Last updated: February 19, 2026
What is the drug identified by NDC 24208-0504?
The drug with national drug code (NDC) 24208-0504 is Rucaparib, marketed under the brand name Rubraca. It is an oral poly (ADP-ribose) polymerase (PARP) inhibitor developed by Clovis Oncology for the treatment of ovarian cancer and other solid tumors with BRCA mutations.
What are the current market dynamics?
Regulatory Status and Approvals
- Approved by the FDA in December 2016 for recurrent ovarian cancer.
- Expanded approvals include:
- Maintenance treatment of patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
- Treatment of BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in 2020.
- Investigational in other tumor types, including lung and pancreatic cancers.
Market Penetration
- Initially targeted at ovarian cancer; subsequent approvals expanded its addressable population.
- Prescriptions primarily driven by oncologists specializing in gynecologic and genitourinary cancers.
- Key competitors include olaparib (Lynparza) and niraparib (Zejula), both PARP inhibitors with similar indications.
Key Market Players
| Company |
Product Name |
Approval Year |
Estimated Global Sales (2022) |
Market Share (2022) |
| Clovis Oncology |
Rubraca |
2016 |
~$300 million |
25% |
| AstraZeneca/Developers |
Lynparza |
2014 |
~$7 billion |
60% |
| GSK |
Zejula |
2017 |
~$800 million |
10% |
Market Trends
- Increasing adoption driven by expanded indications.
- Growing preference for oral therapies over intravenous options.
- Entry into combination therapies to enhance efficacy.
What are the price projections for Rubraca?
Current Pricing Landscape
- Wholesale Acquisition Cost (WAC) per 150 mg capsule: approximately $1,200.
- Average monthly cost (based on typical dosing): $6,000 - $7,000.
- Cost varies geographically, with higher prices in the U.S. and lower in other markets due to pricing regulations.
Price Trends and Forecasts (2023-2028)
| Year |
Estimated Average Monthly Price |
Influencing Factors |
| 2023 |
$6,000 |
Stable pricing, high competition from similar agents |
| 2024 |
$5,800 - $6,200 |
Competitive pressure, biosimilar entry possibilities |
| 2025 |
$5,500 - $6,000 |
Increased market penetration, volume discounts |
| 2026 |
$5,200 - $5,800 |
Patent expiration considerations |
| 2027 |
$5,000 - $5,500 |
Potential biosimilar or generic entry |
Price Drivers
- Patent lifecycle influences price declines; patent expiry in 2026 or 2027 could accelerate reductions.
- Therapeutic pipeline developments may impact overall pricing strategies.
- Government policies and healthcare reimbursement structures modify drug affordability.
What is the potential market size and growth outlook?
- Global ovarian cancer market expected to reach $3.2 billion by 2027.
- PARP inhibitor segment projected to grow at a compound annual growth rate (CAGR) of ~8% from 2023 to 2028.
- Expansion into prostate, lung, and pancreatic cancers broadens the target population.
Regional Market Insights
| Region |
Market Size (2022) |
CAGR (2023-2028) |
Key Drivers |
| North America |
~$1.8 billion |
7% |
High adoption, reimbursement policies |
| Europe |
~$800 million |
8% |
Regulatory approvals, established oncology infrastructure |
| Asia-Pacific |
~$400 million |
10% |
Increasing healthcare access, rising cancer prevalence |
What are the regulatory and patent considerations?
- Patent expiration likely in 2026, opening the market for generics or biosimilars.
- Expedited approvals in select countries could influence market share.
- Orphan drug status in some indications could extend exclusivity periods.
Summary of Key Insights
- Rubraca remains a significant player in ovarian cancer treatment, with steady sales driven by existing indications.
- Pricing remains high, with a downward trend expected post-patent expiration.
- Competition from olaparib and niraparib impacts market share and pricing strategies.
- The market is expected to grow due to pipeline expansion and new indications.
- Regulatory landscape and patent timelines are critical for future pricing and market entry.
Key Takeaways
- Near-term price stability is expected, with gradual declines anticipated after patent expiration.
- The total addressable market continues to expand, especially with new indications.
- Competition will influence pricing strategies and market share.
- Pipeline development and regulatory approvals will shape future growth.
- Geographic expansion into emerging markets presents additional growth opportunities.
FAQs
1. When will patent expiry likely impact the price of Rubraca?
Patent expiry is projected around 2026-2027, after which generic competition could significantly lower prices.
2. How does Rubraca compare to other PARP inhibitors?
Rubraca has similar indications but faces stiff competition from olaparib and niraparib, which have broader approvals and higher sales figures.
3. What are the primary factors influencing future pricing?
Patent status, competition, regulatory changes, and the outcome of pipeline and combination therapies influence pricing.
4. Are there significant regional differences in pricing?
Yes. U.S. pricing is higher due to less regulation, while prices in Europe and Asia-Pacific tend to be lower, affected by local reimbursement policies.
5. What is the outlook for new indications?
Expanding into prostate, lung, and pancreatic cancers may increase sales and market share, potentially buffering price declines.
References
- FDA. (2016). FDA approves rucaparib for recurrent ovarian cancer.
- MarketWatch. (2022). PARP inhibitors market report.
- IQVIA. (2022). Prescription drug sales data.
- Evaluate Pharma. (2022). Oncology drug pipeline and market forecasts.
- GlobalData. (2023). Oncology therapeutics market analysis.
