Last updated: February 20, 2026
What is the drug identified by NDC 68462-0309?
NDC 68462-0309 corresponds to Rucaparib, marketed under the brand name Rubraca. It is a PARP inhibitor approved for treating ovarian, prostate, and other cancers.
Market landscape overview
Approved indications
- Ovarian cancer (maintenance and recurrent treatment)
- Prostate cancer (metastatic castration-resistant)
- Other solid tumors (investigational)
Regulatory status
- FDA approval granted in December 2016 for ovarian cancer.
- Expanded approvals in subsequent years include prostate cancer and other indications.
- Label updates and new indications are pending or under review.
Market size and growth drivers
| Indicator |
Value / Trend |
| Global oncology drug market size |
~$165 billion (2022), expected CAGR ~7% (2022-2027) |
| PARP inhibitor market share |
Estimated $8 billion in 2022, projected to reach $20 billion by 2028 |
| Rucaparib's market share |
Approximately 15% of PARP inhibitor sales (2022) |
| Key competitors |
Olaparib (Lynparza), Niraparib (Zejula) |
| Key growth drivers |
Increasing cancer prevalence, expanding indications, combination therapy approvals |
Key competitors and their positions
| Drug |
Market share (2022) |
Indications |
Pricing (2022, per 30-day supply) |
| Olaparib (Lynparza) |
~45% |
Ovarian, breast, prostate |
$12,000 - $15,000 |
| Niraparib (Zejula) |
~30% |
Ovarian, other solid tumors |
$11,500 - $13,000 |
| Rucaparib (Rubraca) |
~15% |
Ovarian, prostate |
$13,000 - $16,000 |
Price projections
Historical pricing trends
- 2020: Approximate retail price for Rucaparib was $14,000/month.
- 2022: Prices stabilized between $13,000 and $16,000/month, with slight regional variations.
- Price stability reflects regulatory constraints, manufacturer pricing strategies, and payer negotiations.
Future price expectations (2023-2028)
| Year |
Price Range (monthly) |
Factors influencing price |
| 2023 |
$13,000 - $16,000 |
Patent exclusivity, price negotiations, competitive positioning |
| 2024 |
$12,500 - $15,500 |
Potential biosimilar entry, market saturation, value-based pricing reforms |
| 2025 |
$12,000 - $15,000 |
Patent expirations, increased biosimilar competition, value pricing policies |
| 2026-28 |
$11,500 - $14,500 |
Biosimilar availability, US and international price harmonization |
Impact factors on pricing
- Patent protection: Expected to expire in the US around 2027, potentially leading to biosimilar entry.
- Reimbursement trends: Payer pressure, value-based contracts, and discounts may reduce net prices.
- Market penetration: As indications expand, volume growth may compensate for price declines.
- Regulatory changes: Cost-control policies in the US and abroad could impact pricing.
Pricing models
- List price: Assumes no discounts or rebates.
- Average selling price (ASP): Incorporates negotiated discounts, typical in payer contracts.
- Net price: Delivers to payers after rebates and discounts.
Estimated ASPs for 2023: $12,000 - $14,000/month, with the potential for decline as biosimilars enter.
Revenue projection for manufacturers
| Year |
Estimated global sales (USD billions) |
Key assumptions |
| 2023 |
$0.4 - $0.6 |
Continued clinician adoption, stable pricing |
| 2025 |
$0.8 - $1.2 |
Expanded indications, increased market penetration |
| 2028 |
$1.5 - $2.0 |
Biosimilar competition, geographic expansion |
Risks and uncertainties
- Patent expiration timelines.
- Competitive pressures from biosimilars.
- Regulatory shifts impacting pricing and reimbursement.
- Market acceptance of new indications or combination regimens.
Key takeaways
- Rucaparib (NDC 68462-0309) holds roughly 15% of the PARP inhibitor market, with stable pricing around $13,000-$16,000/month.
- Market growth is driven by expanding indications, aging populations, and combination therapies.
- Prices are expected to decline gradually over the next five years, especially if biosimilars emerge post-patent expiry.
- Revenue projections suggest potential growth from approximately $0.4 billion in 2023 to up to $2 billion by 2028, depending on competitive dynamics and approval expansions.
- Payer negotiations and regulatory changes will significantly influence net prices and market share.
FAQs
Q1: When is the patent for Rucaparib expected to expire?
A1: Patent protection in the US is expected to conclude around 2027, opening pathways for biosimilar competitors.
Q2: How does Rucaparib's price compare to its competitors?
A2: It is priced similarly to Olaparib and Niraparib, with a range of $12,000-$16,000/month, but with slightly higher typical list prices.
Q3: Will biosimilars significantly impact the Rucaparib market?
A3: Yes, biosimilar entry post-2027 could reduce prices and market share for Rucaparib.
Q4: What are the primary growth avenues for Rucaparib?
A4: Expanding indications, combination therapies, and geographic expansion are key growth drivers.
Q5: How do regulatory changes affect future pricing?
A5: Cost-control policies and value-based pricing reforms in key markets could place downward pressure on prices.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
[3] EvaluatePharma. (2022). PARP Inhibitors Market Forecast.
[4] SSR Health. (2022). Net Price Trends for Oncology Drugs.
[5] Statista. (2023). Cancer Incidence and Prevalence.
