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 ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Empagliflozin; metformin hydrochloride has two hundred and sixty-one patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for empagliflozin; metformin hydrochloride

International Patents:	261
US Patents:	10
Tradenames:	3
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	69
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
Novo Nordisk A/S	Phase 3
SINA Health Education and Welfare Trust	Phase 2/Phase 3
Horizon Pharmaceutical Pvt Ltd	Phase 4

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	11,813,275
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-003	Aug 26, 2015		RX	Yes	No
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-001	Aug 26, 2015		RX	Yes	No
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-001	Aug 26, 2015		RX	Yes	No	7,579,449*PED				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-001	Aug 26, 2015		RX	Yes	No	10,610,489*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No	9,949,998*PED				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	208658-003	Dec 9, 2016	6,488,962
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016	6,488,962
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016	6,488,962
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016	6,488,962

International Patents for empagliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Taiwan	I323264
Hungary	S1400056
Japan	2008208127	GLUOCOPYRANOSYL-SUBSTITUTED PHENYL DERIVATIVE, MEDICAMENT CONTAINING THE COMPOUND, ITS USE AND PROCESS FOR PRODUCING THE SAME
South Korea	101174726
Argentina	048041	DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, COMPOSICIONES FARMACEUTICAS Y PROCEDIMIENTO PARA SU PREPARACION
Germany	102004012676	Glucopyranosyl-substituierte Phenyle, diese Verbindungen enthaltende Arzneimittel, deren Verwendung und Verfahren zu ihrer Herstellung (New glucopyranosyl-substituted benzene derivatives are sodium-dependent glucose cotransporter inhibitors, useful for treating e.g. metabolic disorders (type 1 and type 2 diabetes mellitus or metabolic acidosis))

Supplementary Protection Certificates for empagliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	CR 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
1730131	C01730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
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
1730131	C01730131/04	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1730131	568	Finland

Empagliflozin; metformin hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Empagliflozin and Metformin Hydrochloride

Introduction to Empagliflozin and Metformin Hydrochloride

Empagliflozin and metformin hydrochloride are key components in the treatment of type 2 diabetes, heart failure, and chronic kidney disease (CKD). Empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, works by reducing glucose reabsorption in the kidneys, while metformin hydrochloride is a well-established medication for lowering blood sugar levels. The combination of these two drugs has become a cornerstone in modern diabetes management.

Global Market Size and Growth

The global market for SGLT2 inhibitors, which includes empagliflozin, is projected to experience significant growth. As of 2023, the global SGLT2 inhibitors market was estimated at USD 15.85 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.71% from 2024 to 2030[1].

For empagliflozin tablets specifically, the market size was valued at USD 91.17 billion in 2023 and is projected to reach USD 176.51 billion by 2031, growing at a CAGR of 8.2% during the forecast period[3].

Key Drivers of Market Growth

Increasing Incidence of Type 2 Diabetes

The rising global incidence of type 2 diabetes is a primary driver of the market growth for empagliflozin and metformin hydrochloride. According to health organizations, millions of people worldwide are afflicted by diabetes each year, creating a high demand for effective treatments[3].

R&D and New Formulations

Continuous research and development (R&D) efforts have led to the development of new and improved formulations of SGLT2 inhibitors. For instance, the EMPACT-MI phase 3 clinical trial showed a 10% risk reduction in hospitalized heart failure patients after using empagliflozin, which is expected to boost demand for these drugs[1].

Positive Regulatory Environment

The favorable regulatory environment plays a crucial role in the market growth. The U.S. FDA and EMA have accelerated approval processes for new diabetes drugs that demonstrate clinical efficacy and safety. The recent approval of Jardiance (empagliflozin) for reducing cardiovascular mortality and CKD hospitalization further enhances market confidence[3].

Expanded Indications

Empagliflozin is not only used for type 2 diabetes but also for heart failure and CKD. Recent studies have shown that empagliflozin can lower hospitalization rates and improve cardiovascular outcomes, making it a valuable treatment option for a broader range of health issues[3].

Market Segments and Distribution Channels

Indication Outlook

The market for empagliflozin and metformin hydrochloride is segmented based on indications such as type 2 diabetes, cardiovascular diseases, and CKD. The treatment of type 2 diabetes remains the primary indication, but the drug's benefits in heart failure and CKD are increasingly recognized and driving growth[1].

