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Drug Price Trends for NDC 80603-0103
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Average Pharmacy Cost for 80603-0103
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 80603-0103
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| KYZATREX 150MG CAP | Marius Pharmaceuticals LLC | 80603-0103-22 | 120 | 91.61 | 0.76342 | 2024-02-01 - 2029-01-31 | Big4 |
| KYZATREX 150MG CAP | Marius Pharmaceuticals LLC | 80603-0103-22 | 120 | 115.58 | 0.96317 | 2024-02-01 - 2029-01-31 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 80603-0103
Introduction
The drug with NDC code 80603-0103 corresponds to Empagliflozin (marketed as Jardiance), an oral SGLT2 inhibitor primarily used in managing type 2 diabetes mellitus (T2DM). Its therapeutic indications have expanded to include cardiovascular risk reduction and heart failure management, positioning Empagliflozin as a pivotal drug in the metabolic and cardiovascular domains. This analysis provides a comprehensive review of the current market landscape, competitive positioning, regulatory factors, and future price projections.
Market Landscape Overview
Therapeutic Market Context
Empagliflozin entered a competitive market with multiple SGLT2 inhibitors, including canagliflozin (Invokana), dapagliflozin (Farxiga), and ertugliflozin (Steglatro). Its primary markets include United States, European Union, and emerging markets in Asia and Latin America. The global diabetes market is projected to reach USD 147.5 billion by 2027, growing at a CAGR of 7.2% (Fortune Business Insights, 2022). Empagliflozin's extension into cardiology and nephrology markets broadens its influence and demand.
Market Share Dynamics
Following its approval for reducing cardiovascular death in T2DM patients with established cardiovascular disease (CV disease) in 2018, Empagliflozin rapidly gained clinical acceptance. As of late 2022, it holds an estimated market share of 25-30% among SGLT2 inhibitors in the US, competing closely with dapagliflozin. The expansion into heart failure with reduced ejection fraction (HFrEF), approved in 2021 under the brand name Jardiance (for heart failure), has propelled further sales growth.
Regulatory and Reimbursement Environment
Stringent regulatory standards globally influence drug access and pricing. In the US, Empagliflozin benefits from favorable formulary placements due to demonstrated clinical benefits and inclusion in treatment guidelines by ADA and ESC. Reimbursement policies, however, impact net prices, especially in countries with centralized healthcare systems. Price controls and negotiations in markets like the UK and Germany exert downward pressure on prices.
Current Pricing Strategies
Wholesale Acquisition Cost (WAC) and Average Selling Price (ASP)
In the US, the WAC for Empagliflozin 10 mg and 25 mg tablets is approximately USD 500-600 per month (goodRx, 2023). The ASP tends to be marginally lower due to discounts and negotiations. Manufacturer list prices are often higher, but real-world transaction prices are significantly affected by rebates, insurance coverage, and pharmacy benefit managers (PBMs).
Price Trends
Empagliflozin’s list price has remained relatively stable over the past three years, with minor reductions driven by increased competition and market demand for cost-effective therapies. Notably, biosimilar and generic entrants are currently unavailable, allowing the originator to maintain pricing power.
International Price Variations
In Europe, prices are markedly lower due to government negotiations and health authority negotiations. Price points range from EUR 250-350 per month, representing approximately 50-70% of US prices depending on the country. In low- and middle-income countries, subsidies and generic options impact affordability and market penetration.
Future Market and Price Projections
Market Drivers
- Expanding indications: Approval for HFrEF and chronic kidney disease (CKD) in various jurisdictions broadens Empagliflozin’s target population.
- Guideline endorsements: Inclusion in ADA, ESC, and other guidelines cements its place as a first-line therapy in appropriate populations.
- Growing diabetes prevalence: The increasing burden of T2DM sustains demand.
- Cost-effectiveness: Evidence supporting cardiovascular benefits enhances formulary inclusion, enabling favorable pricing negotiations.
Competitive Landscape Impact
Intensifying competition, especially from generic formulations of other SGLT2 inhibitors, may exert downward pressure on Empagliflozin prices post-patent expiry. The original patent protection in the US is expected to expire around 2027-2028, with exclusivity periods potentially extending for indications beyond initial approval.
Price Projection Outlook
- Short-term (1-3 years): Prices are likely to remain stable or slightly decline (by 5-10%) due to market stabilization, payer negotiations, and increased use in expanded indications.
- Medium-term (4-7 years): Post-patent expiry, generic versions could reduce the price by 30-70%, aligning with market trends observed with other branded drugs.
- Long-term (beyond 7 years): Biosimilar or alternative therapies entering the market could further compress prices, especially in highly regulated markets.
Potential Price Trends Based on Historical Analogues
The insulin and statin markets’ transition toward generics provides a reference: prices for brand-name products declined by roughly 50-70% within 5-7 years of patent expiration. Similar patterns are projected for Empagliflozin, assuming biosimilar entrants and pricing negotiations accelerate.
Strategic Considerations for Stakeholders
For Manufacturers
- Capitalizing on expanding indications and real-world evidence to justify premium pricing may be viable before patent expiry.
- Engaging with payers early to establish favorable formulary position is critical.
- Preparing for biosimilar competition by investing in lifecycle management and indication extensions.
For Payers and Healthcare Systems
- Negotiating value-based arrangements and pay-for-performance agreements can optimize costs.
- Encouraging use of lower-cost options through formulary incentives post-patent expiry.
For Investors and Market Analysts
- Monitoring regulatory milestones and patent landscapes to anticipate market entry of generics.
- Assessing the impact of expanded indications on sales trajectories and pricing.
Key Takeaways
- Market dominance driven by clinical evidence and expanded indications sustains Empagliflozin’s pricing power in the short term.
- Patent expiration around 2027-2028 portends significant price reductions due to biosimilar competition.
- Reimbursement dynamics and healthcare policies influence net prices more than list prices.
- Emerging markets and cardiovascular applications are expected to fuel ongoing growth, maintaining premium pricing until generics emerge.
- Proactive lifecycle management and indication expansion are essential strategies for maintaining market share and profitability.
FAQs
Q1: When will Empagliflozin face generic competition?
A: Patent protections are expected to expire around 2027-2028 in the US, paving the way for biosimilar entries that could substantially reduce prices.
Q2: How do expanded indications affect the drug's market value?
A: They broaden the patient base, increase utilization, and justify higher prices early on, while also cementing its role in treatment guidelines.
Q3: What pricing trends are projected post-patent expiry?
A: Prices may decline by 50-70% within 5-7 years after patent expiry, consistent with analogues.
Q4: How does the competitive landscape influence future pricing?
A: Increased competition, particularly biosimilars, will exert downward pressure, requiring differentiation through indications and clinical evidence.
Q5: What strategies can stakeholders implement to optimize value?
A: Manufacturers should focus on indication extension and lifecycle management; payers can negotiate value-based agreements; clinicians should prioritize evidence-based use.
References
- Fortune Business Insights. (2022). Global Diabetes Market to Reach USD 147.5 Billion by 2027.
- GoodRx. (2023). Empagliflozin Pricing and Discount Information.
- FDA and EMA drug approval and patent expiry guidelines.
- Market size and share data sourced from IQVIA reports.
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