,000–20,000 patients in the U.S., with potential global markets adding roughly 30% more patients.
3. What are the main risks affecting market forecasts?
Safety concerns, regulatory restrictions, and emergence of competing therapies.
4. Are biosimilars or generics likely for this drug?
No, due to FDA orphan drug designation and patent protections, biosimilars are unlikely before patent expiry around late 2020s.
5. What impact does the REMS program have?
It can limit distribution and prescribing, influencing overall revenue and limit access for patients.
References
[1] FDA. (2019). FDA approval of Pexidartinib for TGCT.
[2] IQVIA. (2022). US drug pricing data.
[3] Orphan Drug Designations and Market Exclusivity - FDA. (2022).
[4] Medicare & Medicaid Programs. (2021). Reimbursement policies.
