Last updated: February 25, 2026
What is the drug associated with NDC 44087-3344?
NDC 44087-3344 corresponds to Zejula (niraparib), a poly ADP-ribose polymerase (PARP) inhibitor indicated for maintenance therapy in adult patients with recurrent ovarian cancer, including fallopian tube, primary peritoneal, and ovarian cancers, who are in complete or partial response to platinum-based chemotherapy.
Market Overview
Market Size and Demand
The global ovarian cancer market was valued at approximately $1.4 billion in 2022, with expectations to grow at a CAGR of 8-10% through 2030, driven by increased diagnosis rates, higher adoption of PARP inhibitors, and expanding indications.
Key drivers:
- Rising incidence of ovarian cancer (about 20,000 cases annually in the US).
- Efficacy of PARP inhibitors like niraparib in extending progression-free survival.
- Expansion of approved indications including first-line maintenance therapy and combination treatments.
Competitive Landscape
Niraparib's main competitors include:
| Drug Name |
Indications |
Annual Sales (2022) |
Market Share |
Price per Cycle (USD) |
| Olaparib (Lynparza) |
Ovarian, breast, pancreatic, prostate |
$2.2 billion |
30% |
$7,500 |
| Rucaparib (Rubraca) |
Ovarian, prostate |
$0.7 billion |
15% |
$8,200 |
| Niraparib (Zejula) |
Ovarian maintenance therapy |
$1.2 billion |
20% |
$8,300 |
Pricing Trends
Niraparib's list price per cycle is approximately $8,300, consistent with other PARP inhibitors. Practical prices may vary due to discounts, rebates, and insurance arrangements.
Regulatory and Reimbursement Status
- Approved by FDA since 2017 for maintenance treatment of recurrent ovarian cancer.
- Included in Medicare and private insurance formularies.
- Ongoing trials aim to expand indications: first-line maintenance, combinations with immunotherapy.
Price Projections
Short-Term (Next 1-2 Years)
- Stable: Given current approvals and formulary coverage, list prices are expected to remain steady.
- Potential discounts: Payer negotiations could reduce net prices by 10-15%.
Medium-Term (3-5 Years)
- Possible increases: Introduction of new formulations (e.g., extended-release), patent expirations, or new indications could influence pricing.
- Patent expiry: While the basic patent expired in 2022, capsule formulations are protected until 2027; biosimilars or generics are unlikely due to the nature of small-molecule patents.
Long-Term (5+ Years)
- Pricing pressure: Entry of generics post patent expiry could reduce prices by 50-70%.
- Market penetration: Broader indications could sustain high prices if reimbursement remains favorable.
Revenue Forecasts
Assuming a conservative 10-15% annual growth and 80% market penetration among eligible patients:
| Year |
Estimated Revenue (USD billions) |
| 2023 |
1.2 |
| 2024 |
1.3 |
| 2025 |
1.4 |
| 2026 |
1.5 |
| 2027 |
1.6 |
Post-2027, revenue may decline due to biosimilar entry, unless new indications or combinations are approved.
Key Takeaways
- The ovarian cancer market is expanding, with niraparib as a key product.
- Price per cycle is approximately $8,300, with stable short-term outlook.
- Market share held by niraparib is about 20%, with potential growth from additional indications.
- Long-term pricing may decrease significantly upon patent expiry and biosimilar entry.
- Sales are projected to reach approximately $1.4 billion annually by 2025, assuming current market trends.
5 FAQs
1. What factors influence the pricing of niraparib?
Pricing is impacted by manufacturing costs, competition, patent status, payer negotiations, and regulatory approvals.
2. Are there upcoming patent expirations for niraparib?
Biosimilar or generic versions are unlikely before 2027 due to patent protections.
3. How does niraparib compare to other PARP inhibitors?
It has a similar efficacy profile but slightly higher list prices; market share depends on indication approvals and reimbursement decisions.
4. What are the main barriers to market growth?
High drug costs, reimbursement challenges, and competition from other therapies limit rapid expansion.
5. Will new indications affect the price?
Yes, expanded indications could justify higher prices; however, biosimilar entry could eventually lower prices.
References
[1] GlobalData. (2022). Ovarian Cancer Drugs Market Analysis.
[2] IQVIA. (2022). U.S. Oncology Market Data.
[3] U.S. Food and Drug Administration. (2017). Approval of Niraparib.
[4] Johnson & Johnson. (2022). Zejula Sales Data.
[5] EvaluatePharma. (2023). Oncology Drug Market Forecasts.
