Last updated: February 24, 2026
What is NDC 46122-0658?
NDC 46122-0658 refers to Rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor approved by the FDA for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer associated with BRCA mutation after response to platinum-based chemotherapy. It is marketed under the brand name Rubraca by Clovis Oncology.
Market Size and Demand Drivers
The Rucaparib market has demonstrated steady growth driven by its approval for multiple indications:
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Initial approval (December 2016): Treatment of advanced ovarian cancer with BRCA mutation.
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Expanded indications: Maintenance therapy post-chemotherapy (PRIMA trial approval, 2020), and treatment of prostate cancer (2019 in the US).
Estimated Market Volume and Prescriptions
- US prescriptions (2022): Approx. 8,500–10,000 annual prescriptions.
- Market penetration: Rucaparib holds approximately 15–20% share among PARP inhibitors; olaparib and niraparib are competitors.
Competitor Landscape
| Drug |
Market Share (2022) |
Indications |
Price (per 30-day supply) |
| Rucaparib |
15–20% |
Ovarian, prostate (expanded) |
$13,000–$15,000 |
| Olaparib |
40–45% |
Ovarian, breast, prostate, pancreatic |
$16,000–$17,000 |
| Niraparib |
35–40% |
Ovarian maintenance therapy |
$15,000–$16,000 |
Price Analysis
Current Pricing
- Average wholesale price (AWP): Approximately $13,500 for a 30-day supply.
- Discounted via payers/insurers: Actual prices paid are typically 20–30% lower.
Cost Factors Influencing Price Stability
- Manufacturing expenses: PARP inhibitors involve complex synthesis, affecting margins.
- Market exclusivity: Patent protections for Rucaparib extend into the late 2020s, delaying generic entry.
- Reimbursement policies: Medicare and private insurers negotiate discounts impacting net prices.
Price Projections (Next 5 Years)
| Year |
Estimated Average Price (per 30-day supply) |
Notes |
| 2023 |
$13,000 |
Stable, barring new competition |
| 2024 |
$12,500 |
Slight discounting to maintain market share |
| 2025 |
$12,000 |
Entry of biosimilars or generics unlikely yet |
| 2026 |
$11,500 |
Patent expiration approaches, pricing pressure increases |
| 2027 |
$10,500–$11,000 |
Potential generic entry, increased competition |
Regulatory and Patent Anticipations
- Patent expiry: Filed patents likely expire around 2028, opening markets for biosimilars and generics.
- Regulatory approvals: Expansion into additional cancer types or combination therapies could extend market viability.
Key Market Risks
- Generic competition: Entry of biosimilars or generics post-2028 may significantly lower prices.
- New competitors: Development of next-generation PARP inhibitors with improved efficacy or reduced costs.
- Reimbursement shifts: Changes in payer policies could influence net pricing.
Summary of Market Outlook
- The Rucaparib market remains stable with current pricing near $13,000 per month.
- Price declines are projected starting in 2026, coinciding with patent expiration.
- Market shares are expected to shift with competitor activity and potential new indications.
- The lack of immediate generic competition supports sustained prices until patent expiry.
Key Takeaways
- NDC 46122-0658 (Rucaparib) commands a high market price, supported by patent protections and limited competition.
- Market volume is driven by ovarian, prostate, and emerging indications.
- Prices are likely to decline gradually over the next five years, especially post-2026.
- Competition from biosimilars or generics, once patents expire, will be the primary price-reduction factor.
- Payer negotiation and reimbursement policies influence effective market prices.
FAQs
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What are the main indications for Rucaparib?
Ovarian cancer with BRCA mutations, maintenance therapy in ovarian cancer, and prostate cancer.
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How does Rucaparib compare with other PARP inhibitors?
It has similar indications but generally lower market share; pricing is comparable, with some variation.
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What patent protections support Rucaparib’s current pricing?
Patent protections extend into late 2020s; specific filings prevent immediate generic competition.
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When is generic entry expected?
Patent expiration anticipated around 2028, with biosimilars potentially entering within 1–2 years after.
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How might new indications or combination therapies affect the market?
Expanding indications could sustain or increase demand; new combinations might improve efficacy but could also introduce pricing pressures.
References
[1] FDA. (2016). FDA approves rucaparib for ovarian cancer. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-rucaparib-ovarian-cancer
[2] IQVIA. (2022). Prescription drug market data.
[3] Clovis Oncology. (2022). Rubraca product information.
[4] Statista. (2022). Market share of PARP inhibitors in oncology.
