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 three branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma, Cipla, Cipla Ltd, Lupin, Macleods Pharms, Micro Labs, MSN, Sun Pharm, Teva Pharms Usa Inc, and Astrazeneca Ab, and is included in twelve NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for dapagliflozin; metformin hydrochloride

International Patents:	236
US Patents:	6
Tradenames:	3
Applicants:	11
NDAs:	12
Finished Product Suppliers / Packagers:	9
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

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	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No	9,616,028*PED				Y
Teva Pharms Usa Inc	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	211583-004	Apr 6, 2026	AB	RX	No	No
Cipla Ltd	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	211536-001	Apr 6, 2026	AB	RX	No	No
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014	AB	RX	Yes	Yes	8,501,698*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	AB	RX	Yes	No	6,515,117*PED				Y
Sun Pharm	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	211491-002	Apr 6, 2026	AB	RX	No	No
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017	AB	RX	Yes	No

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	205649-001	Oct 29, 2014	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014	6,936,590
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	205649-002	Oct 29, 2014	9,198,925
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	6,936,590
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017	9,198,925
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	9,198,925

International Patents for dapagliflozin; metformin 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
Australia	7848300	C-aryl glucoside sglt2 inhibitors

Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	LUC00152	Luxembourg		PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1506211	13C0022	France		PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
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 [...]
2139494	122020000043	Germany		PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211	588	Finland
1506211	132014902277722	Italy		PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1506211	PA2013008,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112

Last updated: June 23, 2026

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE Market Dynamics and Financial Trajectory (Brand, Generic, and Competitive Set)

Executive summary: Dapagliflozin plus metformin fixed-dose combinations (FDCs) sit at the center of the modern type 2 diabetes market, competing on guideline positioning (SGLT2 inhibitor + metformin first-line use cases), payer coverage for high-efficacy cardiovascular and renal outcomes, and expanding generic pressure on metformin-combination components. Commercial trajectory is driven less by molecule-level patent scarcity than by (1) payer formularies and step-therapy rules, (2) competition from other SGLT2/FDC stacks (empagliflozin, canagliflozin) and GLP-1-based regimens, and (3) ongoing portfolio refresh (dose strengths, country-specific FDC access, and renal indications). Financial performance is also sensitive to post-proprietary entry risk where combination-specific exclusivity narrows, forcing mix shifts to branded strengths, bundles, and differentiated evidence.

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How is the global type 2 diabetes market shifting for dapagliflozin plus metformin FDCs?

What market forces decide uptake in SGLT2 + metformin combinations?

Market adoption in FDCs typically follows four levers:

1. Guideline alignment and physician prescribing habits

   • Treatment intensification from metformin to add-on therapy increasingly includes SGLT2 inhibitors for patients with established atherosclerotic cardiovascular disease, heart failure, and chronic kidney disease, depending on local recommendations and reimbursement rules.
   • FDCs reduce pill burden and can be favored for adherence and simplification in primary care and endocrinology workflows.

2. Payer access, step therapy, and prior authorization

   • Insurers often require documentation of inadequate response to metformin or stepwise progression.
   • Many payers now cover SGLT2 inhibitors earlier, but coverage gaps persist for “non-cardio-renal” indications in certain geographies.

3. Head-to-head efficacy and tolerability signals in real-world practice

   • SGLT2 inhibitors’ benefit-risk profile supports durable use, but discontinuations occur due to genital infections, volume depletion, and renal function monitoring requirements.
   • FDC adoption depends on ability to match patients’ individualized dosing needs (metformin dose titration versus SGLT2 dose selection).

4. Competitive pressure from GLP-1 receptor agonists and triple therapy

   • GLP-1-based combinations can take share where payers prioritize weight loss endpoints, premium formularies prefer incretin agents, and where diabetes burden is strongly linked to obesity management.
   • SGLT2 plus metformin remains a core option because it carries renal and heart failure advantages that GLP-1 agents may not replicate in all populations.

Where does the growth come from vs. churn?

For dapagliflozin plus metformin FDCs, growth typically comes from:

• Expansion of SGLT2 inhibitor use in patients with CKD and heart failure (even in patients without diabetes in some settings, where coverage extends).
• Conversion from metformin monotherapy or separate agents to FDCs for adherence and simplification.

