Drugs in ATC Class A10BK

Up to Top Level ATC Classes

Up to A - Alimentary tract and metabolism

Up to A10 - DRUGS USED IN DIABETES

Up to A10B - BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

Drugs in ATC Class: A10BK - Sodium-glucose co-transporter 2 (SGLT2) inhibitors

Tradename	Generic Name
FARXIGA	dapagliflozin
INVOKAMET XR	canagliflozin; metformin hydrochloride
INVOKANA	canagliflozin
QTERN	dapagliflozin; saxagliptin hydrochloride
QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
XIGDUO XR	dapagliflozin; metformin hydrochloride

A10BK Market Analysis and Financial Projection

The SGLT2 inhibitor market (ATC Class A10BK) is undergoing significant transformation, driven by clinical innovation, patent expirations, and evolving reimbursement strategies. Here's an analysis of the market dynamics and intellectual property landscape:

---

Market Growth Projections

• Global Market: Expected to reach $12.41 billion in 2025, growing at an 8.68% CAGR to $18.82 billion by 2030[1]. North America alone is projected to grow from $7.93 billion in 2025 to $16.37 billion by 2034 (8.4% CAGR)[6].
• Growth Drivers: Rising diabetes prevalence (29.1 million U.S. cases in 2023)[8], coupled with expanded indications for heart failure and chronic kidney disease[12].

---

Regional Adoption Patterns

North America

• Dominated by branded agents like Jardiance (empagliflozin) and Farxiga (dapagliflozin), with formulary positioning increasingly tied to cardiovascular outcomes[5][12].

Europe

• Utilization guided by strict cost-effectiveness thresholds (e.g., UK NICE requiring ≥10% QRISK2 score)[1].
• Generic penetration accelerated by volume-based procurement in countries like Germany[7].

Asia-Pacific

• China’s centralized procurement reduced dapagliflozin prices by 87% in 2022[1].
• Southeast Asian markets prioritize BMI-adjusted prescribing due to higher diabetes risk in lower BMI populations[1].

---

Patent Landscape & Genericization

Key Expirations:	Drug	Composition Patent Expiry	Key Secondary Patents
Dapagliflozin	2025 (US6515117)[12]	Formulation: 2028–2039[12]
Empagliflozin	2025[10]	CV indications: 2039[12]
Ertugliflozin	2030 (PF-04971729)[2]	Synergistic combos: 2035[7]

Strategic Responses:

• Patent Thickets: AstraZeneca filed 100+ Farxiga patents (2022 peak) covering dosage regimens (2039 expiry) and CKD applications[12].
• Generics Impact: DPP-IV inhibitors face 60% price erosion within 2 years post-generic entry, a trend expected for SGLT2s by 2026[13].

---

Innovation Trajectory

1. New Formulations: Co-crystallized dapagliflozin with 92% bioavailability improvements entering EU markets[1].
2. Indication Expansion: 37% of recent filings target non-diabetic uses like obesity and NAFLD[12].
3. Combination Therapies: Fixed-dose products with GLP-1 agonists account for 18% of 2023 pipeline candidates[5].

---

Access Challenges

• LMIC Barriers: Originator prices remain 300% above generics in India[7]. Only 11% of LMIC formularies include SGLT2 inhibitors due to cost[7].
• HTA Demands: CADTH now requires QALY gains ≥0.15 for first-line T2D reimbursement – achieved by only empagliflozin and canagliflozin[5].

---

Future Outlook

The 2025–2030 window will see:

• Generic Dominance: 75% U.S. market share loss for originators by 2028[6][13].
• Value-Based Pricing: Outcomes-based contracts covering 43% of EU payers by 2026[1].
• South-South Manufacturing: Indian generics producers targeting $1.2B API exports by 2027[7].

"The SGLT2 market will bifurcate into low-cost generics for glycemic control and premium-priced agents for cardio-renal protection." – Mordor Intelligence[1]

References

1. https://www.mordorintelligence.com/industry-reports/sglt-2-market
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC4635049/
3. https://atcddd.fhi.no/atc_ddd_index/?code=A10BK
4. https://patents.google.com/patent/EP1506211B1/en
5. https://www.cda-amc.ca/sites/default/files/2023-10/TS0002-000%20SGLT2%20Inhibitors%20in%20Type%202%20Diabetes%20streamlined%20class%20review_draft%20report%20v2__Oct%2019%202023_4.pdf
6. https://www.polarismarketresearch.com/industry-analysis/north-america-sglt2-inhibitors-market
7. https://medicinespatentpool.org/uploads/2020/04/Chapter-4-Patented-medicines-that-the-WHO-Expert-Committee-considered-as-having-relevant-clinical-benefits-but-needing-additional-data-Case-study-on-novel-medicines-for-type-2-diabetes.pdf
8. https://www.biospace.com/sglt2-inhibitors-market-rising-prevalence-of-diabetes-across-the-globe-is-expected-to-drive-the-market
9. https://patentbusinesslawyer.com/blockchain-patent-landscape-comprehensive-guide-for-2024-and-2025/
10. https://list.essentialmeds.org/recommendations/1228/print?format=pdf
11. https://ip.com/blog/2025-patent-trends-challenges-and-innovations-shaping-the-future-of-technology/
12. https://www.greyb.com/blog/farxiga-patent-expiration/
13. https://www.iqvia.com/blogs/2020/01/price-growth-forecast-to-slow-as-patent-expiries-impact-the-diabetes-market