EMPAGLIFLOZIN - Generic Drug Details

What are the generic drug sources for empagliflozin and what is the scope of freedom to operate?

Empagliflozin is the generic ingredient in seven branded drugs marketed by Zydus Pharms and Boehringer Ingelheim, and is included in seven NDAs. There are thirty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin has four hundred and eighteen patent family members in forty-six countries.

There are twenty-two drug master file entries for empagliflozin. Four suppliers are listed for this compound. There are eighteen tentative approvals for this compound.

Summary for EMPAGLIFLOZIN

International Patents:	418
US Patents:	30
Tradenames:	7
Applicants:	2
NDAs:	7
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	454
Patent Applications:	3,864
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMPAGLIFLOZIN
What excipients (inactive ingredients) are in EMPAGLIFLOZIN?	EMPAGLIFLOZIN excipients list
DailyMed Link:	EMPAGLIFLOZIN at DailyMed

Recent Clinical Trials for EMPAGLIFLOZIN

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

Sponsor	Phase
Chong Kun Dang Pharmaceutical	PHASE4
Shenyang Northern Hospital	PHASE4
Larry W. Markham	PHASE1

See all EMPAGLIFLOZIN clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
		25MG;5MG	TABLET;ORAL
		25MG	TABLET;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 EMPAGLIFLOZIN

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

Anatomical Therapeutic Chemical (ATC) Classes for EMPAGLIFLOZIN

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JARDIANCE	Tablets	empagliflozin	10 mg and 25 mg	204629	14	2018-08-01

US Patents and Regulatory Information for EMPAGLIFLOZIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	12,115,179*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No	12,263,153
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes	12,263,153

EU/EMA Drug Approvals for EMPAGLIFLOZIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Jardiance	empagliflozin	EMEA/H/C/002677Type 2 diabetes mellitusJardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesFor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney diseaseJardiance is indicated in adults for the treatment of chronic kidney disease.	Authorised	no	no	no	2014-05-22

International Patents for EMPAGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
Japan	2022069476	エンパグリフロジンの治療的使用
South Korea	20240095321
Singapore	151271	GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF

Supplementary Protection Certificates for EMPAGLIFLOZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	LUC00017	Luxembourg		PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2187879	SPC/GB17/031	United Kingdom		PRODUCT NAME: 1-CHLORO-4-(SS-D-GLUCOPYRANOS-1-YL)-2-(4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL)-BENZENE (I.E. EMPAGLIFLOZIN) IN COMBINATION WITH 1-((4 METHYL-QUINAZOLIN-2-YL)METHYL)-3-METHYL-7-(2-BUTYN-1-YL)-8-(3-(R)-AMINO-PIPERIDIN-1-YL)-XANTHINE (I.E. LINAGLIPTIN) OR A P; REGISTERED: UK PLGB 14598/0191 (GB) 20161115; UK EU/1/16/1146/014(NI) 20161115; UK EU/1/16/1146/015(NI) 20161115; UK EU/1/16/1146/016(NI) 20161115; UK EU/1/16/1146/017(NI) 20161115; UK EU/1/16/1146/018(NI) 20161115; UK EU/1/16/1146/007(NI) 20161115; UK EU/1/16/1146/001(NI) 20161115; UK EU/1/16/1146/013(NI) 20161115; UK EU/1/16/1146/002(NI) 20161115; UK EU/1/16/1146/003(NI) 20161115; UK EU/1/16/1146/004(NI) 20161115; UK...

Market Dynamics and Financial Trajectory for EMPAGLIFLOZIN

Last updated: March 4, 2026

What is the Current Market Position of EMPAGLIFLOZIN?

EMPAGLIFLOZIN, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, is prescribed for type 2 diabetes management. Launched by Boehringer Ingelheim in 2014, it was the first SGLT2 inhibitor approved by the FDA. Its initial indications included blood sugar regulation and risk reduction for cardiovascular events.

As of 2023, EMPAGLIFLOZIN has a significant market share within the SGLT2 class. It competes primarily with drugs like dapagliflozin (Farxiga) and canagliflozin (Invokana). Its global sales exceeded $4 billion in 2022, according to IQVIA data, accounting for approximately 35% of the SGLT2 inhibitor segment.

Key Market Metrics (2022-2023)

Metric	2022	2023 (Projected)	Source
Global sales	$4.2 billion	$4.5 billion	IQVIA
Market share (SGLT2)	35%	36%	Evaluate Pharma
Number of prescriptions	12 million	14 million	IQVIA
Leading regions	US (55%), EU (25%), ROW (20%)	Same	IMS Health data

The North American market drives the majority of sales, owing to high prevalence of type 2 diabetes and reimbursement coverage.

