Dapagliflozin; saxagliptin hydrochloride - Generic Drug Details

What are the generic sources for dapagliflozin; saxagliptin hydrochloride and what is the scope of freedom to operate?

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

Dapagliflozin; saxagliptin hydrochloride has two hundred and fifty-six patent family members in forty-eight countries.

Summary for dapagliflozin; saxagliptin hydrochloride

International Patents:	256
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	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
UnitedHealthcare	PHASE2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	PHASE2
University of Erlangen-Nürnberg Medical School	Phase 4

See all dapagliflozin; saxagliptin hydrochloride clinical trials

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	209091-002	May 2, 2019		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	209091-001	Feb 27, 2017		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y

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	209091-002	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
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019

International Patents for dapagliflozin; saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Mexico	352480	FORMULACIONES FARMACEUTICAS QUE CONTIENEN HIDRATO DE PROPILENGLICOL DE DAPAGLIFLOZINA. (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE.)
South Korea	20150038555	다파글리플로진 프로필렌 글리콜 수화물을 함유하는 제약 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE)
South Korea	101502292
Cyprus	1126112
China	100534997

Supplementary Protection Certificates for dapagliflozin; saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	C20200028 00358	Estonia		PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1506211	CA 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2139494	LUC00176	Luxembourg		PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
1506211	588	Finland

Market Dynamics and Financial Trajectory for Dapagliflozin and Saxagliptin Hydrochloride

Last updated: February 20, 2026

What are the current market positions of dapagliflozin and saxagliptin hydrochloride?

Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor marketed by AstraZeneca since 2014 under the brand name Farxiga in the U.S. and Forxiga globally. It targets type 2 diabetes mellitus (T2DM) with additional approvals for heart failure and chronic kidney disease. Globally, it achieved $1.9 billion in revenues in 2022, reflecting a compound annual growth rate (CAGR) of approximately 15% over five years.

Saxagliptin hydrochloride is a dipeptidyl peptidase-4 (DPP-4) inhibitor marketed by AstraZeneca under the brand Tradjenta since 2009 in the U.S. It is used exclusively for T2DM management. In 2022, saxagliptin generated roughly $800 million globally, with stable demand despite competitive pressure.

How do patent protections and regulatory approvals influence market trajectories?

Dapagliflozin's U.S. patent expired in 2022, but generic competition has yet to significantly impact pricing and revenues due to ongoing patent litigation and patent term extensions. Regulatory approvals expand the indications, notably for heart failure (approved 2020), which broadens market potential. Europe and other regions have similar patent timelines, influencing regional revenue streams.

Saxagliptin faced patent expirations in developed markets by 2021, yet patent litigation and secondary patents have delayed generic entry in some areas, maintaining its market share. Its label is restricted to monotherapy or combination with metformin or other agents, limiting growth pathways.

What are the key market drivers?

The primary driver is the increasing global prevalence of T2DM, projected to reach 700 million cases by 2045, according to the International Diabetes Federation. The shift toward SGLT2 inhibitors, due to their proven benefits in reducing cardiovascular and renal outcomes, boosts dapagliflozin’s market prospects. The expanding label indications for dapagliflozin, especially in heart failure with reduced ejection fraction (HFrEF), contribute further.

Saxagliptin’s market sustains through its longstanding use, though growth opportunities diminish as more effective and emerging drug classes capture attention.

How does competitive landscape influence the financial outlook?

Dapagliflozin faces competition primarily from other SGLT2 inhibitors like empagliflozin (Jardiance) and canagliflozin (Invokana). These drugs hold larger market share in some regions, with Jardiance reporting $3.3 billion in 2022 revenue. Cost differentials and clinician preference influence market penetration.

Saxagliptin faces substantial competition from other DPP-4 inhibitors such as sitagliptin (Januvia), linagliptin (Tradjenta), and alogliptin. Januvia leads with $6.4 billion worldwide, reducing saxagliptin’s relative market share.

What is the future revenue potential?

Dapagliflozin’s revenue is projected to grow at a CAGR of around 10-12% over the next five years, driven by expanded indications, new formulations, and increasing global adoption. The potential for growth in non-diabetes indications, particularly for cardiorenal therapy, represents a significant upside.

Saxagliptin’s sales are expected to decline gradually due to patent expiry, market saturation, and competition from newer drug classes such as GLP-1 receptor agonists (e.g., semaglutide). However, established use in certain markets sustains some revenue, estimated to decline at a CAGR of -3% over the same period.

What are the regulatory and pricing trends influencing revenues?

Regulatory agencies are emphasizing cardiovascular and renal outcomes data. Dapagliflozin’s approval for multiple indications aligns with this trend, potentially commanding premium pricing in some markets. Price pressures are mounting globally, particularly in countries adopting reference pricing and cost containment strategies.

In contrast, saxagliptin faces price erosion as biosimilars and generics enter the market, with the potential for significant discounts in regions where patent expiry has occurred.

Summary of Financial Trajectory

Drug	2022 Revenue (USD millions)	2023-2027 CAGR	Key Market Drivers	Patent Status	Competitive Landscape
Dapagliflozin	1,900	10-12%	Expanded indications, cardiorenal benefits	Patent expired 2022 (U.S.)	Leading competitor: Jardiance
Saxagliptin	800	-3%	Long-standing use, limited new indications	Patent expired 2021 (most markets)	Primarily behind newer agents

Key Takeaways

• Dapagliflozin remains a high-growth asset, supported by new indications and broadened therapeutic use. Patent competition will pressure prices, but revenue growth persists due to expanding indications and patient population.
• Saxagliptin's market is consolidating, with declining revenues due to patent expiration and competition from newer agents. It maintains niche use where clinicians prefer DPP-4 inhibitors with established safety data.
• Both drugs are impacted by evolving regulatory standards emphasizing cardiovascular outcome benefits, influencing pricing and market access.

FAQs

1. How will patent expiry affect dapagliflozin's revenues?
Patent expiry in 2022 opens the market to generics. While patent litigation and patent term extensions delay price erosion, generics are expected to capture market share gradually, leading to revenue decline unless the brand maintains premium positioning via new indications.

2. Are new indications for dapagliflozin significant for revenue growth?
Yes, approvals for heart failure and chronic kidney disease broaden its use beyond T2DM, increasing patient volume and allowing premium pricing in some markets.

3. What are the primary competitive threats for saxagliptin?
Entry of biosimilars post-patent expiry and the rise of GLP-1 receptor agonists and SGLT2 inhibitors as preferred therapies limit saxagliptin’s market share.

4. How do regulatory trends influence future revenues?
Regulators prioritize drugs demonstrating cardiovascular and renal benefits, favoring dapagliflozin. Price controls, especially in Europe and emerging markets, pressure margins for both drugs.

5. Will the market for these drugs expand or contract in coming years?
Dapagliflozin’s market is expected to grow modestly, driven by expanding indications. Saxagliptin’s market will decline as newer agents displace DPP-4 inhibitors and patent protections fade.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.
[2] AstraZeneca. (2023). Farxiga product information.
[3] IQVIA. (2023). Pharmacy and Hospital Sales Data.
[4] Evaluate Pharma. (2023). Sales Forecasts for Antidiabetic Drugs.
[5] U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Data.