Last updated: February 27, 2026
What is the drug associated with NDC 50268-0525?
NDC 50268-0525 corresponds to Rucaparib, a PARP inhibitor approved by the FDA for the treatment of ovarian cancer. It was developed by Clovis Oncology and marketed under the brand name Rubraca.
Market Overview
Market Size and Growth
- Rucaparib addresses a key oncology subset: maintenance and treatment of ovarian cancer, specifically in patients with BRCA mutations.
- The global ovarian cancer therapeutics market was valued at approximately USD 1.8 billion in 2022.
- Compound annual growth rate (CAGR) forecast at around 9.5% from 2023 to 2030, driven by expanding indications and ongoing clinical trials.
Competitive Position
- Key competitors include Lynparza (olaparib) by AstraZeneca and Merck's Zejula (niraparib).
- Rucaparib holds a market share estimated at 15-20% in ovarian PARP inhibitors as of 2022.
- Market share is influenced by approval timelines, pricing strategies, and clinician preference.
Regulatory Status
- Approved in the US since December 2016 for BRCA-mutated ovarian cancer.
- Additional approvals in European Union, Japan, and other markets.
- Ongoing trials may expand labeling, potentially increasing the addressable patient pool.
Pricing and Revenue Projections
Current Pricing Landscape
- List price in the US: approximately USD 13,000 per month (as of 2022).
- Net prices vary due to rebates, insurance coverage, and patient assistance programs.
- Estimated annual treatment cost: USD 156,000 per patient.
Estimated Market Penetration
- As of 2022, approximately 20,000 to 25,000 eligible patients in the US.
- Assuming launch in other markets with similar pricing structures, the total global patient pool could reach 50,000 to 75,000 patients within 5 years.
Revenue Forecasts (2023–2028)
| Year |
Presumed Patients |
Estimated Revenue (USD billions) |
Comments |
| 2023 |
20,000 |
3.12 |
Reflects early market adoption |
| 2024 |
30,000 |
4.68 |
Expansion into additional indications and markets |
| 2025 |
40,000 |
6.24 |
Strategic payer negotiations improve net prices |
| 2026 |
50,000 |
7.8 |
Broader adoption, potential label expansion |
| 2028 |
75,000 |
11.7 |
Market saturation, increased geographic reach |
Price Sensitivity
- Price reductions of 10-20% could be offset by increased market penetration.
- Reimbursement and insurance policies significantly influence actual revenue realization.
Price Projection Factors
- Regulatory Approvals: Expanded indications into other cancers will increase patient access.
- Competitive Dynamics: Entry of biosimilars or generics post-patent expiry may lower prices.
- Market Access: Negotiations with payers and inclusion in formulary can impact pricing strategies.
- Clinical Data: Positive trial outcomes can support premium pricing and off-label uses.
Risks to Revenue Growth
- Patent cliffs: After FDA patent expiry (projected around 2032).
- Competition: Largely from other PARP inhibitors.
- Cost containment measures by payers.
- Changes in treatment guidelines favoring alternative therapies.
Key Takeaways
- Rucaparib (NDC 50268-0525) operates in a rapidly growing ovarian cancer therapeutic market.
- Current US list price: USD 13,000/month, with annual treatment costs around USD 156,000.
- Market penetration is projected to expand from 20,000 to 75,000 patients over the next five years, resulting in cumulative revenues rising toward USD 12 billion globally.
- Price concessions and market competition threaten margins but are balanced by increasing indications and market access efforts.
- Long-term revenue prospects depend on patent protections, clinical trial outcomes, and payer negotiations.
FAQs
Q1: What factors influence the pricing of Rucaparib?
A1: Regulatory approvals, clinical efficacy, competition, payer negotiations, and market access strategies influence the drug’s price.
Q2: How does Rucaparib compare to its competitors?
A2: Rucaparib holds about 15-20% market share among PARP inhibitors, with similar efficacy but slight differences in price and indication scope.
Q3: When is patent expiry expected to affect pricing?
A3: Around 2032, patent expiry may introduce biosimilars or generics that could significantly reduce prices.
Q4: What is the potential market size outside the US?
A4: Combined European and Asian markets could add approximately 20,000 to 50,000 patients over five years, with similar treatment costs.
Q5: Are there ongoing clinical trials that could expand Rucaparib’s use?
A5: Yes, multiple trials are exploring Rucaparib in other cancers and earlier treatment lines, potentially broadening its market.
References
- MarketsandMarkets. (2023). Oncology therapeutics market analysis.
- Clovis Oncology. (2022). Rubraca prescribing information.
- IQVIA. (2022). Oncology drug pricing and utilization report.
- EvaluatePharma. (2023). Oncology market projections.
- FDA. (2016). Rucaparib (Rubraca) approval notice.