How Do Regulatory and Clinical Developments Impact Market Trajectory?

Regulatory Approvals

EMPAGLIFLOZIN's approvals extend beyond glycemic control to include cardiovascular risk reductions. It received FDA approval for heart failure with reduced ejection fraction (HFrEF) in 2021. The European Medicines Agency (EMA) followed with similar approvals.

Clinical Evidence

The EMPA-REG OUTCOME trial (2015) proved the drug's cardiovascular benefits, positively influencing prescriptions long-term. Recent trials, such as EMPEROR-Reduced and EMPEROR-Preserved, reinforce its efficacy in heart failure, broadening usage.

Patent and Label Extensions

Boehringer Ingelheim’s patent protections last until 2027 in key jurisdictions, with some data exclusivity extending to 2030. Post-patent, generic competition will influence pricing and sales volume.

What Are the Competitive and Market Access Challenges?

Competition

Dapagliflozin (Farxiga), approved in 2014, holds approximately 30% market share. Canagliflozin (Invokana) is third with 20%. The race for label expansion in heart failure and chronic kidney disease (CKD) adds competitive pressure.

Pricing and Reimbursement

In the US, EMPAGLIFLOZIN's average wholesale price (AWP) is about $550 per month. Reimbursement policies and formulary placements heavily influence access. Cost-effectiveness analyses show that while the drug's price is high, its cardiovascular benefits justify premium positioning.

Biosimilar Entry

Generic versions are unlikely until late 2027 or early 2028, given patent protections. The upcoming patent expiry will introduce price competition and erode margins.

What Is the Future Revenue Outlook?

Market Expansion Factors

1. Indications: Expanding into CKD and heart failure increases potential market size. The global CKD market is expected to reach $70 billion by 2028.
2. Geographies: Emerging markets like China and India will contribute cumulatively, despite pricing pressures.
3. Patient Population: The rising prevalence of type 2 diabetes—estimated to reach 700 million globally by 2045—fuels long-term sales growth.

Financial Estimates (2023-2027)

Based on current market dynamics:

Year	Estimated Sales	CAGR	Key Drivers
2023	$4.5 billion	6.7%	Patent protection, expanded labels
2024	$4.8 billion	6.7%	New approvals, increased adoption
2025	$5.2 billion	8.3%	Genomic insights, guideline updates
2026	$5.6 billion	7.7%	Generic competition approaching
2027	$6.0 billion	7.1%	Transition to biosimilars begins

What Are the Risks to Market and Financial Trajectory?

• Patent Cliff: Patent expiry in 2027 could significantly reduce prices.
• Generics: Entry of biosimilars will erode margins; early lifecycle management strategies become critical.
• Regulatory Shifts: Changes in prescribing guidelines or reimbursement policies could diminish sales.
• Market Saturation: High penetration in developed markets limits growth potential domestically.

Key Takeaways

EMPAGLIFLOZIN remains a leading product within the SGLT2 class, driven by expanding indications and cardiovascular benefits. The upcoming patent expiration in 2027 presents a major inflection point, with biosimilar entry likely to diminish revenue. Market growth hinges on regulatory approvals, new indications, and competitive strategies, especially within emerging markets.

FAQs

Q1: When does EMPAGLIFLOZIN's patent protection expire?
It is scheduled to expire in 2027 in major markets, after which biosimilars are expected to enter.

Q2: What is the major driver of EMPAGLIFLOZIN’s sales growth?
Expansion into heart failure and CKD indications, along with the global rise in diabetes prevalence.

Q3: How does EMPAGLIFLOZIN compare competitively?
It holds approximately 35% of the SGLT2 market share, slightly ahead of dapagliflozin at 30%.

Q4: What are the primary risks affecting its future sales?
Patent expiration, biosimilar competition, regulatory changes, and pricing pressures.

Q5: What is the long-term outlook for EMPAGLIFLOZIN sales?
Moderate growth projected through 2026, with a potential decline post-2027 unless new indications or formulations are introduced.

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References

1. IQVIA. (2022). Pharmaceutical Market Analysis.
2. Evaluate Pharma. (2023). Global Diabetes Market Data.
3. FDA. (2014). Approval of EMPAGLIFLOZIN for Type 2 Diabetes.
4. EMA. (2021). EMPAGLIFLOZIN approvals in cardiovascular indications.
5. Boehringer Ingelheim. (2023). Corporate Investment and Patent Strategy.