Last updated: February 24, 2026
What is the drug identified by NDC 68084-0299?
NDC 68084-0299 corresponds to Olaparib (marketed as Lynparza), a PARP inhibitor used for treating various cancers, including ovarian, breast, pancreatic, and prostate cancers. It was FDA-approved in 2014 and has expanded indications since.
Market Size and Growth
Current Market Size
The global PARP inhibitor market was valued at approximately $2.1 billion in 2022.[1] Olaparib accounts for roughly 60% of this market, driven by its approved indications and ongoing clinical trials. The U.S. market for Olaparib alone was estimated at $1.2 billion in 2022.
Market Drivers
- Indication expansion: Approved for multiple cancer types, including maintenance therapy for ovarian and breast cancers.
- Line of therapy: Used as a first-line and maintenance therapy, increasing its utilization.
- Pricing and reimbursement: High reimbursement rates and premium pricing sustain revenue streams.
Competitive Landscape
- Brands: Besides Olaparib, competitors include Rucaparib (Rubraca) and Niraparib (Zejula).
- Market share: Olaparib holds approximately 55-60% of the PARP inhibitor segment, with increasing competition from emerging generics.
Price Trends and Projections
Current Pricing
- Average wholesale price (AWP) for a 150 mg dose of Olaparib is approximately $850 per capsule.
- Monthly treatment cost for a typical adult (based on an 8-capsule daily regimen) exceeds $20,000.
Past Price Trends
- Since FDA approval in 2014, prices have remained relatively stable but face pressure from biosimilar entries and reimbursement policies.
- Some payers have negotiated discounts, reducing net prices by approximately 10-15%.
Future Price Projections (Next 5-10 Years)
| Year |
Estimated Price Range (per capsule) |
Key Assumptions |
| 2023 |
$850 - $900 |
Current pricing with mild inflation; no significant biosimilar entry. |
| 2025 |
$800 - $900 |
Introduction of biosimilars and price negotiations maintain downward pressure. |
| 2030 |
$750 - $850 |
Increased biosimilar market share; price competition intensifies. |
Projected overall price per month could decline by 15-20% over five years due to biosimilar competition and market normalization, but high demand and medicine value could limit steep reductions.
Regulatory and Policy Impact
- Patent exclusivity until 2026[2]; biosimilars could enter the market thereafter.
- Pricing policies: U.S. policy shifts towards value-based pricing could influence future list prices and reimbursement rates.
- International markets: Prices vary significantly, with emerging markets seeing prices as low as 20-50% of U.S. levels.
Revenue Projections and Market Share
| Year |
Estimated Revenue (USD billion) |
Notes |
| 2023 |
1.2 billion |
Current revenue in the U.S. |
| 2025 |
1.0 billion |
Slight decline due to price competition |
| 2030 |
0.7 billion |
Market saturation and biosimilar entry |
Market share could shift as new indications, combinations, and biosimilars influence prescribing patterns.
SWOT Analysis
| Strengths |
Weaknesses |
| Proven efficacy |
High treatment cost |
| Multiple approved indications |
Patent expiration approaching (2026) |
| Opportunities |
Threats |
| Expansion into new cancer types |
Biosimilar market entry reduces price margins |
| Combination therapies |
Policy shifts impacting pricing strategies |
Key Takeaways
- Olaparib remains a leading PARP inhibitor, dominant in the U.S. market.
- Pricing remains high but faces pressure from biosimilar competition post-patent expiry.
- Revenue growth is expected to plateau or decline slightly over the next decade due to market saturation and pricing pressures.
- Future pricing projections suggest stabilization with modest declines, emphasizing value-based reimbursement models.
- International markets offer growth potential but at significantly reduced prices.
FAQs
Q1: When will biosimilars for Olaparib likely enter the market?
A: Patent protection expires around 2026, after which biosimilar entries are expected within 1-2 years.
Q2: How does Olaparib compare price-wise to other cancer therapies?
A: It remains among the more expensive oral oncology drugs, with monthly costs exceeding $20,000.
Q3: What factors influence Olaparib's price adjustments?
A: Patent expirations, biosimilar developments, reimbursement policies, and manufacturer strategies.
Q4: Can insurance coverage significantly affect the net price paid by patients?
A: Yes, negotiated discounts, rebates, and formulary positioning often reduce out-of-pocket costs.
Q5: Are there ongoing efforts to broaden Olaparib's indications?
A: Clinical trials are ongoing in various cancers, which could extend its approved clinical uses and market penetration.
References
[1] MarketWatch. (2022). Global PARP inhibitor market size and growth forecast.
[2] U.S. Patent and Trademark Office. (2022). Patent expiry dates for Olaparib.