Churn comes from:

• Substitution within the SGLT2 class (especially FDC offerings with equivalent dosing and pricing).
• Switches to GLP-1 regimens where weight loss and glycemic control dominate payer and prescriber decisions.
• Biosimilar and generic pressure affecting brand economics in geographies where combination-level exclusivity is weaker.

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What competitive set most directly pressures dapagliflozin plus metformin FDC sales?

Which branded SGLT2/FDC combinations compete for formulary position?

The closest competition is other fixed-dose or co-administered SGLT2 inhibitor plus metformin stacks, plus alternative add-ons where metformin is already in place.

Key competitive buckets:

• Other SGLT2 + metformin FDCs
  • Empagliflozin + metformin (brand and FDC entries vary by country)
  • Canagliflozin + metformin (availability varies)
  • Other regionally marketed SGLT2/metformin combinations
• SGLT2 + metformin + incremental evidence products
  • Renal and heart failure label expansions can shift preference among SGLT2 leaders based on local label interpretation and payer policies.
• Incretin-based regimens
  • GLP-1 receptor agonists and dual incretin strategies can displace SGLT2 regimens in populations where obesity and appetite control endpoints drive access.

How does competition differ by geography?

• US dynamics: branded coverage for SGLT2 inhibitors is shaped by Medicare Part D formularies, commercial formulary positioning, and formulary rebates. As generics and authorized generics increase, branded volumes can stabilize but revenue declines via price pressure.
• EU dynamics: country-level reimbursement, tendering, and parallel trade influence pricing. FDC market share is sensitive to national uptake patterns for SGLT2 inhibitors and metformin generics.
• Emerging markets: growth depends on healthcare access, distribution, and whether FDC is positioned as a premium adherence product or sold in less integrated form.

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When does dapagliflozin plus metformin lose exclusivity, and what generic entry risks exist?

What drives generic risk for SGLT2 + metformin fixed-dose combinations?

Generic entry risk typically comes in waves:

1. Metformin component genericization
   • Metformin is widely generic. Fixed-dose combination economics depend on the branded SGLT2 layer and any remaining combination exclusivities.
2. SGLT2 molecule and combination-specific exclusivity
   • Exclusive rights expire at different times depending on patent families covering:
     • the active ingredient,
     • polymorphs/solid forms,
     • process claims,
     • specific dosage forms/strengths,
     • and combination formulations or method-of-use.

What generic launch scenarios are most realistic?

For FDC products, the scenarios that most often materialize are:

• Full FDC generic entry: AB-rated generics entering with bioequivalence and matching strength.
• Strength-by-strength entry: partial generic entry where some strengths are market-available earlier than others.
• Switch to separate generics: payer and physician shift to metformin generic plus a generic SGLT2 where available, eroding FDC value proposition.

How do Paragraph IV and Hatch-Waxman plays usually affect FDC revenue?

When exclusivity narrows, Paragraph IV challenges can accelerate generic approvals and launch dates, causing:

• loss of branded market share,
• price compression across strength portfolios,
• higher promotional spend to defend share,
• increased dependence on patient progression and adherence to protected dosing.

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What does the Orange Book status imply for dapagliflozin plus metformin products?

How to interpret Orange Book listings for an FDC strategy

For drugmakers, Orange Book entries matter because they define:

• whether generics can file with carve-outs or challenge specific listed patents,
• which patents appear to block generic FDC substitution,
• and what patents are likely to be asserted in litigation.

For the specific product combination (dapagliflozin; metformin hydrochloride), Orange Book status typically determines:

• whether challenges target the SGLT2 ingredient patents,
• or instead focus on formulation/dosage and method-of-use claims.

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What patent litigation and settlement patterns influence financial trajectory?

How patent disputes translate into commercial outcomes

FDC financial trajectory correlates with the timing and outcome of:

• injunctions preventing generic launch,
• “authorized generic” introductions under settlement,
• and launch delayed by court rulings.

Settlement structures often determine whether branded revenue:

• declines sharply at launch dates, or
• decays more gradually through partial competition and substitution patterns.

What is the most common financial impact pattern after generic entry?

• Rapid early volume erosion in the affected strength.
• Price stabilization at a lower level rather than a complete collapse, depending on channel rebates and persistence.
• Migration to remaining branded strengths or to alternative brand SKUs if some are less directly exposed.

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What FDA regulatory posture supports longer revenue duration for this combination?

Does label expansion extend commercial runway?

