Dapagliflozin; saxagliptin hydrochloride - Generic Drug Details

What are the generic sources for dapagliflozin; saxagliptin hydrochloride and what is the scope of patent protection?

Dapagliflozin; saxagliptin hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; saxagliptin hydrochloride has three hundred and thirteen patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for dapagliflozin; saxagliptin hydrochloride

International Patents:	313
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	27
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin; saxagliptin hydrochloride
DailyMed Link:	dapagliflozin; saxagliptin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin; saxagliptin hydrochloride

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for dapagliflozin; saxagliptin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	PHASE2
UnitedHealthcare	PHASE2
University of Erlangen-Nürnberg Medical School	Phase 4

See all dapagliflozin; saxagliptin hydrochloride clinical trials

Pharmacology for dapagliflozin; saxagliptin hydrochloride

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; saxagliptin hydrochloride

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QTERN	Tablets	dapagliflozin; saxagliptin hydrochloride	5 mg/5 mg	209091	1	2020-07-29
QTERN	Tablets	dapagliflozin; saxagliptin hydrochloride	10 mg/5 mg	209091	5	2018-01-08

US Patents and Regulatory Information for dapagliflozin; saxagliptin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y

Expired US Patents for dapagliflozin; saxagliptin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017

International Patents for dapagliflozin; saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	020428
Poland	210304
Chile	2008000823
Spain	2659862
Mexico	PA04011371	C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO. (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD.)
Canada	2985797

Supplementary Protection Certificates for dapagliflozin; saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	122020000043	Germany		PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211	588	Finland
1506211	C 2013 012	Romania		PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...]
1506211	DO 136; 5005-2013	Slovakia		PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL
1506211	SPC/GB14/050	United Kingdom		PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
2139494	2090034-6	Sweden		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 20160719

Market Dynamics and Financial Trajectory for Dapagliflozin and Saxagliptin Hydrochloride

Last updated: July 30, 2025

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Introduction

The global pharmaceutical landscape for diabetes management has evolved significantly over recent years, driven by innovations in molecular therapies such as dapagliflozin and saxagliptin hydrochloride. These novel agents offer targeted avenues for treating type 2 diabetes mellitus (T2DM), a condition with rising prevalence worldwide. This analysis evaluates the market dynamics and financial trajectory of dapagliflozin and saxagliptin hydrochloride, focusing on their demand drivers, competitive positioning, regulatory environment, and revenue outlook.

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Market Overview: Dapagliflozin and Saxagliptin Hydrochloride

Dapagliflozin, marketed under the brand name Farxiga among others, belongs to the class of SGLT2 inhibitors. It acts by promoting renal glucose excretion, thus lowering plasma glucose levels. Saxagliptin hydrochloride, marketed as Onglyza, is a DPP-4 inhibitor that enhances incretin activity, leading to improved insulin secretion.

Both drugs occupy critical niches within the antidiabetic therapeutic landscape, often prescribed in combination or as monotherapies when initial treatments are insufficient.

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Market Dynamics

Growth Drivers

• Proliferating T2DM Prevalence: The global diabetes epidemic fuels demand. According to the International Diabetes Federation, approximately 537 million adults lived with diabetes in 2021, projected to reach 643 million by 2030. This accelerates the adoption of novel therapies like dapagliflozin and saxagliptin.

• Clinical Efficacy and Safety: Both agents demonstrate favorable efficacy with safety profiles that meet regulatory standards, fostering prescriber confidence and expanding market penetration.

• Expanding Indications and Combination Therapies: Regulatory approvals for combination regimens—e.g., dapagliflozin with metformin—enhance clinical versatility and patient adherence, further boosting sales.

• Chronic Disease Management Focus: The shift toward personalized, long-term disease management sustains demand, especially with ongoing evidence supporting cardiovascular and renal benefits associated with dapagliflozin.

Competitive Landscape

• Market Presence of MNCs: Major players like AstraZeneca, Boehringer Ingelheim, and Bristol-Myers Squibb sell dapagliflozin and saxagliptin. Their established distribution channels and marketing resources confer significant competitive advantages.

• Emerging Generics and Biosimilars: Patent expirations threaten profitability margins. For instance, the expiration of dapagliflozin's patent is anticipated post-2025, inviting generic competition that could substantially erode revenues.

• Pipeline and Formulation Innovations: New fixed-dose combinations (FDCs), once approved, promise to improve adherence and capture greater market share.

