Last updated: February 14, 2026
What is NDC 50742-0112?
The National Drug Code (NDC) 50742-0112 identifies a specific drug product. According to the FDA’s NDC directory and manufacturer data, this code corresponds to Olaparib (Lynparza), 150 mg tablets, manufactured by AstraZeneca. Olaparib is a PARP inhibitor used primarily for certain ovarian, breast, pancreatic, and prostate cancers.
Market Overview
Indications and Approved Uses
Olaparib holds FDA approval for multiple cancer indications:
-Ovarian Cancer: Maintenance therapy for BRCA-mutated, platinum-sensitive recurrent ovarian cancer (approved since 2018).
-Breast Cancer: Metastatic HER2-negative, germline BRCA-mutated HER2-negative breast cancer (approved since 2018).
-Pancreatic Cancer: Maintenance in germline BRCA-mutated metastatic pancreatic adenocarcinoma (approved in 2019).
-Prostate Cancer: Treatment for metastatic castration-resistant prostate cancer with homologous recombination repair gene mutations (approved in 2020).
Market Penetration and Competitors
Olaparib is a first-in-class PARP inhibitor with a growing market share, owing to its expanding indications. Major competitors include:
- Rucaparib (Rubraca): Approved for ovarian and prostate cancers.
- Niraparib (Zejula): Primarily ovarian cancer.
- Talazoparib (Talzenna): Breast and ovarian cancers.
Market Size
- In 2022, the global PARP inhibitor market was valued at approximately USD 3 billion.
- The U.S. accounted for nearly 75% of that value.
- The FDA-approved indications for olaparib are estimated to reach a cumulative patient population of 75,000–100,000 in the U.S.
Pricing Analysis
Average Wholesale Price (AWP) and List Prices
- The indicated dosage for olaparib is 150 mg tablets.
- The average wholesale price (AWP) per 150 mg tablet ranges from USD 80 to USD 100.
- The typical regimen involves two tablets twice daily, totaling four tablets per day.
Annual Cost Projections
| Parameter |
Calculation |
Estimated Annual Cost |
| Tablets per day |
4 |
4 |
| Tablets per month |
120 |
120 |
| Cost per tablet |
USD 90 |
|
| Monthly cost |
USD 1080 |
USD 1080 |
| Annual cost |
USD 12,960 |
USD 12,960 |
Pricing Trends
- Price reductions are expected as biosimilar and generic versions enter select markets, though biosimilars are less relevant for Olaparib due to its novel biological origin.
- The current pricing for brand-name olaparib remains stable owing to patent protection and exclusivity periods expiring in 2029.
Patent and Exclusivity Landscape
Patent Protection
- AstraZeneca holds patents extending into 2029.
- Orphan drug exclusivity expired in 2022 for certain indications, but market exclusivity remains due to patent protection.
Impacts on Pricing and Competition
- Patent protection limits generic competition until 2029.
- Regulatory exclusivity maintains the brand price premium.
Price Projections for 2023–2028
Short-Term (2023-2025)
- Prices maintain current levels due to patent protections.
- Annual treatment cost remains near USD 13,000.
- Minor discounts and rebate programs could reduce patient out-of-pocket costs by 10-20%.
Medium-Term (2026-2028)
- Price may stabilize or slightly decline by 5-10% as payers leverage negotiated rebates.
- Entry of potential biosimilars or new competitors could lower net prices marginally.
Long-Term (Post-2029)
- Patent expiry expected around 2029 could lead to generic competition.
- Price declines of 40-60% anticipated post-patent expiry, based on historical precedents for cancer biologics.
Regulatory and Reimbursement Outlook
- The drug is covered under Medicare, Medicaid, and private insurance plans.
- Rebate programs and tiered formulary placement influence patient access and out-of-pocket costs.
- Price negotiations and value-based contracting may influence pricing dynamics, especially in Medicare.
Key Takeaways
- NDC 50742-0112 (olaparib 150 mg tablets) operates in a multi-billion-dollar global oncology market.
- The drug's current price is approximately USD 13,000 annually per patient, with margins protected by patent exclusivity until 2029.
- Market expansion is driven by approved new indications and rising patient populations with homologous recombination repair gene mutations.
- Long-term price projections depend heavily on patent expiration and market entry of biosimilars or generics.
- Reimbursement strategies will influence net prices and patient access, with payers negotiating rebates, discounts, and prior authorizations.
FAQs
1. When does the patent protection for olaparib expire?
Patent protection is expected to expire around 2029, though some secondary patents may extend exclusivity.
2. How does the price of olaparib compare to other PARP inhibitors?
It is generally comparable in list price to other branded PARP inhibitors like rucaparib and niraparib, which range from USD 12,000 to USD 15,000 annually.
3. Are biosimilars or generics available for olaparib?
No. As a biologic-based drug, biosimilars are less likely for olaparib until patent expiry. Generic versions are unlikely before 2029.
4. What factors could influence olaparib’s future price?
Patent expiration, competition from biosimilars or new inhibitors, regulatory changes, and payer negotiations.
5. How significant is the market potential for olaparib?
The potential patient population exceeds 75,000 in the U.S., with global sales expected to grow due to new indications and increasing cancer diagnosis rates.
References
- FDA Orange Book, 2023.
- AstraZeneca Annual Reports, 2022.
- MarketWatch, "PARP Inhibitors Market Size," 2022.
- IQVIA Data, 2022.
- U.S. Patent and Trademark Office, Patent Expiry Database.
