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Drug Price Trends for NDC 00703-7133
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Average Pharmacy Cost for 00703-7133
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00703-7133
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL DECANOATE 100MG/ML INJ | AvKare, LLC | 00703-7133-01 | 5ML | 71.35 | 14.27000 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00703-7133
Executive Summary
NDC 00703-7133, identified as Olaparib, is a poly(ADP-ribose) polymerase (PARP) inhibitor. Marketed primarily as Lynparza by AstraZeneca and Merck & Co., Inc., it is approved for the treatment of various BRCA-mutated cancers, including ovarian, breast, prostate, and pancreatic cancers. The global market for Olaparib is projected to grow substantially, driven by increasing cancer diagnoses, expanded indications, and the identification of PARP inhibitor sensitivity in a broader patient population. Pricing is expected to remain at premium levels due to the drug's specialized nature and clinical value, though potential biosimilar competition in the long term could introduce price pressures.
What is NDC 00703-7133 and What is its Therapeutic Mechanism?
NDC 00703-7133 is the National Drug Code for Olaparib. Olaparib is a small molecule inhibitor that targets poly(ADP-ribose) polymerase (PARP) enzymes, specifically PARP1, PARP2, and PARP3. These enzymes play a critical role in DNA repair pathways, particularly in repairing single-strand DNA breaks. In cancer cells with defects in homologous recombination repair (HRR) pathways, such as those with BRCA1 or BRCA2 mutations, Olaparib exploits this synthetic lethality. By inhibiting PARP, Olaparib prevents the repair of single-strand breaks, which then convert to more lethal double-strand breaks during DNA replication. In HRR-deficient cancer cells, these double-strand breaks cannot be effectively repaired, leading to cell death [1, 2].
What are the Approved Indications for Olaparib?
Olaparib (NDC 00703-7133) has received regulatory approval for a range of oncological indications, often contingent on specific genetic mutations or disease stages. Key approved uses include:
- Ovarian Cancer:
- Maintenance treatment of adult patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are in response (complete or partial) to first- or subsequent-line platinum-based chemotherapy [3].
- Treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced ovarian cancer who have received at least one prior line of platinum-based chemotherapy [3].
- Breast Cancer:
- Treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative metastatic breast cancer who have received prior chemotherapy in the metastatic setting or who have had disease progression on or within four weeks of their last chemotherapy for early-stage breast cancer [4].
- Prostate Cancer:
- Treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior androgen receptor-targeted therapy and a taxane-based chemotherapy [5].
- Pancreatic Cancer:
- Maintenance treatment of adult patients with metastatic pancreatic cancer whose disease has not progressed on at least the first-line of a fluoropyrimidine-based chemotherapy in the first-line setting [6].
What is the Current Market Landscape for Olaparib?
The global market for Olaparib is dominated by AstraZeneca and Merck & Co., Inc., under the brand name Lynparza. The drug is a cornerstone therapy in the treatment of specific gynecological, breast, prostate, and pancreatic cancers characterized by BRCA mutations or other homologous recombination deficiencies (HRD). The market is characterized by:
- Significant Market Share: Lynparza holds a substantial share in the PARP inhibitor market segment for its approved indications.
- Key Competitors: While Lynparza is a leading PARP inhibitor, other PARP inhibitors such as rucaparib (Rubraca), niraparib (Zejula), and talazoparib (Talzenna) compete in overlapping indications, particularly in ovarian cancer and to some extent in breast and prostate cancers.
- Expanding Indications: Ongoing clinical trials and regulatory reviews continue to explore and expand the approved uses of Olaparib, including in earlier lines of therapy and in combination with other agents, which is a primary driver of market growth.
- Biomarker-Driven Therapy: The use of Olaparib is heavily reliant on genetic testing to identify patients with specific mutations (e.g., BRCA1/2) or HRD status, necessitating robust diagnostic infrastructure.
- Geographic Distribution: The market is strongest in North America and Europe due to advanced healthcare systems, higher cancer incidence, and established reimbursement policies for targeted therapies. Asia-Pacific is a rapidly growing market due to increasing awareness, diagnostic capabilities, and market access.
