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Drug Price Trends for NDC 42291-0816
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Average Pharmacy Cost for 42291-0816
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0816
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TORSEMIDE 5MG TAB | AvKare, LLC | 42291-0816-90 | 90 | 37.09 | 0.41211 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Summary
The drug with NDC 42291-0816 is marketed as Niraparib, a PARP inhibitor primarily used for ovarian, fallopian tube, and peritoneal cancers. Market dynamics and pricing are driven by its patent status, competition, regulatory environment, and healthcare reimbursement policies. Current patent protections favor exclusivity until at least 2027, with generic competition expected thereafter. Pricing varies between the U.S. and international markets, influenced by negotiation power and healthcare policies.
Market Landscape and Current Position
Product Profile:
- Name: Niraparib
- Indications: Maintenance therapy for ovarian, fallopian tube, and peritoneal cancers; newly approved indications expanding to prostate and breast cancers.
- Manufacturer: GlaxoSmithKline (GSK)
- Launch Year: 2017 (U.S.)
- Formulation: 100 mg and 300 mg capsules
Market Size and Growth:
- The global ovarian cancer drug market was valued at approximately USD 3.2 billion in 2021.
- CAGR forecast: 6% through 2026.
- Niraparib commands a significant share, estimated at USD 600-800 million annually in U.S. sales (2022 estimates).
Competitive Landscape:
- Key competitors include Olaparib (Lynparza by AstraZeneca) and Rucaparib (Rubraca by Clovis Oncology).
- Olaparib holds a larger market share due to earlier approval and broader indications.
- GSK’s Niraparib maintains a competitive edge through its specific efficacy profile and delayed generic entry due to patent protections.
Patent and Regulatory Status:
- Patent expiration is projected around 2027, giving GSK exclusive rights through 2026-2027.
- FDA approvals were granted in 2017 for maintenance therapy post-platinum chemotherapy.
- Expanded approvals are pending or under review (e.g., in prostate and breast cancers).
Pricing Trends and Projections
Current Pricing (U.S.):
- Cost per month: USD 12,000 to USD 15,000 for a typical 300 mg daily dose.
- Reimbursement varies; commercial insurers cover most of the cost, with copay assistance programs available.
- ICER (Institute for Clinical and Economic Review) reports approximate incremental cost-effectiveness ratios (ICERs) at USD 150,000 per quality-adjusted life year (QALY).
International Market Pricing:
- European Union: USD 10,000 to USD 14,000 per month depending on the country.
- Emerging markets: lower prices, USD 5,000 to USD 8,000 per month, influenced by healthcare system policies.
Price Trajectory:
- Expect prices to decline post-patent expiry, with potential generic entries reducing costs by 30-70%.
- No immediate generic competition expected before 2027, maintaining high prices until then.
- Potential for price reductions driven by healthcare system negotiations, especially if biosimilars or alternative therapies gain approval.
Market Entry of Generics:
- Once patents expire, generic niraparib could enter the market within 1–2 years.
- Early estimates suggest a 50% price reduction upon generic introduction.
- Market volume growth could accelerate with price drops, potentially increasing overall revenue despite reduced per-unit price.
Key Factors Influencing Future Pricing
-
Patent Litigation and Extensions:
Possible patent challenges could delay generic entry or lead to patent extensions based on supplementary patents or formulations. -
Regulatory Approvals:
New indications may expand market size, supporting sustained pricing but also increasing competition. -
Manufacturing Costs and Market Demand:
Stable manufacturing costs are likely, but demand growth driven by expanded indications will influence revenue. -
Healthcare Policies and Reimbursement:
Price negotiations in national healthcare systems (e.g., NICE in the UK, IQWiG in Germany) could exert downward pressure.
Summary Table: Price Projections 2023–2030
| Year | U.S. Monthly Price | Expected European Price | Post-Patent Generic Price | Notes |
|---|---|---|---|---|
| 2023 | USD 12,000–15,000 | USD 10,000–14,000 | USD 6,000–8,000 | Current market; patent protection active |
| 2025 | USD 11,000–14,000 | USD 9,000–13,000 | USD 4,500–6,000 | Approaching patent expiration |
| 2026 | USD 10,000–13,000 | USD 8,500–12,000 | USD 3,500–5,000 | Patent expiry imminent |
| 2027 | USD 9,000–12,000 | USD 7,000–10,000 | USD 2,500–3,500 | Generic market entry anticipated |
| 2028+ | USD 8,000–10,000 | USD 6,500–9,000 | USD 2,000–3,000 | Price stabilization; volume growth potential |
Key Takeaways
- GSK’s Niraparib maintains high pricing until patent expiry around 2027.
- The current market size exceeds USD 600 million annually in the U.S., with growth driven by expanding indications.
- Competition from Olaparib and Rucaparib constrains pricing but is mitigated by distinct clinical profiles and approved indications.
- Generic entry post-2027 will likely reduce prices significantly, impacting revenue streams.
- International disparities reflect differing healthcare policies, influencing pricing and reimbursement strategies.
FAQs
1. When will generic niraparib likely enter the market?
Patent expiration is expected around 2027. Generics may enter within 1–2 years afterward, depending on patent challenges and regulatory approvals.
2. How do current prices compare across markets?
U.S. prices range from USD 12,000 to USD 15,000 per month, while European prices average USD 10,000 to USD 14,000. Emerging markets show lower prices, typically USD 5,000 to USD 8,000.
3. What factors could affect future pricing?
Patent challenges, regulatory decisions on new indications, biosimilar development, and healthcare reimbursement negotiations.
4. How significant is Niraparib's market share?
It accounts for approximately USD 600–800 million annually in the U.S., behind Olaparib but with growth potential from additional indications.
5. What is the impact of expanded indications on pricing?
Broader approvals can sustain or boost prices temporarily but also increase competition, which may affect long-term pricing strategies.
Sources
- IQVIA. (2022). Pharmaceutical Market Data.[1]
- GSK. (2023). Niraparib prescribing information.[2]
- ICER. (2021). Niraparib Cost-Effectiveness Analysis.[3]
- EMA. (2022). Regulatory status of Niraparib.[4]
- EvaluatePharma. (2022). Market forecasts for ovarian cancer drugs.[5]
[1] IQVIA. (2022). Pharmaceutical Market Data
[2] GSK. (2023). Niraparib prescribing information
[3] ICER. (2021). Niraparib Cost-Effectiveness Analysis
[4] EMA. (2022). Regulatory status of Niraparib
[5] EvaluatePharma. (2022). Market forecasts for ovarian cancer drugs
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