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 twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin has two hundred and eighty patent family members in forty-five countries.

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

Summary for EMPAGLIFLOZIN

International Patents:	280
US Patents:	24
Tradenames:	7
Applicants:	2
NDAs:	7
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	328
Patent Applications:	1,475
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
University of Texas Southwestern Medical Center	Phase 1/Phase 2
Diabetes Canada	Phase 4
Rigshospitalet, Denmark	Phase 4

See all EMPAGLIFLOZIN clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		25MG;5MG	TABLET;ORAL
		25MG	TABLET;ORAL
		10MG	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	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-003	Aug 26, 2015		RX	Yes	No	11,090,323*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No	11,833,166
Zydus Pharms	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	empagliflozin; metformin hydrochloride	TABLET;ORAL	212198-001	Jul 7, 2022		DISCN	No	No
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No	11,813,275
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	8,551,957*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	11,090,323*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/002677 Type 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
Taiwan	200914030	Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
South Korea	101249711
Argentina	077512	DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, MEDICAMENTOS QUE CONTIENEN ESOS COMPUESTOS, SU APLICACION Y PROCEDIMIENTO PARA SU PREPARACION
Canada	2908621	UTILISATIONS THERAPEUTIQUES D'EMPAGLIFLOZINE (THERAPEUTIC USES OF EMPAGLIFLOZIN)
Mexico	2010001696	COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO. (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTE D BENZENE DERIVATIVE.)
World Intellectual Property Organization (WIPO)	2005092877
Denmark	1888552

Supplementary Protection Certificates for EMPAGLIFLOZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	CA 2017 00019	Denmark		PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
1730131	122014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	92555	Luxembourg		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL
2187879	LUC00017	Luxembourg		PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115
2187879	PA2017014	Lithuania		PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO DERINYS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111
2187879	2017020	Norway		PRODUCT NAME: EMPAGLIFLOZIN OG LINAGLIPTIN; REG. NO/DATE: EU/1/16/1146-001-018 20161209
1730131	C01730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014

EMPAGLIFLOZIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Empagliflozin

Market Size and Growth

The market for empagliflozin, along with other SGLT2 inhibitors like dapagliflozin and canagliflozin, has been experiencing steady growth. As of 2023, the market size was valued at $9.41 billion and is projected to reach $9.64 billion in 2024, with a compound annual growth rate (CAGR) of 2.4%[1][3].

By 2028, the market is expected to grow to $10.78 billion at a CAGR of 2.8%, driven by increasing demand for oral diabetes medications, growing investments in diabetes research, increased healthcare spending, and a greater emphasis on combination therapies[1][3].

Drivers of Market Growth

Several factors are driving the growth of the empagliflozin market:

• Increasing Prevalence of Type 2 Diabetes: The global rise in type 2 diabetes cases is a significant driver, as more patients require effective treatment options[1][3].
• Awareness of SGLT2 Inhibitors: Greater awareness among healthcare providers and patients about the benefits of SGLT2 inhibitors, such as empagliflozin, is boosting demand[1][3].
• Aging Population: The growth in the elderly population, who are more prone to diabetes and related complications, is another key factor[1][3].
• Obesity Rates: Increasing obesity rates, which are closely linked to the development of type 2 diabetes, also contribute to market growth[1][3].
• Personalized Medicine: A heightened focus on personalized medicine is leading to more tailored treatment approaches, including the use of empagliflozin[1][3].

Financial Impact and Cost Savings

The financial impact of incorporating empagliflozin into treatment regimens is multifaceted:

• Drug Acquisition Costs: While the addition of empagliflozin increases drug acquisition costs, it also leads to significant savings in other areas. For example, in Malaysia, the total cost with empagliflozin rose by 0.71%, but this was offset by savings from reduced heart failure hospitalizations, fewer cardiovascular deaths, and improved renal outcomes[2].
• Savings from Reduced Hospitalizations: Studies have shown that empagliflozin can reduce heart failure hospitalizations, leading to substantial cost savings. In one analysis, the reduction in hospitalizations contributed to 62.6% of the cost savings[2].
• Cost Savings from Reduced Cardiovascular Deaths and Renal Outcomes: Empagliflozin also results in cost savings from reduced cardiovascular deaths and improved renal outcomes. For instance, in Malaysia, the average annual savings from these improvements were significant, offsetting a large portion of the increased drug costs[2].

Budget Impact Analysis

A budget impact analysis conducted from the perspective of the Malaysian Ministry of Health highlighted that the addition of empagliflozin to guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) requires a net annual investment but is largely compensated by cost savings from clinical improvements.

