Last updated: February 15, 2026
What is the drug with NDC 42571-0220?
NDC 42571-0220 corresponds to Zejula (niraparib). It is an oral PARP inhibitor used to treat ovarian, fallopian tube, and primary peritoneal cancers, primarily in patients with BRCA mutations or homologous recombination deficiency (HRD).
Current Market Overview
Market Approval and Indications:
- Approved by the FDA in March 2017 for maintenance therapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer.
- Approved in multiple regions including the U.S., Europe, and Japan.
- Used mainly in combination with other chemotherapeutic agents or as a standalone maintenance therapy after response to platinum-based chemotherapy.
Sales and Revenue Trends:
- U.S. sales in 2022 reached approximately $500 million.
- Global sales are estimated at over $1 billion, with North America accounting for roughly 70% of the revenues.
- sales growth driven by expanded indications and increased adoption in treatment protocols.
Market Share and Competitors:
- Market share: Zejula holds approximately 30% of the PARP inhibitor market in ovarian cancer.
- Main competitors include Lynparza (olaparib) from AstraZeneca and Rubraca (rucaparib) from Clovis Oncology.
- Lynparza dominates with over 50% market share; Zejula's growth hinges on expanding indications and payer access.
Pricing Landscape:
- Average wholesale price (AWP): approximately $12,500 per 30-day supply.
- Net price varies based on discounts, rebates, and formulary negotiations.
- Payer coverage has improved since launch, but access barriers remain.
Market Dynamics & Drivers
- Increase in ovarian cancer incidence, especially among women aged 55–75.
- Growing adoption of PARP inhibitors as standard maintenance therapy following robust clinical trial data.
- Expanded label indications, including first-line maintenance settings.
- Patient access programs and biosimilar development may influence pricing and competition.
Pricing & Revenue Projections (Next 5 Years)
| Year |
Estimated Global Sales |
Assumptions |
Notes |
| 2023 |
$1.2 billion |
Mature FDA approvals, stable market share, inflation |
Growth driven by expanding indications, price stability |
| 2024 |
$1.3 billion |
Slight market penetration in Europe and Asia |
Continued adoption, payer negotiations |
| 2025 |
$1.4 billion |
New indications, biosimilar potential limiting price hikes |
Increased competition, patent life considerations |
| 2026 |
$1.4 billion |
Market saturation, legal challenges to patent enforcement |
Biosimilar entries beginning, price competition |
| 2027 |
$1.2 billion |
Biosimilar availability, payer pressure, safety concerns |
Price erosion, market consolidation |
Factors Impacting Pricing & Market Share
- Patent Expiry: Patent protection extending into 2028, with biosimilar development potential.
- Regulatory Approvals: Additional approvals for frontline treatment expected into the next 2–3 years.
- Reimbursement Policies: Payer coverage expanding but with potential formulary restrictions.
- Competitive Landscape: Lynparza's broader indications could pressure Zejula’s growth.
- Manufacturing & Supply Chain: Stable supply chain essential for sustaining market share.
Key Strategic Considerations
- Diversification into combination therapies may unlock new revenue streams.
- Price adjustments tied to market competition, especially biosilimar entries.
- Invest in expanding indications and geographic reach, notably in Asia.
- Monitor emerging data on efficacy and safety to sustain payer confidence.
Key Takeaways
- Zejula (niraparib) maintains a leading position in the ovarian cancer PARP inhibitor market with global sales surpassing $1 billion in 2022.
- Price projections suggest growth to approximately $1.4 billion by 2025, followed by potential decline due to biosimilar competition.
- Market dynamics favor continued adoption owing to expanding indications but are tempered by patent expiration and increased competition.
- Price points align with other PARP inhibitors, with ongoing negotiations influencing net pricing.
- Strategic focus on expanding indications and geographic markets is critical to maintaining growth.
FAQs
1. What factors could cause Zejula's price to decline in the next 3–5 years?
Patent expiration, biosimilar development, aggressive payer negotiations, and increased competition from other PARP inhibitors.
2. How does Zejula compare with competitors like Lynparza?
Zejula generally has a comparable efficacy profile but has a narrower indication scope. Lynparza holds a larger market share due to broader approvals.
3. What are the main indications driving Zejula sales?
Maintenance therapy in recurrent ovarian cancer, especially in patients with BRCA mutations or HRD-positive tumors.
4. How does geographic expansion influence Zejula's price?
Market entry into emerging markets like China and India could lead to lower price points but increase overall sales volume.
5. What are the risks associated with Zejula's future market share?
Patent challenges, biosimilar competition, regulatory setbacks, and adverse safety data could impact sales trajectory.
Sources:
- IQVIA sales data 2022.
- FDA approvals and label expansions (FDA.gov).
- Market intelligence reports from EvaluatePharma.
- Pricing data from Red Book and CMS databases.
- Competitive analysis reports from GlobalData.
