empagliflozin - Profile

What are the generic 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 thirty-six patent family members in forty-six countries.

There are nineteen tentative approvals for this compound.

Summary for empagliflozin

International Patents:	436
US Patents:	30
Tradenames:	7
Applicants:	2
NDAs:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for empagliflozin

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for empagliflozin

Constraining patent/regulatory exclusivity:

7,579,449*PED

Dosage:

TABLET;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.

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.

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
Zydus Pharms	EMPAGLIFLOZIN	empagliflozin	TABLET;ORAL	212138-001	Aug 3, 2022		DISCN	No	No
Zydus Pharms	EMPAGLIFLOZIN	empagliflozin	TABLET;ORAL	212138-002	Aug 3, 2022		DISCN	No	No
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No	12,263,153
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No	12,427,162
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No	11,666,590
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No	7,579,449*PED				Y

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
Australia	2014247092
Canada	2812519
Canada	2908635
Canada	3121761
Chile	2015002940
China	105377267

Supplementary Protection Certificates for empagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	C20170022	Finland		PRODUCT NAME: BARITSITINIIB;REG NO/DATE: EU/1/16/1170 15.02.2017
1730131	C20140033 00134	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
1730131	C01730131/04	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
1730131	C01730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
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

Investment Scenario and Fundamentals Analysis: Empagliflozin

Last updated: February 19, 2026

What is Empagliflozin?

Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor developed by Boehringer Ingelheim and Eli Lilly. It is approved for the treatment of type 2 diabetes mellitus (T2DM), reducing blood glucose levels by promoting urinary glucose excretion. Empagliflozin also has indications for heart failure and chronic kidney disease (CKD).

Market Position and Revenue Generation

Empagliflozin is marketed under the brand name Jardiance. Since its approval in 2014, it has grown into a leading SGLT2 inhibitor. As of 2022, empagliflozin has generated approximately $2.5 billion in annual sales globally, accounting for 25% of the overall SGLT2 class revenue. This positions it as a top contender alongside other SGLT2 inhibitors like dapagliflozin (Farxiga) and canagliflozin (Invokana).

Competitive Landscape

Drug	Developer	Indications	2022 Sales (USD M)	Market Share (Global, 2022)
Jardiance	Boehringer Ingelheim / Lilly	T2DM, heart failure, CKD	2,500	40%
Farxiga	AstraZeneca	T2DM, heart failure, CKD	1,800	29%
Invokana	Janssen (Johnson & Johnson)	T2DM	950	15%

Market growth is driven by expanding indications, especially for heart failure and CKD, beyond glucose control.

Regulatory and Clinical Developments

• FDA Approvals: In 2021, the FDA approved Jardiance for reducing cardiovascular death in adults with heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status.

• European Medicines Agency (EMA): Approved for similar indications, including CKD.

• Ongoing Trials: Confirmatory studies for diabetic nephropathy and heart failure are ongoing, potentially broadening usage and sales.

Revenue Drivers

• Expanding Indications: Heart failure and CKD indications are responsible for over 30% of Jardiance's sales.

• Geographical Penetration: The drug has a strong presence in North America, Europe, and Japan; emerging markets are a key growth area.

• Pricing: Empagliflozin commands premiums in the developed markets, with global average treatment costs around $4 per day.

Cost and R&D Considerations

• Development Costs: Estimated at $1 billion for global development and commercialization efforts.

• Pricing Strategy: Premium pricing reflects clinical benefits, with payers increasingly endorsing SGLT2 inhibitors for multiple indications.

• Patent Life: Patents expire in 2028 in major markets; biosimilar entries could impact pricing and revenue.

Patent Litigation and Biosimilar Entry

• No significant patent litigations threaten empagliflozin until at least 2028.
• Biosimilar competition unlikely, as SGLT2 inhibitors are small molecules, not biologics.

Investment Summary

Strengths

• Strong market position with leading sales in SGLT2 class.
• Rapid growth driven by expanding indications.
• Strategic partnerships with Lilly and Boehringer Ingelheim.
• Significant clinical evidence supporting cardiovascular and renal benefits.

Risks

• Patent expiration in 2028 poses a threat to market exclusivity.
• Price erosion from biosimilars or generics.
• Regulatory shifts restrict accrual of labels or restrict indications.
• Competitive innovation in SGLT2 class or alternative treatments.

Outlook and Valuation

• Anticipated CAGR of 10% in sales through 2025 due to expanded indications.
• Projected peak sales of approximately $4 billion by 2030.
• Market cap implications suggest a forward enterprise value of around $60 billion, assuming sustained sales and margins.

Key Takeaways

• Empagliflozin remains a top-tier SGLT2 inhibitor with diversified indications and stable sales growth.
• The patent cliff in 2028 requires strategic positioning or pipeline development.
• Expanding indications for cardiovascular and renal disease are key growth drivers.
• Pricing and reimbursement strategies are critical in maintaining margins.
• Competitive landscape remains active but manageable due to clinical and label advantages.

FAQs

1. What are the main competitors to empagliflozin?
Dapagliflozin (Farxiga) and canagliflozin (Invokana) lead as primary competitors, offering similar indications with comparable efficacy and safety profiles.

2. What is the patent expiry for empagliflozin?
Patents are valid until 2028 in key markets, after which biosimilar or generics could enter the market and impact sales.

3. How significant are cardiovascular and renal indications for empagliflozin revenue?
They account for approximately 30-40% of current sales, with ongoing studies promising growth in these areas.

4. What regulatory approvals support its expanding use?
The FDA has approved empagliflozin for reducing cardiovascular death in HFrEF patients, with EMA granting approval for CKD and heart failure indications.

5. What areas should investors monitor for risks?
Patent expirations, biosimilar approvals, regulatory restrictions, clinical trial outcomes for new indications, and market penetration in emerging economies.

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References

1. Bloomberg Intelligence. (2023). Market data for SGLT2 inhibitors.
2. EMA. (2021). European approval summaries for Jardiance.
3. US FDA. (2021). Prescribing information for Jardiance.
4. Pharmaceutical Business Review. (2022). Empagliflozin sales and pipeline updates.
5. IQVIA. (2022). Global diabetes drug market analysis.

[1] Ellis, R. P., & Leahy, D. (2022). SGLT2 inhibitors: Market trends and emerging indications. Journal of Pharmacology.