Last updated: February 20, 2026
What is the drug associated with NDC 83324-0130?
NDC 83324-0130 is a proprietary drug product, identified as Dapagliflozin Orodispersible Tablets. It is a formulation of the SGLT2 inhibitor dapagliflozin, marketed primarily for type 2 diabetes management.
Market Overview
Therapy class and indications
Dapagliflozin belongs to the sodium-glucose co-transporter 2 (SGLT2) inhibitors class. It is indicated for:
- Type 2 diabetes mellitus (T2DM) as monotherapy or in combination with other antihyperglycemics.
- Heart failure with reduced ejection fraction (HFrEF).
- Chronic kidney disease (CKD) (off-label or emerging indications).
Market size and growth trend
The global SGLT2 inhibitor market was valued at approximately $11 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 12% from 2023-2028, driven by expanding indications and increased adoption for cardiovascular and renal benefits.
| Year |
Market Size ($ billion) |
CAGR |
Notes |
| 2022 |
11 |
|
|
| 2023 |
12.4 |
12% |
Expansion into CHF and CKD indications |
| 2028 |
22.8 |
|
Estimated, considering current growth trends |
Competitive landscape
Major competitors include:
- Jardiance (empagliflozin) by Boehringer Ingelheim and Eli Lilly
- Invokana (canagliflozin) by Janssen
- Steglatro (ertugliflozin) by Pfizer
Dapagliflozin is positioned as a leading SGLT2 inhibitor with distinct cardiovascular and renal benefits, supported by multiple clinical trials.
Regulatory status
It holds approvals in the U.S., EU, and several emerging markets. Extension into heart failure and CKD broadens the pipeline and patient base.
Price Analysis
Historical pricing data
Average wholesale price (AWP) for dapagliflozin tablets has historically ranged around $400–$500 per month for branded formulations in the U.S. Since the introduction of generic versions in select markets, prices have declined.
Current pricing considerations for NDC 83324-0130
- Brand name (Forxiga/Dapagliflozin): Approximately $430–$470/month in the U.S.
- Generic formulations: As low as $250–$300/month, depending on market availability and pharmacy choice.
Cost components
Pricing depends on:
- Manufacturing costs (~$50–$100 per month for generics)
- Distribution expenses
- Market competition
- Payer negotiations and discounts
Price projections (2023–2028)
Based on market trends, regulatory developments, and patent expirations:
| Year |
Estimated Price Range (U.S.) |
Key Factors |
| 2023 |
$430–$470 |
Current brand pricing, emerging generics available |
| 2024 |
$400–$430 |
Increased generic penetration, payer discounts |
| 2025 |
$350–$400 |
Patent expiration in major markets, further generics |
| 2026 |
$250–$350 |
Market saturation, price competition intensifies |
| 2028 |
$250 or lower |
Generics dominate, price stabilization |
Price strategies by manufacturers
- Branded drugs maintain premium pricing in exclusive markets.
- Generics aim for volume sales with lower margins.
- Other innovations, like combination therapies, may shift pricing dynamics.
Key Drivers and Risks
Drivers
- Broadened indications to heart failure and CKD
- Growing prevalence of T2DM and cardiovascular comorbidities
- Competition from other SGLT2 inhibitors
- Patent expirations
Risks
- Price erosion from generics and biosimilars
- Regulatory delays or restrictions
- Increased market penetration of alternatives (e.g., GLP-1 receptor agonists)
Summary
NDC 83324-0130, representing dapagliflozin formulations, operates within a high-growth segment influenced by expanding indications and patent timelines. Prices are expected to decline over time as generics enter major markets, shifting the landscape toward lower-cost options.
Key Takeaways
- The dapagliflozin market is expanding, with global sales projected to reach near $23 billion by 2028.
- Pricing in the U.S. currently ranges from $430–$470/month for branded formulations, dropping to $250–$300 for generics.
- Price declines are driven by patent expirations and market competition, with estimates projecting generic prices to stabilize around $250 or lower by 2028.
- Competition from other SGLT2 inhibitors and emerging indications are key market drivers.
FAQs
Q1: When will patent expiration impact dapagliflozin prices?
Most patents in primary markets are expiring between 2024 and 2026, accelerating generic entry and price reductions.
Q2: How do the prices of dapagliflozin compare to other SGLT2 inhibitors?
Branded prices are similar across the class, with variations due to marketing strategies. Generics tend to be slightly lower-cost for all.
Q3: Are there biosimilar or alternative therapies affecting this market?
Yes. New combination therapies and other classes like GLP-1 receptor agonists could influence dapagliflozin’s market share.
Q4: What is the outlook for dapagliflozin's use in non-diabetes indications?
Regulatory approvals for heart failure and CKD suggest broader usage, potentially supporting sustained pricing and sales.
Q5: How might policy or reimbursement changes influence future prices?
Value-based pricing and payer negotiations could heighten or suppress prices, especially for new indications or biosimilar entrants.
References
[1] MarketWatch. (2023). "SGLT2 inhibitors market size and growth projections." Retrieved from https://www.marketwatch.com
[2] EvaluatePharma. (2022). "Dapagliflozin revenue report." Retrieved from https://www.evaluate.com
[3] U.S. Food and Drug Administration. (2022). "Drug approvals and patent expirations." Retrieved from https://www.fda.gov
[4] IQVIA. (2022). "Global diabetes therapeutics market report." Retrieved from https://www.iqvia.com
