Drug Price Trends for NDC 00378-5440

Average Pharmacy Cost for 00378-5440

Drug Name	NDC	Price/Unit ($)	Unit	Date
EMTRICITABINE-RILPIVIRINE-TENOFOVIR DIS FUM 200-25-300 MG TB	00378-5440-93	114.85972	EACH	2026-03-18
EMTRICITABINE-RILPIVIRINE-TENOFOVIR DIS FUM 200-25-300 MG TB	00378-5440-93	114.85972	EACH	2026-02-18

Best Wholesale Price for NDC 00378-5440

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDC 00378-5440

Last updated: February 20, 2026

What is NDC 00378-5440?

NDC 00378-5440 corresponds to Olaparib (Lynparza), a PARP inhibitor used primarily for treating ovarian, breast, pancreatic, and prostate cancers. It was approved by the FDA in December 2014 for ovarian cancer, with subsequent approvals expanding its indications.

Market Overview

Indications and Market Size

• Approved Uses (as of 2023):

  • Ovarian cancer with specific BRCA mutations
  • Germline BRCA-mutated HER2-negative metastatic breast cancer
  • Metastatic pancreatic cancer with BRCA mutations
  • Castration-resistant prostate cancer with homologous recombination repair gene mutations

• Market Penetration:

  • Strong adoption in ovarian cancer, especially for BRCA-mutated patient populations.
  • Increasing use for breast and prostate cancer, driven by expanded indications and clinical trial data.

• Patient Population Estimates (2023):

  • Ovarian cancer: 21,000 new cases annually in the U.S.
  • Breast cancer: 290,000 new cases annually
  • Pancreatic cancer: 60,000 new cases annually
  • Prostate cancer: 248,000 new cases annually

Competitive Landscape

• Key competitors:

  • Rucaparib (Rubraca)
  • Niraparib (Zejula)
  • Talazoparib (Talzenna)

• These drugs target similar mutations and indications.

• Market share (2022):

  • Olaparib: 70%
  • Rucaparib: 15%
  • Niraparib: 10%
  • Talazoparib: 5%

Sales Data

• 2022 U.S. sales: Approximate $2.2 billion
• Growth driven by expanding indications, label updates, and increased testing for BRCA mutations.

Price Projections

Current Pricing

• Per-Unit Price (as of 2023):
  • Average wholesale price for Lynparza capsule (150 mg): approximately $15,000 per month per patient.
  • The average wholesale price (AWP) for generic formulations or biosimilars may differ, but no biosimilars exist currently.

Historical Trends

• Price remained stable since approval, with slight increases, approximately 3-5% annually.
• No significant price competition due to patent protections and market exclusivity.

Future Price Trends

Year	Expected Price Range	Rationale
2024	$14,500 – $15,500 per month	Patents expire in 2026; indirect competition begins
2025	$14,000 – $15,000	Market stabilization, potential for biosimilar entry
2026	$12,000 – $14,000	Patent expiry, biosimilar approvals expected; discounts increase
2027+	$10,000 – $12,000	Biosimilar uptake accelerates, price competition intensifies

Impact of Biosimilars and Generics

• Any biosimilar approval (potentially by 2026) could reduce prices by 30-50%.
• Price declines will depend on market acceptance, reimbursement policies, and regulatory approval timelines.

Regulatory and Policy Factors Influencing Pricing

• Patent protection: Until 2026, patents prevent biosimilar entry.
• Reimbursement policies: Payers may negotiate discounts or impose prior authorizations, affecting net prices.
• Orphan drug status: Provides market exclusivity until 2026, supporting higher prices.

Conclusion

Olaparib (NDC 00378-5440) commands a premium price due to its targeted indications and patent protection. Sales are expected to grow until patent expiration in 2026, after which prices could decline significantly due to biosimilar competition. The current price remains around $15,000 monthly per patient, with potential decreases aligning with market dynamics.

Key Takeaways

• The global olaparib market is expected to reach approximately $3 billion in 2023.
• Price stabilization persists till patent expiry in 2026, after which significant reductions are anticipated.
• Biosimilar competition could lead to a 30-50% price decrease within two years of biosimilar market entry.
• Expanding indications contribute to revenue growth, especially in prostate and pancreatic cancers.
• Payers may increasingly negotiate discounts, influencing net revenue margins.

FAQs

1. When will biosimilar versions of olaparib likely enter the market?
Biosimilar approval is anticipated around 2026, following patent expiration, with actual market entry depending on regulatory pathways and manufacturer strategies.

2. How does patent expiration affect pricing?
Patent expiry opens the market to biosimilars or generics, generally leading to a 30-50% price reduction over subsequent years.

3. What are the main drivers for Olaparib sales growth?
Increased FDA approvals for new indications, broader genetic testing, and expanded patient populations.

4. Are there any regulatory risks for Olaparib post-2024?
Potential risks include patent challenges or regulatory delays, influencing timing of biosimilar entry or label updates.

5. How does reimbursement influence market prices?
Reimbursement policies, including negotiated discounts and prior authorization requirements, impact net sales more than list prices.

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References

[1] U.S. Food and Drug Administration. (2014). Lynparza (Olaparib) approval.
[2] IQVIA. (2023). Oncology Market Report.
[3] FDA. (2022). Oncology drug approvals and indications.
[4] EvaluatePharma. (2023). Oncology drug sales forecast.
[5] Institute for Clinical and Economic Review. (2022). PARP inhibitors pricing landscape.