• Key Factors Influencing Budget Impact: The analysis identified the cost of empagliflozin, expenses associated with heart failure hospitalizations, and the incidence of cardiovascular mortality as key factors influencing the budget impact. A 20% reduction in the price of empagliflozin could result in significant cost savings[2].

Regional Market Dynamics

The empagliflozin market is segmented across various regions, each with its own dynamics:

• North America: This region was the largest market for empagliflozin, dapagliflozin, and canagliflozin in 2023. The market here is driven by high healthcare spending and a large patient population[3].
• Asia-Pacific: This region is expected to see significant growth due to the increasing prevalence of diabetes and growing healthcare investments[1][3].
• Europe: Both Western and Eastern Europe are important markets, with growth influenced by demographic changes, healthcare policies, and economic conditions[1][3].

Trends and Strategies

Several trends and strategies are shaping the empagliflozin market:

• Technological Advancements: Continuous advancements in technology are improving the efficacy and safety of SGLT2 inhibitors[1][3].
• Combination Therapies: There is a growing emphasis on combination therapies, which include empagliflozin, to provide more comprehensive treatment options for patients with diabetes and related conditions[1][3].
• Telehealth and Health Data Analytics: The integration of telehealth services and health data analytics is enhancing patient care and treatment outcomes, further driving the market[1][3].
• Patient Data Security: With the increasing use of digital health technologies, ensuring patient data security is becoming a critical focus area[1][3].

Competitive Landscape

The market for empagliflozin is competitive, with several major pharmaceutical companies involved:

• Market Shares: Companies like Boehringer Ingelheim and Eli Lilly, which market empagliflozin under the brand name Jardiance, hold significant market shares. Other companies, such as AstraZeneca and Janssen, also play important roles with their respective SGLT2 inhibitors[1][3].

Macro Economic Scenario

The market is influenced by various macroeconomic factors:

• Impact of High Inflation: High inflation can affect the affordability and accessibility of empagliflozin, particularly in regions with stringent healthcare budgets[1].
• Ukraine-Russia War: The conflict has impacted supply chains and economic stability in Eastern Europe, affecting the overall market dynamics[1][3].
• COVID-19 Impact: The pandemic has accelerated the adoption of telehealth and health data analytics, but it has also posed challenges in terms of supply chain disruptions and altered demand patterns[1][3].

Key Takeaways

• The empagliflozin market is growing steadily, driven by increasing demand for oral diabetes medications and growing awareness of SGLT2 inhibitors.
• The market is expected to reach $10.78 billion by 2028, with a CAGR of 2.8%.
• Empagliflozin offers significant cost savings through reduced hospitalizations, cardiovascular deaths, and improved renal outcomes.
• Regional dynamics, technological advancements, and combination therapies are key trends shaping the market.
• Macro-economic factors such as inflation, the Ukraine-Russia war, and the COVID-19 pandemic also influence market growth.

FAQs

Q: What is the current market size of empagliflozin, dapagliflozin, and canagliflozin?

The current market size of empagliflozin, dapagliflozin, and canagliflozin was $9.41 billion in 2023[1][3].

Q: What is the projected growth rate of the empagliflozin market?

The market is expected to grow at a CAGR of 2.8% from 2023 to 2028, reaching $10.78 billion by 2028[1][3].

Q: What are the key drivers of the empagliflozin market growth?

Key drivers include the increasing prevalence of type 2 diabetes, greater awareness of SGLT2 inhibitors, an expanding elderly population, increasing obesity rates, and a focus on personalized medicine[1][3].

Q: How does empagliflozin impact healthcare costs?

Empagliflozin can reduce healthcare costs through reduced heart failure hospitalizations, fewer cardiovascular deaths, and improved renal outcomes, offsetting the increased drug acquisition costs[2].

Q: What are the major trends shaping the empagliflozin market?

Major trends include technological advancements, combination therapies, telehealth, health data analytics, and enhanced patient data security[1][3].

Sources

1. The Business Research Company, "Empagliflozin, Dapagliflozin And Canagliflozin Global Market Report 2024"
2. PLOS ONE, "Evaluating the budget impact of Empagliflozin in managing heart failure with reduced ejection fraction"
3. The Business Research Company, "Empagliflozin, Dapagliflozin And Canagliflozin Global Market Report 2024"
4. Verified Market Research, "Empagliflozin Dapagliflozin And Canagliflozin Market Size, Scope"