Last updated: February 26, 2026
What is the Drug with NDC 64980-0349?
NDC 64980-0349 corresponds to Rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent ovarian cancer. Specifically, it is marketed under the brand name Rubraca by Clovis Oncology.
Market Size and Growth Dynamics
Current Market Landscape
- Indications: Rucaparib is approved for ovarian cancer, including maintenance and treatment in BRCA-mutated cases.
- Patient Population: The U.S. alone has approximately 20,000 new ovarian cancer cases annually, with about 50% testing positive for BRCA mutations.[1]
- Market Penetration: As of 2022, Rucaparib holds roughly 10% of the ovarian cancer drug treatment market by revenue, behind competitors like Olaparib (Lynparza) and Niraparib (Zejula).[2]
Competitive Environment
- Main Competitors:
- Olaparib (AstraZeneca)
- Niraparib (GlaxoSmithKline)
- Talazoparib (Pfizer)
- Shared Market: PARP inhibitors collectively generate approximately $4.5 billion globally in 2022, with Rucaparib accounting for about $600 million (13%) of this segment.[3]
Market Growth Trends
- Forecast Revenue Growth: Compound annual growth rate (CAGR) of 12% projected for the PARP inhibitor segment through 2027.[3]
- Driver Factors:
- Expanded indications (e.g., earlier lines of therapy)
- Increased testing for BRCA mutations
- Rising incidence of ovarian cancer
Pricing Landscape
Current Pricing Benchmarks
| Drug |
List Price (per treatment cycle) |
Approximate Annual Cost |
Market Share (2022) |
| Rucaparib (Rubraca) |
$12,000 |
$144,000 |
13% |
| Olaparib (Lynparza) |
$13,500 |
$162,000 |
35% |
| Niraparib (Zejula) |
$11,500 |
$138,000 |
32% |
Note: Prices are based on average wholesale price (AWP) estimates and may vary by provider and region.
Price Trends
- Price Stability: Rucaparib's price has remained relatively stable since launch in 2017, with minor adjustments due to pharmacy negotiations and insurance coverage.
- Potential for Price Reduction: Governments and insurers may negotiate discounts as market penetration increases and generic biosimilars or alternatives emerge.
Price Projections and Revenue Outlook
Short-term (2023–2025)
- Expect retention of current pricing levels given existing patent exclusivity.
- Revenue growth driven primarily by increased patient access and expanded indications.
Medium to Long-term (2026–2030)
- Entry of biosimilars or generic versions anticipated once patents expire (expected around 2033 based on patent extensions and data exclusivity).
- Price reductions estimated at 20–30% post-generic entry, potentially reducing annual treatment costs to approximately $8,500–$9,500.
- Revenue could decline proportionally unless new indications or combination therapies expand the market.
Key Factors Impacting Prices
- Patent expiry and generic competition.
- Reimbursement policies and insurance coverage.
- Regulatory approvals for new indications.
Regulatory and Patent Considerations
- Patent Status: Patent protection for Rucaparib extends to 2033, providing exclusivity for the next decade.[4]
- Orphan Drug Designation: Not applicable, which limits market exclusivity extensions.
- Potential Patent Challenges: The drug faces patent cliff risk; patent challenges or litigation could impact pricing.
Strategic Outlook
- Development of combination regimens (e.g., with immune checkpoint inhibitors) could sustain higher pricing due to combination therapy premiums.
- Geographic expansion, especially into emerging markets, offers growth avenues with lower price sensitivities.
Key Takeaways
- Rucaparib holds a niche but growing position in ovarian cancer treatment, with a global market size close to $600 million as of 2022.
- The overall PARP inhibitor segment is expanding at double-digit CAGR, supporting revenue growth.
- Pricing remains stable in the short term but is subject to decline post-patent expiry, with a forecasted 20–30% reduction after 2027.
- Patent protections extend into the early 2030s; patent challenges could alter this timeline.
FAQs
Q1: How does Rucaparib compare to other PARP inhibitors in terms of pricing and efficacy?
It is priced similarly to other PARP inhibitors, with minor variations. Efficacy data show comparable outcomes in ovarian cancer, though specific indications and patient populations may favor one over others.
Q2: When do patents for Rucaparib expire?
Patent protection is expected until 2033 unless extended claims or legal challenges alter the timeline.
Q3: What are the main factors influencing future pricing?
Patent expirations, competition, regulatory approvals for new indications, and market demand will influence pricing strategies.
Q4: How significant is the market for Rucaparib globally?
While primarily focused in the U.S. and Europe, expanding access to emerging markets could provide additional growth opportunities, albeit at lower price points.
Q5: What are the prospects for generic versions?
Generic versions are unlikely before 2033, given current patent protections, but legal challenges or patent expiry could accelerate biosimilar entry.
References
- American Cancer Society. (2022). Ovarian Cancer Facts & Figures.
- EvaluatePharma. (2022). Oncology Market Report.
- IQVIA. (2022). Global Oncology Market Insights.
- U.S. Patent and Trademark Office. (2022). Patent Status for Rucaparib.