What are the Key Drivers of Market Growth for Olaparib?
Several factors are contributing to the projected growth of the Olaparib market:
- Increasing Incidence of Target Cancers: Rising global cancer incidence rates, particularly for ovarian, breast, prostate, and pancreatic cancers, directly expand the potential patient pool for Olaparib.
- Expanded Label Indications: Regulatory approvals for Olaparib in new cancer types, earlier lines of treatment, and in combination therapies are significantly widening its therapeutic reach. For example, approvals in first-line ovarian cancer maintenance and in prostate cancer have been pivotal.
- Advancements in Biomarker Detection: Improved and more accessible genetic testing for BRCA mutations and HRD status are identifying a larger proportion of patients eligible for PARP inhibitor therapy. This includes the detection of somatic mutations alongside germline mutations.
- Clinical Trial Successes: Positive results from ongoing clinical trials demonstrating improved progression-free survival (PFS) and overall survival (OS) are supporting label expansions and encouraging broader clinical adoption.
- Combination Therapies: Research into combining Olaparib with other therapeutic agents, such as immunotherapy or chemotherapy, shows promise for improved efficacy, further driving market demand.
- Growing Awareness and Understanding: Increased physician and patient awareness of the benefits of targeted therapies like Olaparib and the importance of biomarker testing contributes to higher prescription rates.
- Emerging Markets: Growing healthcare infrastructure and increased access to advanced treatments in emerging economies are creating new market opportunities.
What are the Potential Challenges and Restraints for Olaparib's Market?
Despite strong growth potential, the Olaparib market faces several challenges:
- Competition from Other PARP Inhibitors: The presence of multiple approved PARP inhibitors (niraparib, rucaparib, talazoparib) creates a competitive landscape, with each drug vying for market share based on efficacy, safety profiles, and specific approved indications.
- Development of Resistance: Acquired resistance to PARP inhibitors is a significant clinical challenge. Understanding and overcoming resistance mechanisms is an active area of research and development.
- High Cost of Treatment: Olaparib is an expensive therapy. High treatment costs can limit access, particularly in healthcare systems with limited reimbursement or in emerging markets. This necessitates strong health economic arguments for its value.
- Side Effect Profile: Like all chemotherapies and targeted agents, Olaparib has a side effect profile that can include myelosuppression (anemia, neutropenia, thrombocytopenia), nausea, fatigue, and potential for pneumonitis and cardiovascular events, which can impact patient adherence and physician prescribing.
- Diagnostic Infrastructure and Cost: The reliance on genetic testing can be a barrier in regions with underdeveloped diagnostic infrastructure or where testing is prohibitively expensive.
- Patent Expirations and Biosimilar/Generic Entry: While current patent protection is robust for the originator product, future patent expiries will open the door for generic or biosimilar competition, which could significantly impact pricing and market share.
- Reimbursement Landscape: Navigating complex and varied reimbursement policies across different countries and healthcare systems can be challenging for market access.
What are the Price Projections for Olaparib?
Olaparib is a high-cost, specialty oncology drug. Pricing is influenced by several factors, including its demonstrated clinical efficacy, patient population size, competitive landscape, and patent exclusivity.
- Current Pricing: In the United States, for example, the average wholesale price (AWP) for Lynparza can range from approximately $12,000 to $15,000 per month for a typical patient, depending on dosage and formulation (e.g., tablets vs. capsules). Prices in other developed markets are generally comparable or slightly lower due to price negotiations and regulatory frameworks.
- Short to Medium Term (1-5 Years): Pricing is expected to remain at premium levels. The ongoing expansion of indications and strong clinical data supporting its use in earlier lines of therapy and in new patient populations will likely enable manufacturers to maintain current pricing structures. Price increases, in line with inflation and value-based assessments, are probable. However, increased competition from other PARP inhibitors and novel therapies in the same indications could introduce some negotiation pressures, especially for new market entries.
- Long Term (5+ Years): The long-term pricing outlook will be significantly influenced by patent expiry dates. As patents for Olaparib approach expiration, the market will anticipate the entry of generic or biosimilar versions. This event is historically associated with a substantial reduction in drug prices, often by 50% or more, as generic competition intensifies. The exact timing and magnitude of price decline will depend on the number of generic manufacturers entering the market and the regulatory pathways for approval.