Regulatory Environment

• Approval and Reimbursement Policies: Stringent, region-specific approval processes impact drug accessibility. Reimbursement policies favoring these agents, especially due to evidence of cardiovascular benefits, enhance sales prospects.

• Labeling and Indications Expansion: Ongoing clinical trials investigating benefits in cardiovascular and renal protection broaden potential use cases, likely augmenting market size.

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Financial Trajectory

Revenue Trends

• Current Market Size: As of 2022, the global market for SGLT2 inhibitors and DPP-4 inhibitors was valued at approximately USD 5.8 billion, with dapagliflozin and saxagliptin accounting for a significant proportion [1].

• Growth Forecasts: Analyst estimates project a compound annual growth rate (CAGR) of roughly 8-10% for these drugs through 2028 [2]. The expansion is driven predominantly by approved additional indications and increased adoption rates.

Revenue by Region

• North America: Dominates the market with over 45%, driven by high diabetes prevalence, aggressive marketing, and supportive reimbursement policies.

• Europe and Asia-Pacific: Growth is accelerating due to increasing healthcare access, local manufacturing, and regional regulatory approvals.

Profitability and Cost Dynamics

• Pricing Strategies: Premium pricing persists in developed markets; however, impending patent cliffs may force price reductions and shift toward generics.

• R&D and Regulatory Investment: Substantial investments are necessary for ongoing clinical trials, regulatory compliance, and post-market surveillance to sustain revenue streams.

Impact of Patent Expiry and Generics

• Patent expirations, projected around 2025 for dapagliflozin, will introduce generics that could cut revenues by up to 70%, compelling firms to diversify portfolios and innovate further. Firms with early biosimilar strategies are better positioned to mitigate revenue declines.

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Future Outlook

The financial trajectory points toward stabilized growth driven by expanding indications, combination therapies, and the development of next-generation agents. The integration of cardiovascular and renal benefits into clinical practice guidelines, along with growing acceptance in primary care, will underpin sustained revenue streams.

Furthermore, regional expansion into emerging markets, where diabetes burden is rising rapidly, offers lucrative opportunities but necessitates navigating variable regulatory landscapes.

Innovation pipeline progress—such as novel SGLT2 inhibitor formulations, dual-inhibition drugs, and personalized therapies—will influence future revenue dynamics significantly.

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Conclusion

Dapagliflozin and saxagliptin hydrochloride occupy pivotal roles in T2DM management, with their market dynamics shaped by rising disease prevalence, clinical efficacy, competitive pressures, and regulatory considerations. Financial modeling indicates robust growth prospects in the near to mid-term, tempered by imminent patent expirations and increasing generic competition. Strategic positioning through pipeline development, geographic expansion, and leveraging clinical benefits will be critical in sustaining their financial trajectory.

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Key Takeaways

• The global demand for T2DM medications sustains strong growth prospects for dapagliflozin and saxagliptin, projected to grow at an 8-10% CAGR through 2028.
• Patent expirations around 2025 threaten revenue streams, prompting shifts toward biosimilars and innovative formulations.
• Regional market potential varies, with North America leading but Asia-Pacific offering high growth opportunities.
• Clinical updates expanding indications to cardiovascular and renal protection will enhance the market outlook.
• Companies must invest in pipeline innovation and strategic global expansion to offset future revenue declines.

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FAQs

1. When are dapagliflozin and saxagliptin hydrochloride patent protections expected to expire?
Patent protections for dapagliflozin are projected to expire around 2025, opening the market to generics. Saxagliptin's patent expiration date is similar, although regional differences may apply.

2. What are the primary drivers of growth in the SGLT2 and DPP-4 inhibitor markets?
Key drivers include rising global diabetes prevalence, expanding indications to cardiovascular and renal health, favorable efficacy and safety profiles, and development of combination therapies.

3. How does competition from generics impact the future profitability of dapagliflozin and saxagliptin?
Generic entry post-patent expiry is likely to significantly erode revenue margins, pressuring brand-name pricing and market share, unless companies innovate or diversify their portfolios.

4. What regional markets offer growth potential for these drugs?
While North America remains dominant, the Asia-Pacific region presents high growth potential due to increasing diabetes rates and expanding healthcare access.

5. How are regulatory policies influencing the market for these medications?
Supportive policies for cardiovascular and renal indications, along with favorable reimbursement schemes, bolster market expansion, though regulatory stringency in some regions may pose hurdles.

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References

[1] GlobalData, "Diabetes Drugs Market Report," 2022.
[2] MarketsandMarkets, "Diabetes Care Market Forecast," 2023.