JARDIANCE Drug Patent Profile

When do Jardiance patents expire, and what generic alternatives are available?

Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Jardiance

Jardiance was eligible for patent challenges on August 1, 2018.

Annual sales in 2021 were $7.6bn, indicating a strong incentive for generic entry.

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are fourteen tentative approvals for the generic drug (empagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for JARDIANCE

International Patents:	280
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	75
Patent Applications:	698
Drug Prices:	Drug price information for JARDIANCE
Drug Sales Revenues:	Drug sales revenues for JARDIANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JARDIANCE
What excipients (inactive ingredients) are in JARDIANCE?	JARDIANCE excipients list
DailyMed Link:	JARDIANCE at DailyMed

See drug prices for JARDIANCE

See drug sales revenues for JARDIANCE

Recent Clinical Trials for JARDIANCE

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
Rigshospitalet, Denmark	Phase 4
Novo Nordisk A/S	Phase 3

See all JARDIANCE clinical trials

Pharmacology for JARDIANCE

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

Paragraph IV (Patent) Challenges for JARDIANCE

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 JARDIANCE

JARDIANCE is protected by twelve US patents and six FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes
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
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes	9,949,998*PED				Y
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No	7,713,938*PED				Y

EU/EMA Drug Approvals for JARDIANCE

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 JARDIANCE

When does loss-of-exclusivity occur for JARDIANCE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering JARDIANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Tunisia	2011000415	PHARMACEUTICAL COMPOSITION COMPRISING A SGLT2 INHIBITOR A DPP-I V INHIBITOR AND OPTIONALLY A FURTHER ANTIDIABETIC AGENT AND USES THEREOF
Ecuador	SP109977	Composición farmacéutica que comprende un derivado de benceno sustituido con glucopiranosilo.
Hong Kong	1215378	藥物組合物、治療方法及其用途 (PHARMACEUTICAL COMPOSITION, METHODS FOR TREATING AND USES THEREOF)
European Patent Office	1828216	DERIVES DE BENZENE SUBSTITUES PAR GLUCOPYRANOSYLE, MEDICAMENTS CONTENANT CES COMPOSES, LEUR UTILISATION ET LEUR PROCEDE DE FABRICATION (GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVES, MEDICAMENTS CONTAINING SUCH COMPOUNDS, THEIR USE AND PROCESS FOR THEIR MANUFACTURE)
Cyprus	1121203
Spain	2602748

Supplementary Protection Certificates for JARDIANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	200 5026-2014	Slovakia		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
2187879	2017020	Norway		PRODUCT NAME: EMPAGLIFLOZIN OG LINAGLIPTIN; REG. NO/DATE: EU/1/16/1146-001-018 20161209
2187879	LUC00017	Luxembourg		PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115
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	C20140033 00134	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014

JARDIANCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Jardiance

Introduction

Jardiance, developed by Boehringer Ingelheim and Eli Lilly, is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that has revolutionized the treatment of type 2 diabetes and other related conditions. Here, we delve into the market dynamics and financial trajectory of this pivotal drug.

Market Size and Growth

The global SGLT2 inhibitors market, dominated by Jardiance, was estimated at USD 15.85 billion in 2023. This market is projected to grow at a CAGR of 7.71% from 2024 to 2030, driven primarily by the increasing incidence of type 2 diabetes worldwide[1].

Dominance of Jardiance

Jardiance accounted for 52.60% of the global revenue in the SGLT2 inhibitors market in 2023. Its dominance is attributed to its efficacy in treating patients with type 2 diabetes and reducing the risk of heart failure. 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].

Financial Performance

In the third quarter of 2023, Jardiance revenue increased by 22% compared to the same period in 2022, reaching $700.8 million worldwide, with U.S. revenue at $415.9 million. For the fourth quarter of 2023, worldwide Jardiance revenue increased by 30% compared to the fourth quarter of 2022, reaching $798.1 million, with U.S. revenue at $468.9 million[2][5].

Annual Sales

In 2022, Jardiance generated 5.8 billion euros ($6.1 billion) in sales, representing a 39% increase from 2021. This significant growth was fueled by approvals for treating both major types of heart failure (HF) in 2021 and 2022[4].

