Dapagliflozin; metformin hydrochloride - Generic Drug Details

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

Dapagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride has two hundred and thirty-six patent family members in forty-six countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dapagliflozin; metformin hydrochloride

International Patents:	236
US Patents:	6
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	127
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin; metformin hydrochloride
DailyMed Link:	dapagliflozin; metformin hydrochloride at DailyMed

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

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

Sponsor	Phase
Sultan Qaboos University	PHASE4
LG Chem	PHASE1
AJU Pharm Co., Ltd.	PHASE1

See all dapagliflozin; metformin hydrochloride clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;500MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dapagliflozin; metformin hydrochloride

Drug Class	Biguanide Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

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

A10BA	Biguanides
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; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	2.5 mg/1000 mg	205649	1	2018-10-29
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg	205649	10	2018-01-08

US Patents and Regulatory Information for dapagliflozin; metformin 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	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	7,919,598*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	6,515,117*PED				Y

Expired US Patents for dapagliflozin; metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014	6,936,590
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014	9,198,925
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014	9,198,925

International Patents for dapagliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	101479287
Canada	2780939	FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS)
Norway	2013007
Eurasian Patent Organization	200900066
Norway	347770
India	3573DE2004

Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CA 2013 00019	Denmark
2498758	PA2020003,C2498758	Lithuania		PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	C 2014 029	Romania		PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1506211	SPC/GB13/021	United Kingdom		PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114

Market Dynamics and Financial Trajectory for Dapagliflozin and Metformin Hydrochloride

Last updated: February 20, 2026

What Are the Key Market Drivers for Dapagliflozin and Metformin Hydrochloride?

Dapagliflozin and metformin hydrochloride are prominent in the treatment of type 2 diabetes mellitus (T2DM). The global diabetes medication market exceeds $50 billion in 2022, driven by rising prevalence of T2DM, aging populations, and increasing healthcare expenditures.

Dapagliflozin

• Market Position: Dapagliflozin, marketed as Farxiga (or Forxiga outside the US), is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved in 2014 for T2DM, heart failure, and chronic kidney disease (CKD).

• Market Size: The global dapagliflozin market reached approximately $5 billion in 2022, with compounded annual growth rate (CAGR) projections of 15% over the next five years (MarketWatch, 2022).

• Growth Drivers:

  • Expansion of indications into heart failure and CKD management.
  • Strong evidence of cardiovascular and renal benefits.
  • Favorable safety profile over traditional therapies.

Metformin Hydrochloride

• Market Position: Metformin remains the first-line therapy, prescribed to over 90% of T2DM patients initially.

• Market Size: Estimated at $9 billion globally in 2022, with an expected CAGR of 3% over the next five years (IQVIA, 2022).

• Growth Drivers:

  • Ubiquity in T2DM treatment.
  • Cost-effectiveness.
  • Availability in various formulations, including extended-release options.

How Do Patent Expirations and Generic Entry Affect Market Dynamics?

Dapagliflozin

• Patent Status: Dapagliflozin's primary patents expired in the US in 2023. Patent protections in Europe end in 2025, opening markets to off-patent competition.

• Impact: Generic versions are expected to reduce pricing by approximately 30-50%, pressuring branded sales but also increasing accessibility.

Metformin Hydrochloride

• Patent Status: Metformin has been off-patent globally since the early 2000s.

• Impact: Generics dominate the market, with limited scope for branded pricing strategies.

What Are the Main Competitive Pressures in This Market?

• Emerging Therapies: SGLT2 inhibitors like empagliflozin and canagliflozin compete with dapagliflozin regarding efficacy and safety profiles.
• Combination Therapies: Fixed-dose combinations (FDCs) of metformin with other antidiabetics are gaining market traction.
• Biosimilars and Generics: The rise of generics for dapagliflozin and a saturated metformin market constrain profit margins.

What Are the Regulatory and Reimbursement Trends?

• Regulatory: Approval of dapagliflozin for new indications, including heart failure and CKD, broadens market scope.
• Reimbursement: Payer policies favor cost-effective therapies; metformin's low cost sustains its market share, while dapagliflozin's newer indications prompt negotiations and formulary placements.

What Is the Financial Outlook for Dapagliflozin and Metformin?

Dapagliflozin

Metric	2022 Data	Future Projections
Market Value	~$5 billion	CAGR 15%, reaching ~$10 billion in 2027
Sales Decline Post-Patent	Expected reduction of 30-50% in US market	Due to generic competition, offset by new indications
R&D Investment	Estimated $200 million annually	Focused on expanding indications and formulations

Metformin Hydrochloride

Metric	2022 Data	Future Projections
Market Value	~$9 billion	Growth rate ~3% annually with stable demand
Price Sensitivity	High due to generics	Limited variation, margins decline
R&D Investment	Negligible compared to new drugs	Minimal, focus on formulation optimization

How Do Market Entry Barriers and Patent Strategies Influence Future Revenue?

• Dapagliflozin: Patent expirations will weaken market exclusivity, requiring strategic focus on differentiation and indication expansion.
• Metformin: Off-patent status means no barriers to generic entry, hindering branded revenue potential.

What Are the Key Risks and Opportunities?

Risks

• Pricing pressure from generics and biosimilars.
• Competition from newer antidiabetics with superior efficacy.
• Potential safety concerns or adverse regulatory actions.

Opportunities

• Expansion into cardio-renal indications.

• Demand for combination therapies improves market share.

• Developing delivery formulations such as extended-release tablets.

Summary of Market Dynamics

Factor	Impact
Patent expiration	Declines in revenue for dapagliflozin branded sales; opportunities for generics.
New indications	Broaden dapagliflozin's market, especially for heart failure and CKD.
Competitive landscape	SGLT2 inhibitors face competition; metformin remains dominant in affordability.
Regulatory environment	Approvals for new indications boost dapagliflozin's market size.

Key Takeaways

• Dapagliflozin's rapid growth is driven by its expanding indication portfolio and proven cardiovascular benefits but faces revenue erosion upon patent expiry.
• Metformin's entrenched position offers stable but modest growth; generic competition keeps margins low.
• Strategic focus for manufacturers includes indication expansion, combination regimens, and formulation innovations.
• The presence of biosimilars and generics exerts downward pressure on prices, impacting overall revenue trajectories.
• Regulatory and payer policies will significantly influence strategic planning and market penetration.

FAQs

What factors are driving the growth of dapagliflozin?

The expansion of indications into heart failure and CKD, strong clinical evidence for cardiovascular benefits, and regulatory approvals are key drivers.

How will patent expirations affect dapagliflozin’s market share?

Generic entry post-patent expiry will reduce prices, erode branded revenues, and increase competition but also broaden access through lower-cost options.

Why does metformin maintain its market dominance?

Its low cost, widespread acceptance, and established safety profile keep demand high despite the availability of newer therapies.

Are biosimilars impacting dapagliflozin’s market?

While biosimilars are less relevant due to dapagliflozin’s small-molecule structure, generic versions significantly influence pricing and sales.

What strategies could extend dapagliflozin’s market viability?

Developing new formulations, broadening clinical indications, and forming fixed-dose combination therapies are key.

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References

[1] MarketWatch. (2022). Global SGLT2 Inhibitors Market Size, Share & Trends Analysis Report.

[2] IQVIA. (2022). Global Diabetes Treatment Market Analysis.

[3] European Medicines Agency. (2023). Dapagliflozin (Farxiga): Summary of Product Characteristics.

[4] U.S. Food and Drug Administration. (2014). Approval Letter for Dapagliflozin.