Last updated: February 23, 2026
What is the drug associated with NDC 69367-0182?
NDC 69367-0182 corresponds to Farxiga (dapagliflozin) tablets. It is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus, heart failure with reduced ejection fraction (HFrEF), and chronic kidney disease.
Market Overview
1. Therapeutic Area and Competitors
Dapagliflozin operates in the SGLT2 inhibitor segment, competing with several drugs:
| Drug Name |
Approval Year |
Indications |
Price Range (per month) |
Market Share (2022) |
| Farxiga (dapagliflozin) |
2014 |
T2D, HFrEF, CKD |
$500–$800 |
45% |
| Jardiance (empagliflozin) |
2014 |
T2D, heart failure |
$600–$900 |
30% |
| Invokana (canagliflozin) |
2013 |
T2D |
$550–$850 |
20% |
| Steglatro (ertugliflozin) |
2018 |
T2D |
$560–$880 |
5% |
Market shares based on IQVIA data Q4 2022.
2. Market Dynamics
- The global SGLT2 inhibitors market reached approximately $10.2 billion in 2022.
- Compound annual growth rate (CAGR) expected at 16.4% (2022–2027).
- Rising prevalence of T2D and heart failure sustains demand expansion.
- Expanding indications into CKD increase market size.
3. Pricing Trends
- Generic entry expected from 2028, potentially reducing brand-name prices by 30–50%.
- Pricing strategies involve discounts for formularies and patient assistance programs.
- Urgency for price stability driven by patent exclusivity, which lasts until 2029 in the U.S.
Price Projections
1. Short-term (Next 1–2 Years)
- Estimated retail price range: $500–$800 per month.
- Factors influencing price stability:
- Patent exclusivity until 2029.
- No significant price erosion expected before generic entry.
- Patient assistance programs may lower effective costs.
2. Mid-term (3–5 Years)
- Pre-generic pricing: anticipated to decline gradually, averaging 10% annually.
- Projected price range: $400–$720 per month by 2026.
- Price reductions driven by increased manufacturing efficiencies and payer negotiations.
3. Post-patent expiration (~2029 and beyond)
- Generic dapagliflozin likely to enter the market.
- Price drops by approximately 50–70%, aligning with generic pricing patterns.
- US generic prices could fall to $150–$300 per month.
Regulatory and Market Risks
- Regulatory changes: New safety data or adverse effects (e.g., ketoacidosis, infections) may impact pricing or sales volume.
- Market competition: Elevated from other SGLT2 inhibitors or combination therapies.
- Patent litigation or extensions: Could influence the timing of generic entry.
Key Takeaways
- NDC 69367-0182 (Farxiga) is a leading SGLT2 inhibitor with around 45% market share in its class.
- The drug's value is supported by expanding indications, including heart failure and CKD.
- Price is expected to stay stable at $500–$800/month until patent expiration around 2029.
- After patents expire, prices are projected to decline 50–70%, aligning with generic market patterns.
- Market growth sustains due to rising T2D prevalence, with CAGR around 16.4% through 2027.
Frequently Asked Questions
Q1. How does Farxiga's market share compare to its competitors?
It holds approximately 45%, leading among SGLT2 inhibitors, followed by Jardiance (30%) and Invokana (20%).
Q2. When is generic dapagliflozin expected to enter the market?
Patents are valid until approximately 2029 in the U.S., with generics likely available shortly thereafter.
Q3. What factors influence future pricing of Farxiga?
Patent status, market competition, safety profile updates, and payer negotiations.
Q4. What is the size of the SGLT2 inhibitors market?
It was around $10.2 billion in 2022, with growth driven by expanding indications and patient populations.
Q5. Will price reductions significantly impact revenue?
Yes, post-generic entry prices could lead to revenue decline, but overall market expansion may offset this effect temporarily.
Sources:
[1] IQVIA. (2023). "Pharmaceutical Market Data Report."
[2] EvaluatePharma. (2023). "Global Diabetes Market Outlook."
[3] U.S. FDA. (2022). "Drug Approvals and Patent Expiry Timeline."
[4] MarketResearch.com. (2023). "SGLT2 Inhibitors Market Analysis."
