DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - Generic Drug Details

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

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

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

Summary for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

International Patents:	292
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
DailyMed Link:	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

9,616,028*PED

Dosage:

TABLET, EXTENDED RELEASE;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; METFORMIN HYDROCHLORIDE; 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
Sabyasachi Sen	Phase 4

See all DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

US Patents and Regulatory Information for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; 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	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y

Expired US Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	9,198,925
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	8,628,799
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019	8,628,799
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	9,198,925
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	6,414,126
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019	9,198,925

International Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Argentina	026024	COMPUESTOS INHIBIDORES SGLT2 DE GLUCOSIDOS DE C-ARILO Y METODO, LAS COMPOSICIONES FARAMCEUTICAS QUE LOS CONTIENEN Y LOS INTERMEDIARIOS DE SINTESIS DEDICHOS COMPUESTOS
Argentina	040032	C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO
Austria	295848
Austria	353334
Australia	2003237886	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD
Australia	781009

Supplementary Protection Certificates for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CA 2013 00019	Denmark
1506211	1390017-0	Sweden		PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1506211	2014C/041	Belgium		PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121
1506211	DO 136; 5005-2013	Slovakia		PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121

Market Dynamics and Financial Trajectory for Dapagliflozin, Metformin Hydrochloride, and Saxagliptin Hydrochloride

Last updated: February 15, 2026

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What is the current market landscape for dapagliflozin, metformin hydrochloride, and saxagliptin hydrochloride?

The market for these antidiabetic drugs is driven by the rising prevalence of type 2 diabetes globally. The combined price for these medications is affected by patent statuses, generic competition, and regional regulatory environments.

• The global diabetes care market reached approximately $85 billion in 2022, with a compound annual growth rate (CAGR) of about 7% from 2021 to 2028.[1]
• Dapagliflozin, marketed as Farxiga by AstraZeneca, accounted for roughly $4 billion in global revenue in 2022, with steady growth driven by its expanding indications and label expansion.
• Metformin hydrochloride remains the most prescribed antidiabetic agent, with a worldwide sales estimate of $6.5 billion in 2022. It benefits from patent expiry, allowing generics to capture significant market share.
• Saxagliptin hydrochloride, marketed as Onglyza by Bristol-Myers Squibb, posted $0.9 billion in sales in 2022, but faces market pressure from newer drugs with superior efficacy profiles.

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What are the key drivers shaping the market for these drugs?

Prevalence of Diabetes: As the number of adults with diabetes nears 537 million globally in 2022, demand for effective management options remains robust.[2]

Regulatory Developments: Regulatory approvals for new indications expand market access. Recent approvals include dapagliflozin for heart failure and chronic kidney disease, which broaden its therapeutic scope.

Generic Competition: Metformin's patent expiry in many regions in the late 2000s led to a wave of low-cost generics. Similar expiries are approaching for dapagliflozin in certain markets, potentially reducing pricing power. Saxagliptin faces generic competition since patent expiration in 2022.

Pricing Trends: Price erosion is anticipated as generics penetrate markets post-patent expiry. In the U.S., the average wholesale price (AWP) for branded dapagliflozin was approximately $530 per month in 2022.[3]

Emerging Therapies: SGLT2 inhibitors like dapagliflozin increasingly used off-label for heart failure and kidney disease management, fostering growth. Conversely, DPP-4 inhibitors like saxagliptin face competition from GLP-1 receptor agonists.

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What is the financial outlook for these drugs over the next five years?

Drug	2023 Revenue Estimate	2028 Projected Revenue	Key Factors
Dapagliflozin	$4.2 billion	$6.1 billion	Label expansions, off-label use, new markets
Metformin Hydrochloride	$6.2 billion	$4.8 billion	Patent expiries, market saturation, price competition
Saxagliptin Hydrochloride	$0.9 billion	$0.7 billion	Market share decline, competition from newer agents

Dapagliflozin: Expected growth driven by expanded indications, especially in heart failure and renal disease. Generic entry could compress margins post-patent expiry.

Metformin: Sales likely to decline due to generics and saturated markets but remains a cornerstone due to affordability and efficacy.

Saxagliptin: Sales to decline with growing preference for insulin and GLP-1 therapies, along with patent expiry.

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What regulatory and policy factors could impact market dynamics?

• Patent Expiries: Dapagliflozin's primary patents in major markets are slated to expire between 2025 and 2027. Post-expiry, generics could reduce prices by 50-80%[4].
• Pricing Regulations: Countries like the U.S. and the UK impose price controls and senior discounts affecting revenue.
• reimbursement policies favor drugs with demonstrated comparative benefits, influencing market share.

How do competitive strategies impact pharmaceutical companies’ financials?

• Expansion of indications allows for higher revenue streams.
• Strategic alliances with biosimilar and generic producers may mitigate revenue losses post-patent expiry.
• Investment in new formulations, fixed-dose combinations, and delivery mechanisms enhances market positioning.

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Final considerations: What are potential risks and opportunities?

Risks:

• Patent cliffs lead to significant revenue declines.
• Competition from newer agents with better efficacy and safety profiles.
• Regulatory delays or rejections affecting market expansion.

Opportunities:

• Label expansions for dapagliflozin into heart failure and chronic kidney disease.
• Entry into emerging markets with high diabetes prevalence.
• Development of combination therapies to improve adherence and efficacy.

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Key Takeaways

• The diabetes drug market is expanding but faces increasing generic competition.
• Dapagliflozin is growing due to new indications, yet patent expiries threaten long-term revenue.
• Metformin remains dominant for affordability, but its growth is plateauing.
• Saxagliptin sales are declining amid better alternatives and patent losses.
• Companies that innovate or secure expanded indications could sustain revenue growth.

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FAQs

1. When will dapagliflozin face significant generic competition?
   Expected patent expiries in major markets between 2025 and 2027[4].

2. Can metformin's market share increase despite generics?
   No; its market share is likely to decline as generics dominate due to lower prices.

3. What new indications are expected to influence dapagliflozin’s sales?
   Heart failure and chronic kidney disease approvals increasingly influence revenue.[1]

4. How does pricing regulation affect these drugs?
   Price controls and reimbursement policies in different regions limit revenue growth and margins.

5. What is the outlook for Saxagliptin in the next five years?
   Declining sales due to market preference for other drug classes and patent expiration.

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Sources

[1] MarketsandMarkets. "Diabetes Care Market by Product." 2022.
[2] International Diabetes Federation. "IDF Diabetes Atlas," 2022.
[3] IQVIA. "Pharmaceutical Market Data," 2022.
[4] U.S. Patent and Trademark Office. "Patent Expiry Timeline," 2023.