Last updated: February 24, 2026
What is NDC 45802-0138?
NDC 45802-0138 corresponds to Rucaparib, an oral PARP inhibitor approved by the FDA for maintenance treatment of recurrent ovarian cancer, specifically in cases with BRCA mutation-positive tumors.
Market Size and Demand
Indications and Usage
- Approved for maintenance therapy following platinum-based chemotherapy in recurrent ovarian cancers with BRCA mutations.
- Also approved for treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer with BRCA mutations after at least two chemotherapies.
Current Market Size
| Parameter |
Data |
| Target patient population |
Approximately 22,000 new ovarian cancer cases annually in the U.S. (per CDC) |
| BRCA mutation prevalence |
19% (hereditary BRCA mutations in ovarian cancer patients) |
| Eligible patients (estimated) |
~4,180 based on prevalence and treatment patterns |
Competitive Landscape
- FDA-approved PARP inhibitors: Olaparib, Niraparib, Talazoparib.
- Market penetration for Rucaparib is growing but limited by existing alternatives.
Market Dynamics
- Growing incidence of ovarian cancer globally.
- Expansion of approved indications could increase demand.
- Competitive pressure from established PARP inhibitors influences market share.
Commercial Introduction and Sales Trends
- Launched in the U.S. in 2018.
- Initial sales near $100 million in 2020.
- Growing at a compound annual growth rate (CAGR) of approximately 10-15%, influenced by:
- Expanded indications.
- Increased testing for BRCA mutations.
- Market penetration in Europe, Japan, and other regions.
Future Market Projections
| Year |
Estimated Sales (USD millions) |
Notes |
| 2023 |
$200 - $250 |
Market expansion and increased testing |
| 2025 |
$350 - $450 |
New indications and geographic expansion |
| 2030 |
$600 - $800 |
Broader application in maintenance therapy and other cancers |
Note: Projections based on current trends, market penetration, and regulatory approvals.
Pricing Analysis
Current Pricing
| Region |
Wholesale Acquisition Cost (WAC) per treatment course |
Notes |
| U.S. |
$11,000 - $12,500 |
Approximate; varies by payer and dose |
| Europe |
€8,500 - €10,000 |
Similar to U.S. adjusted for market |
| Japan |
¥1,200,000 |
Price reflects local healthcare policy |
Cost Components
- Per pill cost roughly $100 to $150.
- Typical course is six months of maintenance therapy.
- Price sensitivity exists due to competition.
Pricing Trends and Competitive Comparison
| Drug |
WAC per course |
Market share |
Regulatory status |
| Rucaparib |
~$11,500 |
10-15% |
Approved in multiple indications |
| Olaparib |
~$12,000 |
40-50% |
First in class, broader indications |
| Niraparib |
~$11,500 |
25-30% |
Widens indications in maintenance |
Price Projections
- Anticipated stabilization of current WAC unless competitor pricing impacts market.
- Potential discounts or rebates could lower effective prices.
- Future introduction of biosimilars or generics unlikely within the next 5 years due to patent protections.
Regulatory and Patent Landscape
- Patent expiry expected around 2030-2032.
- Biologics and small molecule exclusivities influence pricing strategies.
- Ongoing patent litigation or licensing agreements may impact market entry.
Conclusion
- Rucaparib's market is expanding primarily driven by increased testing for BRCA mutations and new indications.
- Estimated U.S. sales could reach $350–$450 million by 2025.
- Price per treatment course is expected to remain in the $11,000–$12,500 range unless market competition or regulatory changes occur.
Key Takeaways
- Rucaparib targets a niche but growing market within ovarian cancer treatment, with significant potential in maintenance therapy.
- Projected U.S. sales may reach nearly half a billion dollars by 2025, supported by demographic and clinical trends.
- Pricing remains stable but competitive dynamics and patents influence future pricing strategies.
FAQs
1. How does Rucaparib compare to other PARP inhibitors in efficacy?
It has demonstrated comparable efficacy to Olaparib and Niraparib in clinical trials, with differences mainly in side effect profiles and approved indications.
2. When does patent protection for Rucaparib expire?
Patents are expected to expire around 2030-2032, allowing for generic competition afterward.
3. Are there plans for expanding Rucaparib use beyond ovarian cancer?
Research is ongoing into its application in other BRCA-mutated cancers such as prostate and pancreatic, which could influence future sales.
4. What factors could impact Rucaparib pricing in the future?
Market competition, patent expirations, regulatory changes, and payer policies could affect prices.
5. How significant is the role of genetic testing in market growth for Rucaparib?
Testing for BRCA mutations is critical; increased adoption of genetic screening correlates with higher eligible patient counts and sales growth.
References
- Centers for Disease Control and Prevention. (2021). Ovarian Cancer Statistics.
- U.S. Food and Drug Administration. (2018). Rucaparib prescribing information.
- IQVIA. (2022). Oncology drug sales data.
- ClinicalTrials.gov. (2023). Ongoing trials involving Rucaparib.
- EvaluatePharma. (2022). Oncology market forecast.
[1] Centers for Disease Control and Prevention. (2021). Ovarian Cancer Statistics.
[2] U.S. Food and Drug Administration. (2018). Rucaparib prescribing information.
[3] IQVIA. (2022). Oncology drug sales data.
[4] ClinicalTrials.gov. (2023). Ongoing trials involving Rucaparib.
[5] EvaluatePharma. (2022). Oncology market forecast.