Yes in practice. Dapagliflozin-based therapy often sees label updates that expand renal and cardiovascular protection populations and refine dosing guidance. These label expansions can:

• increase patient pool eligibility,
• support payer coverage arguments,
• reduce switching away from SGLT2 in high-risk populations.

How do safety monitoring requirements affect uptake?

Adoption is moderated by:

• clinician workflows for renal function monitoring,
• patient education needs for genital infection risk,
• guidance on volume status and perioperative use.

This creates an “evidence and management” advantage for established branded regimens, but does not eliminate generic switching once access improves.

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How does dapagliflozin plus metformin’s financial performance compare with alternative diabetes regimens?

SGLT2 vs GLP-1 in revenue exposure terms

• GLP-1/dual incretin dominance: revenue growth often accelerates faster where obesity prevalence and payor incentives exist.
• SGLT2 durability: SGLT2 therapies can maintain steadier demand in cardio-renal populations where outcome-driven prescribing and label support persist.

For dapagliflozin plus metformin FDCs, market share can be “sticky” due to outcome benefits and FDC convenience, but total growth is capped by:

• incretin displacement,
• generic price pressure as metformin and SGLT2 layers commoditize across markets.

FDC economics

FDC revenue is typically more resilient than separate co-prescription if:

• adherence and pill burden matter to patients,
• payer reimbursement favors fixed-dose simplicity,
• branded strengths remain protected or rebate-linked.

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What is the likely trajectory across the product lifecycle (share, price, and margins)?

Lifecycle model for an FDC in a mature therapeutic category

A typical SGLT2 + metformin FDC trajectory looks like:

1. Launch and early scaling

   • Broadening prescriber comfort with safety monitoring.
   • Formulary wins and step-therapy reductions.

2. Expansion phase

   • Increased adoption due to label broadenings for cardio-renal outcomes.
   • Growth in CKD and heart failure populations, where physicians treat beyond glycemic targets.

3. Maturity

   • Brand share holds but pricing depends on rebate dynamics.
   • Metformin generics do not directly erode SGLT2 branded economics, but they weaken FDC incremental value.

4. Post-exclusivity

   • Generic entry compresses price.
   • Branded volumes depend on:
     • remaining exclusivity for certain strengths,
     • authorized generics and rebate structures,
     • and channel contracting.

What signals to track for future revenue direction

• Uptake in CKD/heart failure subpopulations after label updates.
• Formulary placement changes that loosen or tighten SGLT2 access.
• Generic launch dates for any matching strength of dapagliflozin; metformin hydrochloride FDC.
• Evidence-driven switchbacks away from GLP-1 where SGLT2 outcome data align more strongly with payer-covered endpoints.

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Key Takeaways

• Dapagliflozin plus metformin FDC demand is driven by guideline alignment for cardio-renal risk management and prescribing convenience, not by metformin alone.
• Competitive pressure comes from other SGLT2/metformin stacks and increasing GLP-1 displacement where weight-loss and premium formularies dominate.
• Financial trajectory hinges on payer access and rebate dynamics plus the timing of generic entry where combination-specific exclusivity narrows.
• Label expansions for cardio-renal outcomes can extend the commercial runway even as pricing faces generic compression.

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FAQs

1) Which payer policies most affect dapagliflozin plus metformin FDC formulary inclusion?

Step-therapy requirements, prior authorization rules tied to metformin intolerance or inadequate control, and documentation standards for cardio-renal risk drive access and abandonment rates.

2) Does dapagliflozin plus metformin lose revenue faster in some strengths than others?

Yes. Strength-by-strength access rules and partial generic entry can cause disproportionate declines where the most dispensed strength is exposed first.

3) How does CKD and heart failure labeling influence sales durability?

It expands eligible patient pools and strengthens payer and prescriber preference, slowing substitution away from SGLT2 regimens even in the presence of generic price competition.

4) What substitution pattern typically replaces an FDC after generic entry?

Patients often switch to separate generics (metformin generic plus SGLT2 generic) or to an alternative SGLT2/FDC product with stronger formulary positioning.

5) How does competition from GLP-1 receptor agonists change the long-term revenue outlook?

It can cap growth by shifting add-on selection away from SGLT2 in populations prioritized for weight loss, while SGLT2 maintains relative strength in cardio-renal cohorts.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. EMA. (n.d.). European public assessment reports and product information. European Medicines Agency.
3. GlobalData/IMS and industry reports. (n.d.). Diabetes drug market trends and payer dynamics (industry databases).