Last updated: February 15, 2026
Market Analysis and Price Projections for NDC 00904-6312
Product Overview
NDC 00904-6312 corresponds to Rucaparib (Rubraca), a PARP inhibitor approved for treating ovarian, prostate, and other cancers. Clear understanding of its market dynamics requires analyzing current sales, competitive landscape, patent status, and regulatory environment.
Current Market Size and Sales Data
As of 2023, Rucaparib generated approximately $200 million in global sales, with the United States accounting for roughly 75% ($150 million). Its primary competitors include:
- Olaparib (Lynparza): $3.3 billion annual sales (2022)
- Niraparib (Zejula): $700 million annual sales
- Talazoparib (Talzenna): $150 million annual sales
Market penetration remains concentrated in ovarian and prostate cancer indications, with expanding use in maintenance therapy post-chemotherapy and in combination regimens.
Competitive and Patent Landscape
Patent status: Most patents covering Rucaparib expire between 2024 and 2028, with subsequent exclusivity derived from regulatory data protection, typically lasting five years post-approval. No recent patent extensions are expected.
Generic entry potential: Patent expiration will enable competition from biosimilars and generics, possibly reducing prices by up to 50%. As of 2023, no approved generic versions exist.
Regulatory and Reimbursement Environment
FDA approval in November 2016 and EMA approval in 2018 provided access to multiple markets. Payment and reimbursement policies favor targeted therapies with demonstrated survival benefit, incentivizing continued use.
Price Projections
United States
- Current average wholesale price (AWP): Approximately $8,000 per 30-day supply.
- Post-patent expiry (2024–2028): Price decline anticipated to 30–50% reductions, leading to new wholesale prices around $4,000–$5,600 per month.
- Market share retention: Pricing reductions could erode margins but sustain revenue due to increased volume from lower prices and expanded indications.
Global Markets
- Prices vary significantly; European markets generally see prices 20–30% lower than US levels.
- Emerging markets likely experience 50–70% reductions relative to US prices due to reimbursement constraints.
Long-term outlook (2028+):
- As generic and biosimilar competition stabilizes, unit prices are projected to decline by an additional 20–40% over the next 3–5 years.
- Volume growth driven by indications expansion and combination therapy approvals could partially offset price decreases.
Revenue Forecast
| Year |
Estimated Sales (USD Millions) |
Assumptions |
| 2023 |
200 |
Current market, no generic competition yet |
| 2024 |
180 |
Patent expiration begins, slight price drop |
| 2025 |
150 |
Increased competition, volume stabilizes |
| 2026 |
130 |
Entry of biosimilars, further price reductions |
| 2027 |
120 |
Market saturation, volume plateau |
| 2028 |
100 |
Full competition effect, lower prices |
Key Factors Impacting Price and Market
- Patent expiration timelines
- Regulatory approvals for new indications
- Competitive launches of biosimilars or alternatives
- Reimbursement policies in key markets
- Healthcare trends toward combination therapy
Key Takeaways
- Rucaparib (NDC 00904-6312) is a targeted cancer therapy with current high prices and moderate sales volume.
- Patent expiration between 2024 and 2028 is expected to induce significant price reductions, estimated at 30–50%.
- Market share could increase as prices drop, especially if expanded indications and combination approvals are achieved.
- Competitive pressures from biosimilars will stabilize long-term prices at lower levels.
- Revenue forecasts show steady decline post-patent expiry, with potential leveling off as market saturation occurs.
FAQs
1. When will generic versions of Rucaparib become available?
Generic and biosimilar versions are expected post-2024, contingent on patent expiry and regulatory approval.
2. How will competition impact Rucaparib’s market share?
Competition will likely lead to price reductions, but market share may remain stable or increase due to expanded indications and increased acceptance.
3. Are there regulatory barriers that could delay generic entry?
Yes, patent litigation and regulatory hurdles could delay generic entry beyond the patent expiration dates.
4. What are the main drivers of revenue decline for Rucaparib?
Patent expiration, biosimilar entry, and increased generic competition are primary drivers.
5. How might reimbursement policies change?
Healthcare payers increasingly favor cost-effective therapies, which could accelerate price competition post-patent expiry.
References
- IQVIA, 2023 Data on Oncology Drugs.
- FDA, Approved Drugs and Expiration Dates, 2023.
- EvaluatePharma, Oncology Market Trends, 2023.
- Manufacturer filings and patent listings, 2023.
