Last updated: February 13, 2026
What is NDC 51672-4063?
NDC 51672-4063 corresponds to Rucaparib (brand name: Rubraca), an oral PARP inhibitor used for treating ovarian cancer, prostate cancer, and other tumors. Approved by the FDA in December 2016, Rucaparib is marketed by Clovis Oncology.
Market Overview
Market Size & Growth
- The global ovarian cancer therapeutic market was valued at approximately $4.9 billion in 2022.
- The PARP inhibitor segment, which Rucaparib dominates alongside Olaparib and Niraparib, holds the largest share within this niche.
- Compound annual growth rate (CAGR) estimated at 12% from 2023-2028, driven by expanding indications and increased adoption.
Competitive Landscape
| Drug |
Brand Name |
Indications |
Market Share (2022) |
Regulatory Status |
| Rucaparib |
Rubraca |
Ovarian, prostate cancers |
~35% |
Approved in US, Europe, Japan |
| Olaparib |
Lynparza |
Ovarian, breast, prostate, pancreatic cancers |
~50% |
Approved in US, Europe, Japan |
| Niraparib |
Zejula |
Ovarian cancer |
~15% |
Approved in US, Europe |
Pricing & Reimbursement
- US list price for Rucaparib: approximately $14,560 per month (per patient).
- Insurance coverage predominantly through Medicare, Medicaid, and private payers; patient access depends on prior authorization.
The drug’s reimbursement landscape influences its market penetration, with high drug prices restricting affordability outside insurance.
Price Projections
Pricing Stability and Trends
- Current US list price: $14,560/month (~$175,000/year).
- List prices are stable, but net prices can be lower due to rebates, discounts, and negotiated purchase agreements.
- Price reductions may occur with increased biosimilar or generics options or through formularies favoring lower-cost alternatives.
Forecast (2023-2028)
| Year |
Estimated Price (USD/month) |
Notes |
| 2023 |
$14,560 |
Current list price in the US |
| 2024 |
$14,560 |
No significant change expected |
| 2025 |
$14,560 |
Slight decline possible based on negotiations and market dynamics |
| 2026 |
$14,560 |
Introduction of biosimilars or generics unlikely yet |
| 2027 |
$14,560 |
Price stability because of primary marketed indications |
| 2028 |
$14,560 |
Unless new competitors or biosimilars reach market, |
Influencing Factors
- Patent protection: Valid until at least 2029, limiting biosimilar entry.
- Regulatory approvals: Expanding indications (e.g., prostate) could increase demand.
- Market penetration: Higher adoption in clinical practice can sustain or grow revenues even with price constraints.
- Reimbursement policies: Tighter payor controls and discounts could materially affect net revenue.
Key Challenges & Opportunities
- Patent expiry looming (around 2029): Biosimilar competition could drive price erosion.
- Emerging indications: Label expansions could increase patient population and revenue.
- Market penetration: Broader adoption in Europe and Asia will influence long-term revenues.
- Pricing pressures: Payer demands and potential biosimilar development threaten the premium price point.
Conclusion
Rucaparib (NDC 51672-4063) maintains a high-cost, high-demand position within the ovarian cancer treatment segment. Short to medium-term pricing remains stable at approximately $14,560/month in the US, with slight downward pressure contingent on competitive dynamics and biosimilar entry post-2029.
Market expansion through new indications and geographic growth sustains overall revenue prospects. Price reductions are unlikely before patent expiry unless significant biosimilar competition develops.
Key Takeaways
- Rucaparib's US list price is roughly $175,000 annually, stable through 2028.
- Market growth driven by expanded indications and geographic reach.
- Patent protection until approximately 2029 limits biosimilar competition.
- Future price declines depend on biosimilar development, market competition, and payer negotiations.
- The market for ovarian cancer therapeutics remains lucrative, with PARP inhibitors leading the segment.
FAQs
1. When can biosimilars or generics be expected for Rucaparib?
Patent protection lasts until at least 2029, with biosimilar development likely aligned with this date, depending on regulatory and patent challenges.
2. Are off-label uses impacting Rucaparib’s market?
Yes, off-label uses in other cancers may expand demand, provided clinical evidence supports such expansion.
3. How do international prices compare?
European prices are generally lower, often 20-40% below US list prices due to different pricing and reimbursement systems.
4. What factors could accelerate pricing declines?
Introduction of biosimilars, increased competition, and policy changes targeting drug prices.
5. Is Rucaparib likely to see increased reimbursement in the future?
Reimbursement depends on regulatory approvals for new indications and health authority negotiations, which can improve access and revenue.
References
- IQVIA. "Global Oncology Market Size & Trends." 2022.
- FDA. "Rucaparib (Rubraca) Highlights of Prescribing Information." 2016.
- Clovis Oncology. "Rubraca (Rucaparib) Pricing & Reimbursement." 2023.
- EvaluatePharma. "Oncology Market Share & Future Outlook." 2023.
- CMS.gov. "Medicare Coverage and Payment of Cancer Drugs." 2023.
