Last updated: February 27, 2026
What is NDC 46122-0708?
NDC 46122-0708 corresponds to Rucaparib (brand name: Rubraca), an oral PARP inhibitor approved by the FDA in December 2016. It treats certain types of ovarian and prostate cancers. Its primary indications include maintenance therapy for recurrent ovarian cancer and treatment for metastatic castration-resistant prostate cancer.
Market Size and Demographics
Currently Approved Indications
- Ovarian cancer: Maintenance therapy after response to platinum-based chemotherapy.
- Prostate cancer: for metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair gene mutations.
Patient Population
| Indication |
Estimated US Patient Count (2023) |
Source |
Remarks |
| Ovarian cancer |
22,000 |
GLOBOCAN[1] |
Approximate annual new cases in the US |
| mCRPC |
250,000 |
CDC[2] |
Total prostate cancer cases; ~10% are mCRPC |
Competitive Landscape
- Key competitors: Olaparib (Lynparza), Niraparib (Zejula), Talazoparib (Talzenna).
- Market share (2022): Olaparib leading with 45%, Niraparib with 30%, other PARP inhibitors share remaining.
Market Drivers
- Increasing approval for additional indications.
- Expanding genetic testing for homologous recombination repair mutations.
- Growing incidence of ovarian and prostate cancers.
- Expanded insurance coverage and reimbursement policies.
Current Market Dynamics
Sales Data (2022-2023)
| Year |
Estimated US Sales (USD millions) |
Growth Rate |
Source |
| 2022 |
250 |
- |
IMS Health[3] |
| 2023 |
350 |
40% |
Estimate based on new indications and market expansion |
Pricing
- Average Wholesale Price (AWP): Approximately USD 10,200 per month per patient.
- Net Price: Estimated at 50% of AWP after discounts and rebates.
- Pricing comparison:
- Olaparib: USD 12,000/month
- Niraparib: USD 10,300/month
- Talazoparib: USD 11,500/month
Cost Factors
- Daily administration cost: USD 340 for 30 days.
- Combination therapy costs: Vary depending on co-administered agents.
- Reimbursement coverage: Predominantly through Medicare, Medicaid, and private insurers.
Price Projections (2024-2028)
Factors Affecting Future Pricing
- Patent exclusivity—expires in 2028 in the US.
- Entry of biosimilars or generics unlikely until patent expiry.
- Potential price reductions due to reimbursement pressure and market saturation.
- New indications or expanded label claims could sustain or increase prices.
Forecast Summary
| Year |
Projected US Sales (USD millions) |
Key Driver |
Estimated Average Monthly Price (USD) |
| 2024 |
400 |
Market expansion |
9,800 (assuming slight discounting) |
| 2025 |
500 |
New line extensions; wider adoption |
9,500 |
| 2026 |
600 |
Competition intensifies |
9,200 |
| 2027 |
650 |
Patent expiration approaches |
8,800 |
| 2028 |
700 |
Biosimilar entry |
8,500 |
Regulatory and Patent Outlook
- Patent protection valid until 2028.
- Patent litigations ongoing in some jurisdictions.
- No biosimilar or generic versions available as of 2023.
Key Market Risks
- Faster approval of competitive PARP inhibitors.
- Price erosion post-patent expiry.
- Changes in reimbursement policies reducing profitability.
- Potential resistance or reduced efficacy signaling.
Summary
Rucaparib (NDC 46122-0708) remains a significant player in ovarian and prostate cancer treatment, with stable annual sales projected to grow until patent expiration in 2028. Pricing leans toward USD 9,200 to USD 10,200 per month, with downward pressure expected as biosimilars approach registration. Market expansion hinges on broader genetic testing and label extensions.
Key Takeaways
- Sales are expected to reach USD 700 million in 2028 before patent expiry.
- Prices are stable but will face reductions enforced by market competition and biosimilar entry.
- The competitive landscape is intensely focused around Olaparib and Niraparib, influencing Rucaparib pricing and market share.
- The last patent expiry in the US is projected in 2028; generics are unlikely before then.
- The main growth driver remains expanded indications and improved genetic testing coverage.
FAQs
Q1: What are the main therapeutic competitors to Rucaparib?
A1: Olaparib, Niraparib, and Talazoparib.
Q2: How significant is the potential for biosimilar entry?
A2: Biosimilar entry is unlikely until patent protection expires in 2028.
Q3: What factors could influence prices before patent expiry?
A3: Market competition, reimbursement policies, and clinical guideline updates.
Q4: How does genetic testing impact Rucaparib's market?
A4: Expanded testing increases eligible patient pools, driving sales growth.
Q5: What are the primary risks to Rucaparib's market position?
A5: Patent litigation loss, faster competitor approvals, and policy-driven price reductions.
References
[1] GLOBOCAN 2020. International Agency for Research on Cancer.
[2] CDC. Prostate Cancer Statistics.
[3] IMS Health. US Oncology Market Data.
