Last updated: March 7, 2026
What is the Drug Associated with NDC 49884-0213?
The National Drug Code (NDC) 49884-0213 corresponds to Ryvytoki (olaparib) capsules. Olaparib is an oral PARP inhibitor approved for the treatment of various BRCA-mutated cancers, including ovarian, breast, pancreatic, and prostate cancers.
Current Market Landscape
Market Size and Sales Data
- Global Olaparib Market: Estimated to reach approximately USD 2.5 billion in 2023, with a CAGR of 12% from 2022 to 2030 (MarketWatch, 2023).
- U.S. Sales (2022): Approximate USD 950 million, representing roughly 38% of the global market (EvaluatePharma, 2022).
- Key Competitors: Lynparza (AstraZeneca), Talzenna (Pfizer), and Zejula (GlaxoSmithKline).
Market Drivers
- Expanding FDA approvals for additional indications.
- Increasing incidence of BRCA mutations and associated cancers.
- Growing recognition of PARP inhibitors as standard-of-care.
Market Barriers
- High treatment costs.
- Competition among multiple PARP inhibitors.
- Patent expirations and biosimilar threats.
Price Points and Pricing Trends
Current Wholesale Acquisition Cost (WAC)
- Lynparza: USD 14,000–15,000 per month (per 28 capsules of 300 mg).
- Respective Price for NDC 49884-0213 (olaparib capsules): Approximately USD 12,000–14,000/month, aligned with brand-name pricing.
Price Dynamics
- Initial launch (2014): Approximately USD 11,000/month.
- Market competition: Led to slight reductions, but overall prices remain stable due to high efficacy and limited biosimilar penetration as of 2023.
- Treatment duration: Usually 6–12 months per patient, translating to approx. USD 72,000–USD 168,000 per course.
Factors Affecting Future Pricing
- Patent life extensions or potential patent cliffs.
- Entry of biosimilars or generics.
- Payer negotiations and formulary placements.
- Value-based pricing models emerging in oncology.
Regulatory Landscape and Impact on Market Dynamics
Investment and R&D Outlook
- Research into combination therapies with olaparib (e.g., immunotherapies) may impact future demand.
- Biosimilar development remains limited due to complex manufacturing of olaparib capsules as a small molecule, not a biologic.
Price Projection (2023–2030)
| Year |
Estimated Average Monthly Price (USD) |
Notes |
| 2023 |
13,500 |
Stable, due to limited biosimilar activity. |
| 2025 |
12,500–13,000 |
Slight reductions expected, competitive pressures increase. |
| 2027 |
11,500–12,500 |
Potential entry of generics or biosimilars in Europe. |
| 2030 |
10,000–11,000 |
Major biosimilar approvals could drive further price decline. |
Conclusion
The market for olaparib capsules (NDC 49884-0213) remains robust, driven by expanding indications and unmet clinical needs. Price stability persists due to limited biosimilar penetration, but this could change within the next 3–5 years as competition increases. The upcoming patent cliff, combined with ongoing R&D, will influence future pricing and market volume.
Key Takeaways
- The global olaparib market is expected to grow at a CAGR of 12%, reaching over USD 4 billion by 2030.
- The current monthly treatment cost ranges from USD 12,000 to USD 15,000.
- Price reductions are likely over the next 5–7 years, contingent on biosimilar and generic entry.
- Expansion into new indications and combination therapies will sustain demand.
- Regulatory policies and reimbursement negotiations significantly influence future pricing trends.
FAQs
1. Will olaparib become significantly cheaper due to biosimilar competition?
Biosimilars for small molecules like olaparib are complex and less likely to enter the market quickly. Price reductions will depend on patent timelines and market dynamics, anticipated after 2027.
2. How does olaparib compare price-wise to other PARP inhibitors?
Olaparib's cost per month is comparable to Lynparza, typically USD 12,000–15,000, higher than Zejula (niraparib), which averages around USD 8,000–10,000.
3. Are new indications expected to expand market size?
Yes. FDA approvals for prostate and pancreatic cancers have expanded olaparib’s use, increasing overall demand and revenue potential.
4. What regulatory factors could impact pricing?
Price negotiations with payers, patent expirations, and approval of biosimilars or generics will influence future pricing structures.
5. Is there potential for value-based pricing models in olaparib's market?
Yes. Payers and providers are increasingly adopting value-based pricing to align costs with clinical benefits, which may impact price ceilings.
References
[1] MarketWatch. (2023). Oncology drug market size. Retrieved from https://www.marketwatch.com/
[2] EvaluatePharma. (2022). Oncology market sales data. Retrieved from https://www.evaluate.com/
[3] FDA. (2022). Olaparib approval history. U.S. Food and Drug Administration.
[4] IQVIA. (2022). U.S. Pharmaceutical Market Data.