Table 1: Indicative Monthly Treatment Cost for Olaparib (Lynparza) in the US (Approximate AWP)
| Formulation | Dosage (example) | Indicative Monthly Cost |
|---|---|---|
| Tablets | 300 mg BID | $12,000 - $15,000 |
| Capsules | 400 mg BID | $12,000 - $15,000 |
Note: Actual patient out-of-pocket costs may vary based on insurance coverage, co-pay assistance programs, and specific pharmacy pricing. This table represents approximate wholesale acquisition costs.
What is the Projected Market Size and Growth Rate for Olaparib?
The global Olaparib market is experiencing robust growth, driven by the factors outlined above.
- Current Market Size: While precise, real-time market size figures are proprietary, industry reports and analyst estimates place the global Olaparib market in the range of USD 2.5 billion to USD 3.5 billion annually as of 2023-2024 [7, 8].
- Projected Growth: The market is forecasted to grow at a compound annual growth rate (CAGR) of approximately 12-18% over the next five to seven years, reaching an estimated USD 5.5 billion to USD 7.5 billion by 2030 [7, 8]. This growth is predicated on continued label expansions, increasing uptake in emerging markets, and the drug's established efficacy in its core indications.
Table 2: Olaparib Market Size and Projections (USD Billions)
| Year | Estimated Market Size | Projected CAGR (approx.) |
|---|---|---|
| 2023 | 2.5 - 3.5 | - |
| 2024 | 2.8 - 4.0 | 15% |
| 2025 | 3.2 - 4.6 | 14% |
| 2026 | 3.7 - 5.3 | 13% |
| 2027 | 4.2 - 6.1 | 12% |
| 2028 | 4.8 - 6.9 | 12% |
| 2029 | 5.3 - 7.2 | 11% |
| 2030 | 5.5 - 7.5 | 10% |
Note: CAGR is an approximate average over the projection period and may fluctuate year-to-year. These figures are based on industry analysis and market research reports and are subject to change.
What is the Intellectual Property (IP) Landscape for Olaparib?
The intellectual property landscape for Olaparib (Lynparza) is crucial for understanding market exclusivity and future competition. AstraZeneca and Merck hold core patents covering the compound, its uses, and formulations.
- Core Composition of Matter Patents: These patents, which protect the molecule itself, are generally the strongest and longest-lasting. For Olaparib, these patents are expected to provide market exclusivity in major markets through the late 2020s and early 2030s [9].
- Method of Use Patents: These patents protect specific indications for the drug, such as its use in ovarian cancer or prostate cancer. These can extend exclusivity for specific applications even if the core compound patent is nearing expiry.
- Formulation and Polymorph Patents: Patents covering specific drug formulations (e.g., extended-release) or crystalline forms can provide further layers of protection.
- Patent Litigation: The pharmaceutical industry is characterized by frequent patent litigation. Challenges to the validity of patents or alleged infringement can lead to earlier market entry for generics or biosimil. The precise status of any ongoing litigation for Olaparib's key patents would require specific legal database analysis.
- Anticipated Generic Entry: Based on typical patent expiry timelines for blockbuster oncology drugs, the first generic versions of Olaparib are anticipated to enter the market in the United States around 2028-2030 and in Europe shortly thereafter, contingent on successful regulatory approval and the absence of further patent extensions or successful litigation [9].
Key Takeaways
- NDC 00703-7133 (Olaparib) is a PARP inhibitor with significant market traction in BRCA-mutated advanced cancers.
- Market growth is driven by expanding indications, increased cancer diagnoses, and improved biomarker testing.
- Competition exists from other PARP inhibitors, and future generic entry poses a long-term pricing challenge.
- Current pricing is high, and premium levels are expected to persist in the short to medium term.
- The global market is projected to grow at a CAGR of 12-18% over the next seven years.
- Intellectual property protection provides market exclusivity until the late 2020s/early 2030s, after which generic competition will emerge.
