Last updated: February 27, 2026
What Is NDC 64980-0449?
NDC 64980-0449 is a prescription drug listed within the National Drug Code directory. It corresponds to Rucaparib (brand name: Rubraca), a PARP (poly ADP-ribose polymerase) inhibitor approved by the FDA for multiple cancer indications. Specifically, it is indicated for treatment in:
- Ovarian cancer (including BRCA mutated)
- Prostate cancer
The drug was approved in the United States in December 2016 for ovarian cancer and expanded in 2020 for prostate cancer.
Market Size and Growth Drivers
Current Market Landscape
| Parameter |
Data (2022) |
Sources |
| Global ovarian cancer drug market |
Estimated $2.5 billion |
[1] |
| U.S. prostate cancer drug market |
Estimated $1.2 billion |
[2] |
| Rucaparib's estimated market share |
Approximately 12% of ovarian cancer PARP inhibitors in the U.S. |
[3] |
| Number of patients (ovarian, US) |
22,000 new cases annually (ovarian), 170,000 living with disease (US) |
[4] |
| Number of prostate cancer cases (US) |
268,000 total cases, with 34,000 new diagnoses annually |
[5] |
Growth Projections
The PARP inhibitor class is projected to expand at a compound annual growth rate (CAGR) of 10–12% over the next five years, driven by:
- Expanded indications (e.g., earlier lines of therapy)
- Increasing prevalence of BRCA mutations
- Advances in companion diagnostics
Competitive Landscape
| Drug |
Market Share (2022) |
Indications |
Price (USD per treatment cycle) |
Approval Year |
| Olaparib (Lynparza) |
~50% |
Ovarian, breast, prostate, pancreatic |
$13,500 |
2014 |
| Niraparib (Zejula) |
~30% |
Ovarian, breast |
$14,000 |
2017 |
| Rucaparib (Rubraca) |
~12% |
Ovarian, prostate |
$13,200 |
2016 |
Price Trends and Projections
Historical Pricing
Since its FDA approval, Rucaparib has maintained a wholesale acquisition cost (WAC) of approximately $13,200 per month per patient, translating to roughly $158,400 annually. Insurance coverage and negotiations often reduce actual patient out-of-pocket costs.
Future Price Drivers
- Market Competition: Entry of generics will pressure prices downward.
- Manufacturing Costs: Expected to decrease with scale, potentially leading to lower list prices.
- Market Penetration: As Rucaparib gains broader adoption and indications expand, economies of scale might stabilize prices.
- Regulatory Adjustments: Price negotiations through Medicaid, Medicare, and private insurers can influence final prices.
Price Projections (Next 5 Years)
| Year |
Projected Avg. Price per Cycle (USD) |
Assumptions |
| 2023 |
$13,200 |
Stable with current brand pricing |
| 2024 |
$11,880 |
Slight decline due to generic competition (~10%) |
| 2025 |
$10,560 |
Increased generic market share (~20%) |
| 2026 |
$9,240 |
Regional payer discounts (~30%) |
| 2027 |
$8,000 |
Market saturation; multiple generics available (~40-50%) |
Regulatory and Patent Considerations
- Patent Expiry: Patent protection expected to expire around 2028, leading to generic entry.
- Orphan Drug Designation: May provide market exclusivity until 2028 in certain indications.
- Pricing Regulations: Growing scrutiny on high-cost oncology drugs might influence future pricing policies.
Key Takeaways
- The Rucaparib market is mature, with stable pricing around $13,200/month, but faces impending generic competition.
- Market growth is primarily driven by expanding indications and increasing prevalence of BRCA mutations.
- Price projections indicate a potential decline of approximately 40-50% over five years, assuming typical generic market dynamics.
- Regulatory and patent status will heavily impact pricing strategies and market share.
FAQs
1. What is the primary indication for NDC 64980-0449?
Treatment of ovarian and prostate cancers, especially in patients with BRCA mutations.
2. When is generic competition expected to start?
Potentially around 2028, after patent expiration and loss of exclusivity.
3. How does Rucaparib compare in price to other PARP inhibitors?
Its list price is similar to Niraparib but slightly less than Olaparib, with prices ranging from $13,200 to $14,000 per month.
4. What factors could influence future pricing?
Introduction of generics, regulatory changes, insurer negotiations, market penetration, and indication expansion.
5. How large is the potential market for Rucaparib?
In the U.S., approximately 22,000 new ovarian cancer cases annually and 34,000 prostate cancer cases could be candidates for PARP inhibitors.
Sources
- MarketsandMarkets. (2022). Oncology drugs market size.
- IBISWorld. (2022). U.S. prostate cancer treatment industry analysis.
- EvaluatePharma. (2022). PARP inhibitors market share and sales data.
- American Cancer Society. (2022). Cancer facts & figures.
- SEER Cancer Statistics Review. (2022). U.S. cancer epidemiology data.
[1] MarketsandMarkets, 2022.
[2] IBISWorld, 2022.
[3] EvaluatePharma, 2022.
[4] American Cancer Society, 2022.
[5] SEER Program, 2022.
