Empagliflozin; metformin hydrochloride - Generic Drug Details

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

Empagliflozin; metformin hydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Zydus Pharms, and is included in three NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Empagliflozin; metformin hydrochloride has three hundred and ninety-four patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for empagliflozin; metformin hydrochloride

International Patents:	394
US Patents:	15
Tradenames:	3
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	90
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for empagliflozin; metformin hydrochloride
DailyMed Link:	empagliflozin; metformin hydrochloride at DailyMed

Recent Clinical Trials for empagliflozin; metformin hydrochloride

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

Sponsor	Phase
Erbil Polytechnic University	PHASE4
Kurdistan Higher Council of Medical Specialties	PHASE4
Sun Yat-sen University	PHASE3

See all empagliflozin; metformin hydrochloride clinical trials

Pharmacology for empagliflozin; metformin hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for empagliflozin; 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 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYNJARDY	Tablets	empagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg	206111	4	2018-08-01
SYNJARDY XR	Extended-release Tablets	empagliflozin; metformin hydrochloride	5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg	208658	3	2018-08-01

US Patents and Regulatory Information for empagliflozin; metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-002	Aug 26, 2015		RX	Yes	No
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-003	Aug 26, 2015		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No					Y

Expired US Patents for empagliflozin; metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016

International Patents for empagliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	6431959
Argentina	048041	DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, COMPOSICIONES FARMACEUTICAS Y PROCEDIMIENTO PARA SU PREPARACION
Slovenia	1888552
China	109512831
Malaysia	151336	GLUCOPYRANOSYL-SUBSTITUTED PHENYL DERIVATIVES, MEDICAMENTS CONTAINING SUCH COMPOUNDS, THEIR USE AND PROCESS FOR THEIR MANUFACTURE.
Canada	2587639	DERIVES DE BENZENE SUBSTITUES PAR GLUCOPYRANOSYLE, MEDICAMENTS CONTENANT CES COMPOSES, LEUR UTILISATION ET LEUR PROCEDE DE FABRICATION (GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVES, MEDICAMENTS CONTAINING SUCH COMPOUNDS, THEIR USE AND PROCESS FOR THEIR MANUFACTURE)

Supplementary Protection Certificates for empagliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	C01730131/04	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
1730131	2014/055	Ireland		PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	C 2014 039	Romania		PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522
1730131	PA2014035	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	200 5026-2014	Slovakia		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131	C01730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014

Market Dynamics and Financial Trajectory for Empagliflozin and Metformin Hydrochloride

Last updated: October 20, 2025

Introduction

Empagliflozin and Metformin Hydrochloride are pivotal in managing type 2 diabetes mellitus (T2DM), representing a combination of innovative and established therapies. Their combined market presence reflects evolving treatment paradigms, regulatory landscapes, and competitive dynamics. This analysis delineates the market drivers, growth trajectories, and key financial factors influencing these drugs, providing insight into their current status and future potential.

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Pharmacological Profile and Market Position

Empagliflozin, marketed under the brand Jardiance among others, is an SGLT2 inhibitor developed by Boehringer Ingelheim and Eli Lilly. It functions by reducing renal glucose reabsorption, promoting glycosuria, and improving glycemic control. Additionally, clinical trials have demonstrated its cardiovascular benefits, including reductions in mortality among T2DM patients with cardiovascular disease [1].

Metformin Hydrochloride is a biguanide, historically the first-line agent for T2DM management. Its extensive use stems from a well-established efficacy profile, safety, and low cost, making it a cornerstone in diabetes therapy (FDA-approved since the 1990s).

Market Synergy

The combination of Empagliflozin with Metformin is typically prescribed as a fixed-dose formulation or as adjunct therapy, optimizing glycemic control, minimizing pill burden, and improving adherence. This synergy positions both drugs favorably in treatment algorithms, further reinforced by clinical guidelines endorsing combination therapy in persistent hyperglycemia.

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Market Dynamics

1. Growing Global Diabetes Burden

T2DM prevalence surged globally, with estimates projecting over 536 million affected individuals by 2021, and an anticipated increase to 700 million by 2045 [2]. This expanding diabetic population underpins sustained demand for effective therapies, directly influencing Empagliflozin and Metformin markets.

2. Evolving Treatment Guidelines

Guidelines from the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) advocate early combination therapy for high-risk patients, favoring agents like SGLT2 inhibitors for their cardiovascular and renal benefits [3]. The inclusion of Empagliflozin as a preferred agent has catalyzed growth, especially in patients with cardiovascular comorbidities.

3. Regulatory Approvals and Indications

Empagliflozin received additional indications, including heart failure and chronic kidney disease (CKD), broadening its market scope [4]. Such approvals elevate its prominence beyond glycemic control, promoting off-label utilization, and increased prescribing.

In comparison, Metformin’s long-standing safety profile ensures widespread use, though concerns over lactic acidosis (rare) and tolerability issues in certain populations influence prescribing patterns.

4. Market Competition and Patent Landscape

The competitive arena includes other SGLT2 inhibitors (dapagliflozin, canagliflozin) and biguanides. The expiration of many patents for Metformin has led to generic proliferation, drastically reducing prices and increasing accessibility. Conversely, Empagliflozin's patent protection extends until early 2030s, maintaining pricing power for brand-name formulations [5].

5. Pricing and Reimbursement Policies

Reimbursement variations across markets affect adoption rates. High-income regions with advanced healthcare systems see higher uptake of Empagliflozin, supported by favorable insurance coverage. In low- and middle-income countries, Metformin’s affordability sustains its dominance, although brand-name SGLT2 inhibitors are gaining traction as economies evolve.

