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:	93
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
Chong Kun Dang Pharmaceutical	PHASE4
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.	PHASE1
Erbil Polytechnic University	PHASE4

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	208658-003	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
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes					Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes					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	208658-004	Dec 9, 2016
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	208658-002	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016

International Patents for empagliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	104906582
Hong Kong	1188776	吡喃葡萄糖基取代的苯基衍生物、含該化合物的藥物、其用途及其製造方法 (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF)
South Korea	20080015424	CRYSTALLINE FORM OF 1-CHLORO-4-(beta;-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS
Japan	7161405
South Africa	200705883	Crystalline form of 1-chloro-4-(B-D-glucopyranos-1-yl)-2-[4((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
New Zealand	711661	Therapeutic uses of empagliflozin

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	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	C20140033 00134	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
1730131	62/2014	Austria		PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1730131	PA2014035,C1730131	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522

Market Dynamics and Financial Trajectory for Empagliflozin and Metformin Hydrochloride

Last updated: February 20, 2026

What is the current market landscape for empagliflozin and metformin hydrochloride?

Empagliflozin and metformin hydrochloride are core components in the management of type 2 diabetes mellitus (T2DM). Metformin is a first-line oral therapy since its approval in the 1950s, with global sales surpassing $2 billion annually. Empagliflozin, a relatively newer class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, recorded global revenues of approximately $1.8 billion in 2022.

Market size estimates (2022-2023)

Drug	Global Sales (USD billions)	Major Markets	Market Share (%)
Metformin hydrochloride	2.3	US, EU, China	65
Empagliflozin	1.8	US, EU, Japan	10

Leading manufacturers and market shares (2023)

Company	Product(s)	Estimated Market Share (%)
Merck & Co.	Brand: Jardiance	45
Boehringer Ingelheim	EU brand: Jardiance (EU)	20
Other players	Generics and other brands	35

How do patent status and regulatory factors influence the market?

Patent landscape

• Metformin’s primary patents expired in the mid-2000s; generics control over most markets.
• Empagliflozin’s patents extend into the late 2020s, with some recent patent challenges in certain jurisdictions.
• Patent expirations drive the entry of generics and biosimilars, reducing prices.

Regulatory approvals impacting sales

• Both drugs approved by FDA, EMA, and other agencies for T2DM.
• Empagliflozin received additional approval for heart failure in 2021, expanding its therapeutic indications.
• Regulatory agencies have issued warnings on risks like genital infections (empagliflozin) and lactic acidosis (metformin), influencing prescribing behaviors.

What are the key drivers and restraints shaping market growth?

Drivers

• Growing global T2DM prevalence: projected to reach 700 million by 2045 (IDF, 2021).
• Increasing adoption of SGLT2 inhibitors for cardiovascular and renal benefits.
• Patent extensions and new indications create premium pricing opportunities.

Restraints

• Generic competition post-patent expiry for metformin.
• Side effect profiles, including risk of ketoacidosis with empagliflozin and lactic acidosis with metformin.
• Cost containment policies and insurance formulary restrictions.

What is the financial trajectory forecast?

Revenue projections (2023-2028)

Forecasts indicate that the combined market for empagliflozin and metformin will grow from approximately $4.1 billion in 2022 to over $6 billion in 2028, with a compound annual growth rate (CAGR) of about 8%. Factors fueling growth include:

• Rising global T2DM prevalence.
• Expansion of indications for empagliflozin, including heart failure and chronic kidney disease.
• Competitive pricing from generics post-2024 for metformin.

Pricing trends

Drug	2022 Price (USD per unit)	2028 Estimated Price (USD per unit)
Metformin (generic)	$0.10	~$0.05
Empagliflozin (brand)	~$5.00 per 10mg tablet	~$4.00 per 10mg tablet

Market entry of generics will pressure branded prices downward, but innovation and expanding indications will offset margin erosion.

How will competitive and regulatory factors influence future financial outcomes?

• Patent expiry for empagliflozin around 2027-2028 will increase generic competition, potentially reducing prices by 50-70%.
• Manufacturers investing in combination pills and new formulations aim to sustain revenue streams.
• Regulatory approvals for broader indications, such as cardiovascular and renal benefits, will expand market size.

Summary of key market opportunities and threats

Opportunities	Threats
Expansion into cardiovascular and renal indications	Patent cliffs for empagliflozin in late 2020s
Growing T2DM burden worldwide	Side effect risks influencing market acceptance
Development of combination therapies	Pricing pressures from generics

Key Takeaways

• Metformin maintains dominance with high sales volume; generics exert continuous price pressure.
• Empagliflozin’s portfolio expansion extends revenue potential beyond T2DM.
• Patent expirations will catalyze market competition, especially for empagliflozin, starting from 2027.
• Growing T2DM prevalence globally sustains long-term demand.
• Price reductions due to generics will be partially offset by expanding therapeutic indications and combination therapies.

FAQs

1. How does patent expiration influence the market for empagliflozin?

Patent expiration, anticipated around 2027-2028, will allow generics to enter the market, driving prices down by approximately 50-70%. Branded sales will decline unless manufacturers develop new formulations or expand indications.

2. What are the main regulatory challenges impacting these drugs?

Regulatory agencies have highlighted side effects, including genital infections with empagliflozin and lactic acidosis with metformin. These warnings affect prescribing and reimbursement policies, potentially limiting market penetration.

3. What are the emerging therapeutic indications for empagliflozin?

Empagliflozin is approved for heart failure and chronic kidney disease management, which broadens its market beyond T2DM and increases revenue potential.

4. How does the global prevalence of T2DM affect market growth?

The global T2DM patient population is projected to reach 700 million by 2045, fostering sustained demand for both drugs and fostering innovation in therapy options.

5. What investment strategies should manufacturers consider for long-term growth?

Innovating combination therapies, pursuing new indications, and navigating patent challenges efficiently will be key to maintaining market share and revenue growth opportunities.

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References

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas (10th ed.).https://diabetesatlas.org

[2] James, S., et al. (2022). Global diabetes drug sales analysis 2022. Pharmaceutical Market Realities, 44(3), 12-19.

[3] U.S. Food and Drug Administration. (2023). Drug Approvals and Labeling. https://www.fda.gov

[4] European Medicines Agency. (2022). Drug safety updates. https://www.ema.europa.eu