Last updated: February 22, 2026
What is NDC 83324-0034?
NDC 83324-0034 refers to a specific drug product, identified through the National Drug Code (NDC) system. Based on available databases, NDC 83324-0034 corresponds to Rucaparib (Rubraca) 300 mg oral tablets, indicated primarily for ovarian cancer treatment.
Market Landscape
Therapeutic Area
- Indications: Rucaparib is a PARP inhibitor used for maintenance therapy post-chemotherapy in homologous recombination deficiency (HRD)-positive ovarian cancer. It has expanded to include treatment of metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene mutations.
Market Size
- The global ovarian cancer drug market was valued at approximately USD 1.2 billion in 2022, with PARP inhibitors accounting for a significant share, driven by the approval of rucaparib, olaparib, and niraparib.
- The mCRPC PARP inhibitor segment is emerging, with revenue projections reaching USD 250 million by 2026.
Competitive Landscape
- Main competitors include:
- Olaparib (Lynparza): First-mover PARP inhibitor, with broader indications.
- Niraparib (Zejula): Offers maintenance therapy for ovarian cancer and falls under similar indications.
- Market share: Rucaparib holds approximately 30-40% of the PARP inhibitor market in ovarian cancer treatment, according to IQVIA data (2022).
Regulatory Status & Approvals
- FDA approval: December 2016 for ovarian cancer maintenance.
- Expanded labels: June 2020, including treatment in prostate cancer.
- European approval: Approved since 2018, with similar indications.
Price Analysis
Current Pricing
- List Price: The wholesale acquisition cost (WAC) for a 30-day supply (30 x 300 mg tablets) is approximately USD 12,000.
- Net Price: After discounts and rebates, payers typically pay USD 9,000 to USD 10,000 per month.
Comparative Pricing
| Drug |
Approved Indications |
List Price (USD/month) |
Market Penetration |
| Rucaparib |
Ovarian, prostate cancer |
12,000 |
30-40% of PARP inhibitor market |
| Olaparib |
Ovarian, breast, prostate |
13,000 |
Dominates market, ~50% share |
| Niraparib |
Ovarian maintenance therapy |
11,500 |
Growing share |
Future Price Trends
- Reimbursement pressures and biosimilar competition may lead to modest price declines over next 3-5 years.
- The entry of generic versions for Rucaparib is not imminent due to data exclusivity, but patent expiry could occur circa 2030.
- Contracting and formularies may lower actual net prices further, with some payers negotiating discounts up to 20-30%.
Price Projections (2023–2027)
| Year |
Estimated List Price (USD/month) |
Key Factors |
| 2023 |
12,000 |
Stable, pending policy and competition considerations |
| 2024 |
11,500 |
Potential slight discounting due to payer pressure |
| 2025 |
11,000 |
Increased market competition, biosimilar threat |
| 2026 |
10,500 |
Biosimilar approvals, patent expiry edging nearer |
| 2027 |
10,000 |
Price erosion, increased negotiations |
Key Market Drivers
- Expanding indications: Broader approved uses improve market volume.
- Pricing dynamics: Influenced by payer negotiations, value-based pricing, and reimbursement policies.
- Competitive pressures: Patent protection and biosimilars influence pricing.
- Regulatory changes: Reimbursement revisions or new approvals may adjust market size and pricing.
Key Challenges
- Patent expiration and biosimilar entry could substantially reduce prices.
- Market saturation in existing indications may slow revenue growth.
- Pricing pressure from payers prioritizing cost-effective therapies.
Regulatory and Supply Chain Insights
- No major supply constraints reported as of Q1 2023.
- Recent approval for prostate cancer indication enhances market potential but increases economic penetration complexity.
Conclusion
NDC 83324-0034 (Rucaparib) remains positioned as a mid-tier pricing PARP inhibitor with moderate market penetration in ovarian and prostate cancer indications. The current list price hovers around USD 12,000/month, with expectations of gradual declines driven by competition and patent expiration timelines. Major growth drivers include expanded indications and increased adoption.
Key Takeaways
- Rucaparib commands a list price of USD 12,000/month, with net prices around USD 9,500–10,000.
- The drug holds a 30-40% market share within PARP inhibitors for ovarian cancer.
- Price forecasts show a decline to USD 10,000/month by 2027 amid patent expiration and biosimilar entry.
- Broader indications and evolving reimbursement strategies can influence future market volume and pricing.
- Competition from olaparib remains a significant factor in market dynamics.
FAQs
1. How does Rucaparib’s price compare to other PARP inhibitors?
It is slightly lower than olaparib at USD 13,000/month, but comparable to niraparib, which is approximately USD 11,500/month.
2. What factors will most impact future Rucaparib prices?
Patent expiration, biosimilar development, regulatory changes, and payer negotiations.
3. Are biosimilars expected for Rucaparib soon?
Biosimilars are unlikely before 2030 due to data exclusivity periods, though patent challenges could accelerate this.
4. What is the primary driver for Rucaparib’s revenue growth?
Expansion into prostate cancer as well as approval for new indications in ovarian cancer.
5. How do reimbursement policies affect Rucaparib pricing?
Payers seek negotiated discounts and value-based agreements, often reducing prices below list levels.
References
[1] IQVIA. (2022). Global Oncology Market Data.
[2] U.S. Food and Drug Administration. (2016). FDA approval for Rucaparib.
[3] European Medicines Agency. (2018). Rucaparib marketing authorization.
[4] MarketWatch. (2023). PARP inhibitor market projections.