Distribution Channels

The global market is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies are expected to play a significant role due to the rising presence of affordable drugs across these outlets[4].

Regional Outlook

North America

North America, particularly the U.S., is a significant market for empagliflozin and metformin hydrochloride. The region benefits from advanced healthcare infrastructure and high awareness of diabetes management, contributing to strong market growth[1].

Europe

Europe is another key region, with countries like Germany and France prioritizing cutting-edge diabetic therapies. The region's strong healthcare system and increasing disposable incomes support the market's expansion[3].

Asia-Pacific

The Asia-Pacific region is expected to experience major growth due to rising disposable incomes, better access to healthcare, and growing awareness of diabetes. Countries like China, Japan, and India are driving this growth[3].

Latin America and Middle East & Africa

Latin America is expected to expand due to increased healthcare efforts and a growing focus on lifestyle diseases. The Middle East and Africa present a varied landscape, with market growth influenced by differing levels of healthcare access and affordability[3].

Financial Trajectory

Revenue Projections

The financial trajectory for empagliflozin and metformin hydrochloride is positive, driven by strong patient demand and favorable regulatory approvals. The Jardiance segment, which includes empagliflozin, dominated the market with 52.60% of the global revenue in 2023 and is anticipated to grow significantly over the forecast period[1].

Key Milestones

• Jardiance Achievements: Since its approval, Jardiance has achieved 59 million prescriptions worldwide and has contributed to extending patient lives by over 461,000 patient-life years[1].
• Government Initiatives: The inclusion of Jardiance in the “Drug Price Negotiation Program” as part of the Inflation Reduction Act (IRA) by the Centers for Medicare and Medicaid Services (CMS) is expected to drive segment growth[1].

Challenges and Opportunities

Side Effects and Market Competition

Despite the positive financial trajectory, the market faces challenges such as potential side effects and market competition. However, strong patient demand and the drug's clinical efficacy continue to drive its financial success[5].

Customized Treatment Approaches

The emphasis on customized treatment approaches, including the use of empagliflozin for heart failure and CKD, presents significant opportunities for market growth. As healthcare frameworks prioritize disease management and patient quality of life, the adoption of SGLT2 inhibitors like empagliflozin is expected to increase[3].

Key Takeaways

• The global market for SGLT2 inhibitors, including empagliflozin, is projected to grow significantly due to increasing incidence of type 2 diabetes and favorable regulatory environments.
• Empagliflozin and metformin hydrochloride are key treatments for type 2 diabetes, heart failure, and CKD, with expanded indications driving market growth.
• The market is segmented by indications and distribution channels, with retail pharmacies playing a crucial role.
• Regional growth is driven by North America, Europe, and the Asia-Pacific region, with varying opportunities and challenges in Latin America and the Middle East & Africa.
• The financial trajectory is positive, with strong patient demand and government initiatives supporting market expansion.

FAQs

Q: What is the projected market size for empagliflozin tablets by 2031?

The empagliflozin tablets market is projected to reach USD 176.51 billion by 2031, growing at a CAGR of 8.2% during the forecast period[3].

Q: What are the primary indications for empagliflozin and metformin hydrochloride?

The primary indications include type 2 diabetes, heart failure, and chronic kidney disease (CKD)[1][3].

Q: Which region is expected to experience major growth in the empagliflozin market?

The Asia-Pacific region is expected to experience major growth due to rising disposable incomes, better access to healthcare, and growing awareness of diabetes[3].

Q: What is the impact of government initiatives on the market for empagliflozin?

Government initiatives, such as the inclusion of Jardiance in the “Drug Price Negotiation Program” by CMS, are expected to drive segment growth and increase market confidence[1].

Q: How does the combination of empagliflozin and metformin hydrochloride benefit patients?

The combination benefits patients by regulating blood sugar levels, reducing glucose reabsorption in the kidneys, and providing additional benefits in heart failure and CKD management[2][3].

Sources

1. Grand View Research: SGLT2 Inhibitors Market Size, Share & Growth Report, 2030.
2. Synapse: Empagliflozin/metformin Hydrochloride - Drug Targets, Indications.
3. Verified Market Research: Empagliflozin Tablets Market Size, Scope, Trends and Forecast.
4. Fortune Business Insights: Diabetes Drugs Market Share, Growth | Global Report [2032].
5. DrugPatentWatch: SYNJARDY XR Drug Patent Profile.