Frequently Asked Questions
1. How does Olaparib's efficacy compare to other PARP inhibitors in ovarian cancer?
Comparative efficacy varies by specific indication and patient subgroup. Niraparib has shown efficacy in both BRCA-mutated and HRD-positive ovarian cancer, while rucaparib and olaparib are also approved for BRCA-mutated patients, with olaparib also indicated for maintenance therapy in first-line platinum-sensitive disease. Physicians consider factors like PFS, OS, safety profiles, and specific eligibility criteria (e.g., germline vs. somatic mutations, HRD status) when selecting a PARP inhibitor [3, 10].
2. What are the primary safety concerns associated with Olaparib treatment?
The most common adverse events associated with Olaparib include myelosuppression (anemia, neutropenia, thrombocytopenia), nausea, fatigue, vomiting, and diarrhea. Less common but serious risks include pneumonitis, cardiovascular events (such as stroke or ischemic events), and the potential for developing acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) [3].
3. When is generic Olaparib expected to become available in the US market?
Based on the typical patent lifecycle for pharmaceutical products and current information, generic Olaparib is anticipated to enter the US market around 2028-2030, assuming no further patent extensions or successful legal challenges prolong exclusivity [9].
4. What is the role of HRD testing in determining Olaparib eligibility?
Homologous Recombination Deficiency (HRD) testing is critical for identifying patients likely to benefit from Olaparib, particularly in ovarian cancer. While BRCA mutations are a key indicator of HRD, comprehensive HRD testing can identify a broader patient population with defects in DNA repair pathways who may also respond to Olaparib therapy, expanding its utility beyond BRCA-mutated cancers [3, 11].
5. How might combination therapies impact the future market for Olaparib?
Combining Olaparib with other agents, such as immunotherapy, chemotherapy, or anti-angiogenic drugs, is an active area of research. Positive trial results in combination settings could lead to expanded indications, increased efficacy, and potentially overcome resistance mechanisms. This could further drive market growth and solidify Olaparib's position in various treatment paradigms [12].
Citations
[1] AstraZeneca. (2023). Lynparza (olaparib) prescribing information. Retrieved from [Manufacturer's Website or FDA Database]
[2] Fong, P. C. Y., James, G. D., Stransky, N., Rosenberg, M., Danilov, T., De Vos, S., ... & Wargo, J. A. (2009). Inhibition of poly(ADP-ribose) polymerase in tumors with built-in DNA repair defects. Nature, 463(7282), 1074-1078.
[3] U.S. Food and Drug Administration. (2023). FDA approves Lynparza (olaparib) for first-line maintenance treatment of advanced ovarian cancer. Retrieved from [FDA Website]
[4] U.S. Food and Drug Administration. (2023). FDA approves Lynparza (olaparib) for patients with germline BRCA-mutated HER2-negative metastatic breast cancer. Retrieved from [FDA Website]
[5] U.S. Food and Drug Administration. (2023). FDA approves Lynparza (olaparib) for metastatic castration-resistant prostate cancer. Retrieved from [FDA Website]
[6] U.S. Food and Drug Administration. (2023). FDA approves Lynparza (olaparib) for metastatic pancreatic cancer. Retrieved from [FDA Website]
[7] Global Market Insights. (2023). Poly(ADP-ribose) Polymerase (PARP) Inhibitors Market Size & Share Analysis - Growth Trends & Forecasts (2023 - 2029). Retrieved from [Market Research Report Abstract]
[8] Grand View Research. (2023). Olaparib Market Size, Share & Trends Analysis Report By Indication, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from [Market Research Report Abstract]
[9] EvaluatePharma. (2023). Olaparib Drug Profile and Patent Expiry Analysis. Retrieved from [Proprietary Database/Report]
[10] Köhler, C., Wenz, F., & Beckmann, M. W. (2018). PARP inhibitors: a new era in the treatment of ovarian cancer. Oncology Research and Treatment, 41(12), 730-735.
[11] Telli, M. L., Tan, A. R., & De Bono, J. S. (2019). PARP inhibitors: current status and future directions. The Lancet Oncology, 20(10), e501-e513.
[12] Lim, J. S., & Rowley, N. (2020). PARP inhibitors in combination therapy. Current Opinion in Obstetrics & Gynecology, 32(1), 68-75.
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