6. Market Penetration and Patient Adherence

Combination formulations improve adherence, especially in chronic diseases like T2DM. The availability of fixed-dose combinations (FDCs) of Empagliflozin and Metformin further enhances convenience and compliance, boosting market penetration.

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Financial Trajectory

1. Revenue Trends and Market Size

The global diabetes drugs market was valued at approximately $51.4 billion in 2021, with SGLT2 inhibitors accounting for rapid growth segments. Empagliflozin contributed significantly, driven by its multiplatform indications and favorable clinical outcomes, with global sales exceeding $3.5 billion annually in recent years [6].

Metformin remains the highest-selling oral anti-diabetic, with sales exceeding $1.2 billion globally, predominantly in generic forms, though brand-name versions maintain a premium position in certain markets.

2. Growth Projections

Analysts project the SGLT2 inhibitor segment to grow at a compound annual growth rate (CAGR) of 8-10% over the next five years, buoyed by clinical data supporting cardiovascular and renal benefits [7]. Empagliflozin is poised to benefit from this trajectory, with projected revenues surpassing $5 billion by 2025.

Metformin's market stability persists but is expected to decline slightly in value proportionally due to substitutive effects of newer agents. Nevertheless, its volume-based sales remain robust, especially in price-sensitive markets.

3. Impact of Patent Expirations

Generic versions of Metformin’s extended-release formulations have reduced pricing, eroding profit margins for branded versions. Conversely, Empagliflozin’s patent protection sustains pricing power, maintaining premium revenue streams until patent cliffs occur.

4. R&D and Pipeline Developments

Investment in pipeline drugs and biosimilars influences market evolution. For Empagliflozin, ongoing research into cardiovascular and renal indications, as well as combined therapies, could expand revenue streams. For Metformin, biosimilar development aims to increase affordability and access.

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Key Market Drivers & Challenges

Drivers	Challenges
Rising T2DM prevalence globally	Patent expiries for Metformin and emerging generics pressure prices
Expanded indications for Empagliflozin	Market saturation in mature regions
Clinical benefits beyond glucose control	Competing drugs with similar benefits (dapagliflozin, canagliflozin)
Favorable reimbursement policies	Concerns regarding adverse events (e.g., ketoacidosis, genitourinary infections)
Increasing adoption of combination therapies	Cost barriers in low-income markets

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Conclusion

The market for Empagliflozin and Metformin Hydrochloride remains robust, driven by epidemiological trends, evolving clinical guidelines, and expanding indications. Empagliflozin’s positioning as a multi-benefit agent promises continued growth, supported by clinical validation and regulatory endorsements. Meanwhile, Metformin’s entrenched status benefits from cost advantages and global accessibility, though its market share faces pressure from newer therapies.

Manufacturers and investors should monitor patent expiry timelines, regulatory approvals, and shifts in treatment paradigms to capitalize on emerging opportunities. Strategic focus on combination formulations, expanding indications, and tackling affordability will be paramount in shaping future financial trajectories.

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Key Takeaways

• Market Expansion: Rising global diabetes rates sustain demand; Empagliflozin benefits from additional cardiovascular and renal indications.
• Competitive Landscape: Patent protections for Empagliflozin support premium pricing; generics dominate Metformin markets, affecting profit margins.
• Growth Outlook: The SGLT2 inhibitors segment is expected to grow at a CAGR of 8-10%, with Empagliflozin leading in revenue potential.
• Regulatory Influence: Approvals for additional indications broaden markets; reimbursement policies significantly influence market penetration.
• Strategic Focus: Combination therapies and handling patent expirations will be critical for maintaining and enhancing revenue streams.

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FAQs

1. How will patent expirations impact Empagliflozin’s market share?
Patent expiries typically lead to generic competition, significantly reducing prices and margins. These dynamics may drive market saturation, prompting manufacturers to innovate or diversify indications to sustain revenue.

2. What role do combination therapies play in the Empagliflozin and Metformin market?
Fixed-dose combinations enhance patient adherence, streamline therapy, and expand market reach. Their growing acceptance contributes substantially to revenue growth.

3. Are there safety concerns that could affect Empagliflozin’s market growth?
While generally safe, risks like ketoacidosis, urinary infections, and volume depletion are monitored. Accumulating real-world safety data influence prescribing and regulatory decisions.

4. How does the cost of therapy influence adoption in low-income regions?
Price sensitivity limits adoption of branded agents like Empagliflozin; generics of Metformin dominate in these markets, ensuring continued usage but constraining premium pricing opportunities.

5. What future developments could influence the trajectory of these drugs?
Advances in biosimilars, new combination formulations, expanded indications, and comparative effectiveness research will shape future market dynamics.

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References

1. Verma, S. & McMurray, J. J. V. (2020). Empagliflozin in Heart Failure: Impact on Cardiac and Renal Outcomes. The Lancet, 396(10244), 441–442.
2. International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th edition.
3. American Diabetes Association. (2022). Standards of Medical Care in Diabetes—2022. Diabetes Care, 45(Supplement 1).
4. Boehringer Ingelheim. (2021). Jardiance (Empagliflozin) Prescribing Information.
5. IQVIA. (2022). Global Diabetes Market Analysis.
6. EvaluatePharma. (2022). Empagliflozin Sales Data.
7. MarketWatch. (2022). SGLT2 Inhibitors Market Forecast 2022-2027.

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