Key Drivers of Growth

Heart Failure Indications

The approvals for heart failure with reduced ejection fraction in August 2021 and for heart failure with preserved ejection fraction in February 2022 have significantly boosted Jardiance sales. These indications have opened up a large patient population, contributing to the drug's robust growth[4].

Chronic Kidney Disease

Jardiance has also shown efficacy in preventing the decline in kidney function, end-stage kidney disease, death, and hospitalization in patients with chronic kidney disease. This expanded indication further enhances its market potential[3].

Pediatric Approval

Recent trials have demonstrated Jardiance's effectiveness in reducing blood sugar levels in children and adolescents with type 2 diabetes, paving the way for additional approvals and market expansion[4].

Regulatory and Government Initiatives

Medicare Drug Price Negotiation

The inclusion of Jardiance in Medicare's Drug Price Negotiation Program under the Inflation Reduction Act (IRA) is expected to improve access to the drug and drive market competition. This initiative by government organizations is anticipated to support segment growth during the forecast period[1][3].

Impact on Patient Outcomes

Jardiance has been shown to reduce the risk of death and hospitalization, prevent decline in kidney function, and improve quality of life scores. Its once-daily dosage helps in improving adherence and outcomes for patients with multiple conditions such as diabetes, heart disease, and chronic kidney disease[3].

Research and Development

Boehringer Ingelheim invested 5.05 billion euros in R&D in 2022, up from 4.13 billion euros in 2021. This increased investment is aimed at supporting late-stage pipeline projects and mid-term growth opportunities, further solidifying Jardiance's market position[4].

Competitive Landscape

While Jardiance dominates the SGLT2 inhibitors market, other drugs and treatments are also evolving. However, Jardiance's broad range of indications and proven efficacy continue to make it a leader in the market.

Financial Outlook

Eli Lilly's financial results highlight the strong sales growth of Jardiance. The company's overall revenue and net income have seen significant increases, partly due to the performance of Jardiance. For 2023, Lilly reported a revenue of $34.124 billion, a 20% increase from 2022, with Jardiance contributing substantially to this growth[5].

Conclusion

Jardiance's market dynamics are characterized by strong growth driven by its efficacy in treating type 2 diabetes and related conditions, along with significant regulatory support. The financial trajectory of Jardiance is robust, with continuous increases in revenue and a dominant market position.

Key Takeaways

• Market Dominance: Jardiance dominates the SGLT2 inhibitors market with 52.60% of global revenue.
• Financial Growth: Jardiance revenue has seen significant increases, with a 22% and 30% growth in Q3 and Q4 2023, respectively.
• Heart Failure Indications: Approvals for heart failure have substantially boosted sales.
• Chronic Kidney Disease: Efficacy in treating chronic kidney disease expands its market potential.
• Regulatory Support: Inclusion in Medicare's Drug Price Negotiation Program enhances access and competition.
• Patient Outcomes: Improves quality of life and reduces risk of death and hospitalization.

FAQs

Q: What is the current market size of the SGLT2 inhibitors market? A: The global SGLT2 inhibitors market was estimated at USD 15.85 billion in 2023[1].

Q: How much revenue did Jardiance generate in 2022? A: Jardiance generated 5.8 billion euros ($6.1 billion) in sales in 2022[4].

Q: What are the key drivers of Jardiance's growth? A: Key drivers include heart failure indications, efficacy in chronic kidney disease, and recent pediatric approvals[3][4].

Q: How has Jardiance impacted patient outcomes? A: Jardiance reduces the risk of death and hospitalization, prevents decline in kidney function, and improves quality of life scores[3].

Q: What regulatory initiatives support Jardiance's market growth? A: Inclusion in Medicare's Drug Price Negotiation Program under the Inflation Reduction Act (IRA) supports market growth[1][3].

Sources

1. Grand View Research - SGLT2 Inhibitors Market Size, Share & Growth Report, 2030
2. PR Newswire - Lilly Reports Third-Quarter 2023 Financial Results, Highlights Strong Sales Growth and Business Development Activity
3. CMS - Jardiance, November 8, 2023 Medicare Drug Price Negotiation
4. FiercePharma - Heart failure approvals help BI, Lilly's Jardiance rake in $6.3B
5. Eli Lilly - Lilly Reports Strong Fourth-Quarter 2023 Financial Results and