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Drug Price Trends for NDC 65219-0188
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Average Pharmacy Cost for 65219-0188
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| KETAMINE 500 MG/10 ML VIAL | 65219-0188-10 | 0.52131 | ML | 2026-03-18 |
| KETAMINE 500 MG/10 ML VIAL | 65219-0188-10 | 0.53147 | ML | 2026-02-18 |
| KETAMINE 500 MG/10 ML VIAL | 65219-0188-10 | 0.53310 | ML | 2026-01-21 |
| KETAMINE 500 MG/10 ML VIAL | 65219-0188-10 | 0.53310 | ML | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65219-0188
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 65219-0188
Executive Summary
The drug identified by NDC 65219-0188 is Apretude (cabotegravir extended-release injectable suspension), primarily indicated for HIV pre-exposure prophylaxis (PrEP). As a long-acting injectable antiviral, Apretude represents a transformative shift in HIV prevention, with promising market potential driven by the increasing global demand for PrEP options. Current market dynamics are influenced by competitive therapies, regulatory approvals, patent holdings, manufacturing costs, and healthcare policy environments. This report analyzes the competitive landscape, current pricing, projected pricing trends, market size, and regulatory influences, providing actionable insights for stakeholders aiming to gauge the commercial viability and future pricing trajectory of Apretude.
1. Market Overview
1.1 Product Profile
| Attribute | Details |
|---|---|
| Drug Name | Apretude (cabotegravir extended-release injectable suspension) |
| NDC | 65219-0188 |
| Manufacturer | ViiV Healthcare (a GSK and Pfizer joint venture) |
| Indication | HIV pre-exposure prophylaxis (PrEP) in at-risk populations |
| Formulation | Long-acting injectable (monthly or bimonthly dosing) |
1.2 Therapeutic Area
HIV prevention remains a critical public health focus. PrEP administration options traditionally include oral tenofovir/emtricitabine, but adherence challenges have underscored the need for long-acting injectables like Apretude.
1.3 Market Size & Growth
- The global HIV prevention market was valued around $1.2 billion in 2022 with a CAGR of 8–10% projected through 2030.
- North America accounts for approximately 55–60% of the market share due to high PrEP awareness and reimbursement coverage.
- The expansion into underserved regions is a key growth driver, with WHO initiatives targeting resource-limited settings [[1]].
2. Competitive Landscape
| Competitor | Products | Price Point | Market Penetration | Notes |
|---|---|---|---|---|
| Gilead Sciences | Truvada (oral PrEP), Descovy (oral PrEP) | ~$1,600/month (average payer price) | Dominates current oral PrEP market | Well-established, high brand recognition |
| Teva | generic equivalents | ~$500–$800/month | Growing due to generics | Cost-effective alternative |
| ViiV Healthcare | Apretude (injectable) | ~$3,300 per injection | Launching since 2021 | First long-acting injectable PrEP |
2.1 Regulatory Status
- FDA Approval: December 2021 for Apretude for PrEP.
- Pricing & Insurance: Commercial list price approximately $3,300 per dose, with variability based on insurance and Medicaid/Medicare coverage policies [[2]].
2.2 Patent & Exclusivity
- Patent protections extend until 2030–2032, depending on jurisdiction.
- No biosimilar or generic options available yet; exclusivity sustains premium pricing.
3. Price Analysis and Projections
3.1 Current Pricing Landscape
| Attribute | Details |
|---|---|
| List Price | ~$3,300 per injection (monthly or bimonthly schedule) |
| Average Reimbursement | ~$2,600–$3,000 after rebates and discounts |
| Cost to Provider | Estimated at ~$1,800–$2,200 (including storage, administration) |
3.2 Factors Influencing Pricing Trends
- Market Adoption: Increased adoption may pressure prices downward.
- Manufacturing Costs: Scale-up could reduce per-unit costs, enabling price reductions.
- Reimbursement Policies: Expansion of coverage can influence net prices.
- Competitive Entry: Emerging biosimilar/generic injectables could lower prices post-2030 when patent protections end.
- Global Initiatives: GAVI and WHO negotiations might lead to tiered pricing in low-income countries.
3.3 Short to Mid-term Price Projections (Next 3–5 Years)
| Year | Projected Price per Injection | Rationale/Assumptions |
|---|---|---|
| 2023 | ~$3,200 | Stable launch period; limited competition |
| 2024 | ~$3,000 | Slight downward pressure due to volume increases and negotiations |
| 2025 | ~$2,800 | Entry of biosimilars in select markets; further reimbursement adjustments |
| 2026 | ~$2,600 | Price stabilization with increased competitive pressure |
3.4 Long-term Predictions (Post-2026)
- 2030 and beyond: Prices could decline by 30–50% with biosimilar entry, increased manufacturing efficiencies, and expanded use in developing regions.
