Last updated: March 1, 2026
What is NDC 00574-2042?
NDC 00574-2042 corresponds to Invokana (canagliflozin), an SGLT2 inhibitor approved by the FDA in 2013 for type 2 diabetes mellitus. It is part of the SGLT2 inhibitor class that promotes urinary glucose excretion. The drug has a primary indication for glycemic control and has additional benefits in reducing cardiovascular and renal risks.
Market Overview
The global diabetes drugs market, estimated at USD 79 billion in 2021, projects a compound annual growth rate (CAGR) of 7.4% through 2028. SGLT2 inhibitors, including Invokana, captured 17% of the market in 2021 due to increased adoption for both glycemic and cardiovascular indications.
Key Market Drivers
- Expanding indications: Approval of SGLT2 inhibitors for heart failure and chronic kidney disease (CKD).
- Growing prevalence: An estimated 537 million adults with diabetes globally, expected to rise to 643 million by 2030.
- Guideline updates: Diabetes management guidelines increasingly favor SGLT2 inhibitors for patients with comorbid cardiovascular or renal disease.
- Competitive landscape: Several entrants (e.g., Jardiance, Farxiga) challenge Invokana's market share.
Competitive Position
- Market share (2022): Jardiance (empagliflozin): 33%, Farxiga (dapagliflozin): 22%, Invokana: 15%. The remaining share involves other SGLT2 inhibitors and generics.
- Pricing strategies: Branded drugs like Invokana maintain higher prices despite increasing competition; generics are not available yet.
Price Analysis
Historical Pricing
- Average wholesale price (AWP): In 2022, the listed AWP for Invokana 100 mg was approximately $750 for a 30-day supply.
- Insurer discounts: Actual net prices are often 20-30% less than AWP due to pharmacy benefit manager (PBM) negotiations.
- Patient out-of-pocket costs: Vary widely; with insurance, copays range from $10 to $50 monthly, depending on tier.
Price Trends
- Over the past five years, Invokana’s prices remained stable, with slight reductions linked to increased competition and generic threats for other indications.
- The entry of biosimilars or generics could reduce prices by 30-50%, but none currently approved.
Future Price Projections
| Year |
Predicted Wholesale Price (per 30-day supply) |
Key Assumptions |
| 2023 |
$720 – $750 |
No major patent challenges, stable competition |
| 2024 |
$680 – $730 |
Potential patent litigation, moderate generic launch risk |
| 2025 |
$600 – $700 |
Entry of biosimilar/generic competitors reduces price by 10-20% annually |
| 2026 |
$550 – $650 |
Significant generic competition could lead to a 30% drop from peak prices |
Prices depend largely on patent status, regulatory changes, and competitive dynamics. The patent for Invokana is set to expire in 2026, which could trigger a price reduction if generics enter the market.
Patent and Regulatory Status
- Patent expiration: 2026 (original patent) with possible extensions.
- Regulatory pathway for generics: Abbreviated New Drug Application (ANDA) filing, with potential for a 6-12 month market entry post-patent expiry.
Regulatory and Market Risks
- Patent litigation: Can delay generic entry.
- Market penetration of competitors: Jardiance and Farxiga continue to secure market share, limiting Invokana’s growth.
- Label expansion: Additional indications could sustain higher prices, especially if approved for chronic kidney disease or heart failure.
Strategic Considerations
- Pricing flexibility: Manufacturers likely to implement tiered pricing and discounts to retain market share.
- Market penetration: Increasing adoption in cardiology and nephrology may stabilize revenues before generics enter.
- Regulatory risks: Delays or label restrictions could impact sales projections.
Key Takeaways
- Invokana (NDC 00574-2042) remains a relevant factor in the diabetes and cardiovascular markets with a current price of USD 720-750 per month.
- Market share is challenged by competitors, but brand loyalty and expanding indications sustain revenue.
- The patent expiry in 2026 will likely lead to a significant price reduction due to generic entry.
- Price projections for 2023-2026 track a gradual decline, influenced heavily by patent status and competitive pressures.
- The evolving regulatory landscape and market expansion into cardio-renal indications will influence both revenue and pricing strategies.
FAQs
1. When will Invokana face generic competition?
Patent expiration is expected in 2026, opening the pathway for generics.
2. How will price reductions impact sales?
Price reductions could reduce annual revenues by up to 30-50%, especially if generics achieve substantial market penetration.
3. Which factors most influence Invokana’s pricing?
Patent status, competition, regulatory approvals for new indications, and payer negotiations.
4. Are biosimilars or bioequivalents expected?
While traditional generics are likely first, biosimilars are less applicable as Invokana is a small molecule. However, bioequivalent generic versions are expected post-patent expiry.
5. What are the key drivers of demand for Invokana?
Expansion into cardio-renal indications, guidelines endorsing SGLT2 inhibitors, and rising diabetes prevalence.
References
- Grand View Research. (2022). Diabetes Drugs Market Size & Trends Analysis. Retrieved from https://www.grandviewresearch.com/industry-analysis/diabetes-drugs-market
- U.S. Food and Drug Administration. (2013). Invokana (canagliflozin) approval. Retrieved from https://www.fda.gov/
- IQVIA. (2022). National Prescription Audit.
- Evaluate Pharma. (2022). Market Intelligence Reports.
- Pharmaceutical Research and Manufacturers of America. (2022). Patent Data and Market Access Reports.
[1] U.S. Food and Drug Administration. (2013). FDA approves Invokana for type 2 diabetes.
Note: Price estimates and projections are subject to market fluctuations, regulatory developments, and patent litigations.
