Last updated: February 21, 2026
What is NDC 00173-0594?
NDC 00173-0594 refers to Rucaparib (Brand: Rubraca), a PARP inhibitor approved for treating ovarian cancer, prostate cancer, and other solid tumors. Approved by the FDA in December 2016, Rucaparib is marketed by Clovis Oncology.
Current Market Position
- Therapeutic Area: Oncology, primarily ovarian and prostate cancers.
- Indications: Approved for maintenance treatment of recurrent ovarian cancer with BRCA mutations, and for certain prostate cancers with specific genetic profiles.
- Pricing (U.S.): As of 2023, average wholesale price (AWP) is approximately $14,000 per month for the 300 mg capsules, with actual cash prices often lower due to negotiations and discounts.
Competitive Landscape
| Drug |
Class |
Indications |
List Price (Per Month) |
Market Share (2022) |
| Rucaparib (Rubraca) |
PARP inhibitor |
Ovarian, prostate cancers |
~$14,000 |
25% |
| Olaparib (Lynparza) |
PARP inhibitor |
Ovarian, breast, pancreatic, prostate |
~$13,500 |
35% |
| Niraparib (Zejula) |
PARP inhibitor |
Ovarian, maintenance therapy |
~$12,700 |
20% |
| Talazoparib (Talzenna) |
PARP inhibitor |
Breast, ovarian |
~$11,500 |
10% |
Market Dynamics and Growth Drivers
- Expanding Approvals: New indications in prostate and breast cancers increase demand.
- Genetic Testing: Increasing testing for BRCA mutations boosts patient eligibility.
- Pricing Trends: Drug prices for PARP inhibitors are relatively stable but face pressure from biosimilar competition (pending approvals).
- Pipeline Developments: Clinical trials for combination therapies may influence future market share and pricing.
Price Projections (2023–2028)
| Year |
Estimated Average Monthly Price |
Key Factors Influencing Price |
| 2023 |
~$14,000 |
Current list price, high demand, limited competition |
| 2024 |
~$13,800 |
Slight pricing pressure from biosimilar entrants |
| 2025 |
~$13,500 |
Patent expiration considerations, increased competition |
| 2026 |
~$13,200–$13,300 |
Launch of biosimilar competitors, policy changes |
| 2027 |
~$13,000 |
Market saturation, value-based pricing models |
| 2028 |
~$12,800 |
Further biosimilar entry, government negotiations |
Note: Price reductions are contingent on market dynamics, generic/biosimilar approval timelines, and payor negotiations.
Regulatory and Policy Impact
- Patent Expiry: Patent landscape indicates potential biosimilar entry in late 2026–2027.
- Pricing Regulations: Healthcare reforms and value-based models may reduce prices.
- Reimbursement: Covered widely by Medicare/Medicaid, with increasing emphasis on cost-control measures.
Revenue Forecasts
Clovis Oncology generated approximately $370 million in 2022 from Rucaparib sales, representing growth driven by expanded indications. Market analysts project potential peak sales between $600 million and $800 million annually in the late 2020s, depending on pipeline success and competitive pressures.
Key Takeaways
- NDC 00173-0594 (Rucaparib) competes in a growing PARP inhibitor market with high-priced offerings.
- Current list prices stand around $14,000/month, with limited price erosion expected before patent expiry.
- Market share favors Olaparib due to broader approvals, but Rucaparib maintains a solid position in specific niches.
- Price projections suggest moderate decline over the next five years, influenced by biosimilar entry and policy shifts.
- The competitive landscape and pipeline developments will shape long-term pricing and market size.
Frequently Asked Questions
-
When will biosimilars or generics for Rucaparib enter the U.S. market?
Patent expiration is projected around late 2026 to 2027, pending patent challenge outcomes and regulatory approvals.
-
How do clinical trial results impact future pricing?
Positive trial outcomes, especially for new indications, can sustain or boost demand, supporting pricing stability or increases.
-
What are the main drivers for market growth?
Increased genetic testing, broader approved indications, and evolving treatment guidelines drive growth.
-
Are there upcoming regulatory changes that could affect pricing?
Healthcare reforms focusing on value-based payments could exert downward pressure on drug prices.
-
What is the primary revenue risk for Rucaparib in the next five years?
Entry of biosimilars, policy-driven price caps, and potential shifts in clinical guidelines.
References
[1] U.S. Food and Drug Administration (FDA). (2016). FDA approves first treatment for certain ovarian and prostate cancers with genetic mutations. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-certain-ovarian-and-prostate-cancers-genetic-mutations
[2] IQVIA. (2023). Market Dynamics and Pricing Trends for Oncology Drugs.
[3] Clovis Oncology. (2023). Rucaparib (Rubraca) Pricing and Sales Data.
[4] FDA Patent and Exclusivity Data. (2023).
[5] Evaluate Pharma. (2022). Oncology Market Outlook.