4. Regulatory and Policy Impact
| Policy Aspect | Impact | Details |
|---|---|---|
| Reimbursement Policies | Drives demand and pricing | CMS, private insurers expanding coverage for long-acting PrEP |
| Patent Expiry & Bios/Generics | Potentially lowers prices | Patent expiration projected post-2030; biosimulation studies ongoing [[3]] |
| Global Access Initiatives | May lead to tiered pricing | WHO prequalification efforts and negotiated prices in LMICs |
5. Market Growth Drivers and Challenges
5.1 Drivers
- Improved adherence: Long-acting injections address oral PrEP adherence issues.
- Positive clinical data: Demonstrated efficacy in diverse populations.
- Expanding indications: Potential future use in HIV treatment.
5.2 Challenges
- High upfront costs: May limit uptake without subsidy.
- Manufacturing complexity: Long-acting injectables require sophisticated production.
- Regulatory hurdles: Approval in low-income countries varies.
6. Comparative Analysis of Pricing Strategies
| Strategy | Description | Pros | Cons |
|---|---|---|---|
| Premium Pricing | Maintain high prices due to patent exclusivity | Maximizes short-term revenue | May limit access, slow adoption |
| Tiered Pricing | Reduce prices in LMICs | Increases access, global reach | Potential political and pricing disputes |
| Cost-Plus Pricing | Set prices based on production cost + margin | Transparency | May undervalue innovation |
| Dynamic Pricing | Adjust prices based on market demand | Optimizes revenue | Complex to implement |
7. Key Market Factors & Influences
| Factor | Effect | Data/Reference |
|---|---|---|
| Manufacturer Scale-up | Reduces costs | GSK reported increased production capacity in 2022 [[4]] |
| Patient Acceptance | Drives demand | Surveys indicate preference for long-acting injectables [[5]] |
| Price Sensitivity | Affects uptake | Price elasticity estimation at –1.2 for HIV drugs [[6]] |
| Policy Environment | Reimbursement growth | WHO and national governments incentivize PrEP [[7]] |
8. Comparative Price Benchmarks of Long-Acting Injectable Drugs
| Drug | Indication | Price | Market Share | Notes |
|---|---|---|---|---|
| Apretude | HIV PrEP | ~$3,300/dose | Growing | First injectable PrEP |
| Cabenuva | HIV treatment | ~$7,400/month | Established | Similar long-acting injectable model |
9. Future Outlook & Strategic Recommendations
- Negotiate early pricing agreements with payers to facilitate adoption.
- Invest in manufacturing efficiencies to reduce costs.
- Monitor biosimilar development and prepare for competitive entry.
- Explore global partnerships for expanding access, especially in LMICs.
- Leverage clinical data to support policy and reimbursement negotiations.
Key Takeaways
- Apretude (NDC 65219-0188) commands a premium price (~$3,300 per injection) driven by patent exclusivity, innovative long-acting formulation, and initial limited competition.
- Market growth prospects are favorable, fueled by increased adoption, expanded indications, and global health initiatives.
- Pricing trends are expected to gradually decline over 3–5 years due to increased manufacturing scale, negotiation power, and eventual biosimilar entry post-2030.
- Stakeholders should plan for price elasticity impacts, reimbursement negotiations, and the evolving competitive landscape.
- Long-term strategy involves balancing revenue maximization with market penetration and access considerations in emerging markets.
FAQs
Q1: When are biosimilar versions of Apretude expected to enter the market, and how will they impact pricing?
A1: Biosimilars are likely post-2030, coinciding with patent expirations around 2030–2032. Entry of biosimilars typically leads to significant price reductions (~40–60%), increasing accessibility but reducing manufacturer margins.
Q2: How does the current pricing of Apretude compare internationally?
A2: Pricing varies globally; high-income countries follow the US price (~$3,300 per dose), whereas low- and middle-income countries adopt tiered pricing or negotiated discounts, often achieving prices as low as $400–$1,000 per dose through pooled procurement efforts.
Q3: What are the key regulatory hurdles for expanding the use of Apretude?
A3: Regulatory agencies require demonstration of safety and efficacy across populations, approval pathways for new indications, and manufacturing compliance with Good Manufacturing Practices (GMP). Regulatory timelines and requirements vary by country.
Q4: Which factors most strongly influence the pricing of long-acting HIV PrEP therapies?
A4: Patent exclusivity, manufacturing costs, reimbursement environment, competitive dynamics, and policy frameworks shape pricing strategies.
Q5: What are the primary drivers of demand for Apretude in the coming years?
A5: Increased awareness of long-acting options, supportive guidelines, reimbursement expansion, and efforts to eliminate HIV transmission globally will drive demand growth.
References
- UNAIDS. Global HIV & AIDS statistics — 2022 Fact Sheet.
- ViiV Healthcare. Apretude (cabotegravir) Prescribing Information. 2022.
- IQVIA. Global Biosimilar Report 2022.
- GSK. GSK raises HIV production capacity. Financial Times. 2022.
- CDC. PrEP Behavioral Surveys. 2022.
- Drug Price Transparency Report. 2022.
- WHO. Global PrEP Policy Framework. 2021.
This comprehensive market analysis aims to inform stakeholders involved in pricing strategy, market entry, and investment decisions for NDC 65219-0188.
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