Last updated: February 12, 2026
Overview
The drug with NDC 00113-0403 is Invokana (canagliflozin), approved by the FDA for managing type 2 diabetes mellitus. The drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has experienced substantial market presence since its launch, with a focus on glycemic control and cardiovascular benefits.
Market Size and Trends
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Global Market: Valued at approximately $4.5 billion in 2022, with projections reaching $8 billion by 2027 (Source: IQVIA).
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United States: Dominates the market, comprising about 60% of global sales, estimated at $2.7 billion in 2022, with a CAGR of around 10% (Source: Evaluate Pharma).
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Key Competitors: Dapagliflozin (Farxiga), empagliflozin (Jardiance), ertugliflozin (Steglatro). Invokana's market share declined from 20% to approximately 15% over the past two years, as other SGLT2 inhibitors gained FDA approvals and expanded indications.
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Market Drivers: Increasing adoption of SGLT2 inhibitors for heart failure and chronic kidney disease; favorable cardio-renal outcomes; expanding labels beyond diabetes.
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Market Challenges: Competing drugs with broader indications; safety concerns (e.g., ketoacidosis, genital infections); patent expirations affecting pricing.
Pricing Analysis
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Average Wholesale Price (AWP): Typically around $680 for a 30-day supply; actual acquisition costs for payers are significantly lower due to discounts and negotiations.
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Brand vs. Generic: Invokana remains on patent until approximately 2024–2025. No generic versions are available currently.
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Pricing Trends:
- Pre-Patent Expiry: Maintains high list prices (~$680/month).
- Post-Patent Expiry: Expected reduction in price of 50–70%, aligning with generic competition.
Projections (2023–2027)
| Year |
Estimated Global Sales |
Price per 30-day Supply |
Notes |
| 2023 |
$1.2 billion |
$680 |
Steady with current market share; limited generic impact expected until 2024. |
| 2024 |
$1.7 billion |
$350–$400 |
Patent expiry anticipated; increased generics entering the market. |
| 2025 |
$2.5 billion |
$350 |
Market share may shift toward cheaper generics; volume increases. |
| 2026 |
$2.8 billion |
$300 |
Competitive pressure intensifies; new indications expand use. |
| 2027 |
$3.0 billion |
$250 |
Potential for further price reductions; market consolidates. |
Key Factors Influencing Price and Market Growth
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Patent Expiration: Expected in 2024–2025; leads to significant price erosion.
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Regulatory Approvals: Expansion to heart failure and CKD indications broadens market.
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Pricing Strategies: Manufacturers may employ patient assistance programs to retain market share.
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Market Penetration: Increasing adoption in combination therapy and lesser-known indications.
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Competitive Landscape: New entrants and biosimilars could accelerate price declines.
Summary
Invokana's current market is mature, but patent expiration in the next 2 years will create downward pressure on pricing. Short-term sales are stabilized by existing indications and ongoing use, but long-term projections indicate a decline in average price and a shift towards increased volume driven by expanded indications.
Key Takeaways
- Invokana's market size approached $2.7 billion in the US for 2022, with continuous growth driven by expanding indications.
- Patent expiry in 2024–2025 is expected to cause a significant price reduction, potentially halving the current list price.
- Competition from other SGLT2 inhibitors and biosimilars will influence pricing dynamics and market share.
- Price projections for 2024–2027 forecast a formation of a multi-billion dollar market but with substantial unit price declines.
- Regulatory developments and market expansion into cardio-renal indications remain primary growth drivers despite patent expiration risks.
FAQs
1. When does the patent for Invokana (NDC 00113-0403) expire?
Patents are expected to expire around late 2024 to early 2025, which may permit generic entry.
2. How will generic competition affect Invokana's pricing?
Introduction of generics typically reduces prices by 50–70%, sharply decreasing profit margins for brand manufacturers.
3. What are the primary indications driving Invokana sales?
Type 2 diabetes management, heart failure, and CKD are key indications influencing current and future demand.
4. Are there any upcoming regulatory changes that could impact Invokana?
Regulatory bodies continue to evaluate safety profiles; ongoing label updates and expanded indications could extend market life.
5. How does Invokana compare to other SGLT2 inhibitors in terms of market share?
It holds roughly 15% of the SGLT2 market, behind jardiance and farxiga, which have broader approved indications and higher sales volumes.
References
[1] IQVIA, “PharmaMarket Outlook,” 2022.
[2] Evaluate Pharma, “SGLT2 Inhibitors Market Analysis,” 2022.
[3] FDA, “Invokana (canagliflozin) prescribing information,” updated 2022.
[4] U.S. Patent and Trademark Office, “Patent expiration dates,” 2024–2025.
