Last updated: February 23, 2026
What is NDC 61958-2005?
NDC 61958-2005 corresponds to Rucaparib, an oral PARP inhibitor developed by Clovis Oncology. Approved by the FDA on December 19, 2016, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients with homologous recombination repair (HRR) gene mutations, Rucaparib is also approved for ovarian cancer following platinum-based chemotherapy.
Market Landscape
Indications and Patient Population
- Ovarian Cancer: Initially targeting advanced ovarian cancer with BRCA mutations.
- Prostate Cancer: Expanding into mCRPC with HRR mutations.
- Global prevalence estimates indicate:
- ovarian cancer: approximately 300,000 new cases annually (GLOBOCAN 2020).
- prostate Cancer: estimated 1.4 million new cases globally annually (WHO, 2020).
Competitive Environment
- Major competitors:
- Olaparib (Lynparza, AstraZeneca)
- Niraparib (Zejula, GSK)
- Talazoparib (Talzenna, Pfizer)
- Market share: Olaparib dominates for ovarian and prostate indications, capturing roughly 60-70% of PARP inhibitor revenues.
- Pricing landscape:
- Olaparib: $13,600 per month for ovarian cancer (price varies by payer and region).
- Niraparib: approximately $14,000 per month.
- Rucaparib’s price has historically been comparable, approximately $13,000-$15,000 per month, depending on indications and payer negotiations.
Sales and Revenue
- Historical sales (2021): ~$200 million for Rucaparib globally.
- Forecast growth:
- Compound annual growth rate (CAGR) estimated at 10-12% through 2027.
- Drivers: expansion into prostate cancer, earlier treatment lines, new combination regimens, and increased awareness.
Price Projections
Short-term (Next 2 Years)
- Given the current reimbursement environment and competition, Rucaparib will maintain pricing stability with minimal discounts.
- Estimated monthly price: $13,000-$14,000.
- Expected annual revenue: conservative estimate of $250-$300 million globally in 2024.
Mid-term (3-5 Years)
- Market expansion into earlier lines of therapy and additional indications could increase the patient pool by 50-70%.
- Potential for price adjustments downward of 5-10% driven by payer negotiations and biosimilar entry in other therapeutic areas.
- Estimated annual revenue: $400-$600 million by 2026.
Long-term (Beyond 5 Years)
- Introduction of biosimilars and generics in oncology drugs typically occurs 8-12 years post-approval.
- For PARP inhibitors, patent expiration is forecasted around 2026-2028.
- Price erosion factor: 20-30% reduction after patent expiry, with generic competition likely reducing prices further.
- Revenue projection: decline to $150-$250 million if biosimilar competition emerges.
Regulatory and Pricing Policies Impacting Price
- Reimbursement decisions differ by country:
- US: Medicare and private insurers negotiations limit maximum prices.
- Europe: Value-based pricing models influence drug pricing, with countries like Germany and the UK applying stricter controls.
- Cost-effectiveness assessments influence formulary positioning and payer reimbursement rates.
- The increasing use of outcome-based arrangements could pressure prices downward.
Key Drivers and Risks
| Driver |
Impact |
Risk |
| New indications |
Increased patient population |
Regulatory delays or rejections |
| Market expansion |
Revenue growth |
Competitive pricing pressure |
| Patent expiration |
Entry of generics |
Price erosion |
| Reimbursement policies |
Price stability |
Reimbursement restrictions |
Summary of Price Trends
| Year |
Approximate Monthly Price |
Notes |
| 2023 |
$13,000–$14,000 |
Stable, high competition |
| 2024 |
Slight decrease possible |
Negotiation-driven |
| 2026 |
Potential decline |
Patent expiry, biosimilar entry |
Conclusion
Rucaparib (NDC 61958-2005) is positioned as a differentiated PARP inhibitor within a highly competitive landscape. Pricing is expected to remain stable over the next two years, with moderate declines post-patent expiration. Market growth relies on expanded indications, combination therapies, and geographic penetration.
Key Takeaways
- Rucaparib's current price range is approximately $13,000–$14,000 per month.
- Sales are forecasted to grow in the 10-12% CAGR through 2027, supported by new indications.
- Price erosion is likely after patent expiration, with biosimilar competition anticipated around 2026-2028.
- Market expansion into prostate cancer and earlier therapy lines can increase revenues, offsetting price declines.
- Healthcare policies and reimbursement landscapes significantly influence pricing trajectories.
FAQs
1. What are the primary drivers of Rucaparib’s market share?
Expansion into prostate cancer, increased use in earlier treatment lines, and ongoing clinical trials are key drivers. Competition from Olaparib and Niraparib is significant but Rucaparib benefits from targeted approvals in specific indications.
2. How does Rucaparib’s price compare with its competitors?
Its monthly cost ranges from $13,000 to $15,000, similar to Olaparib and Niraparib, which operate within comparable price bands.
3. When is patent expiry expected for Rucaparib?
Patent protection is expected to end around 2026-2028, depending on jurisdiction and patent extensions.
4. What impact will biosimilars have on Rucaparib’s price?
Biosimilar competition typically causes price reductions of 20-30%, possibly reducing Rucaparib’s revenue significantly post-patent expiry.
5. Which geographic markets are most promising for Rucaparib?
The US remains the largest market, followed by Europe and Asia-Pacific, where approval processes are ongoing or under consideration.
References
[1] GLOBOCAN 2020. International Agency for Research on Cancer. International Agency for Research on Cancer (IARC).
[2] World Health Organization. (2020). Cancer country profiles.
[3] FDA. (2016). Rucaparib approval notice.
[4] IQVIA. (2022). Global oncology drug pricing estimates.
[5] EvaluatePharma. (2022). Oncology market forecasts and sales trends.
