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GLYXAMBI Drug Patent Profile

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

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

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

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.

DrugPatentWatch^® Generic Entry Outlook for Glyxambi

Glyxambi was eligible for patent challenges on May 2, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2030. This may change due to patent challenges or generic licensing.

There have been nineteen 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 three tentative approvals for the generic drug (empagliflozin; linagliptin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for GLYXAMBI

International Patents:	562
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	7
Drug Prices:	Drug price information for GLYXAMBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLYXAMBI
What excipients (inactive ingredients) are in GLYXAMBI?	GLYXAMBI excipients list
DailyMed Link:	GLYXAMBI at DailyMed

See drug prices for GLYXAMBI

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

Constraining patent/regulatory exclusivity:

8,551,957*PED

NDA:

206073

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.

Pharmacology for GLYXAMBI

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for GLYXAMBI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLYXAMBI	Tablets	empagliflozin; linagliptin	10 mg/5 mg and 25 mg/5 mg	206073	9	2018-08-01

US Patents and Regulatory Information for GLYXAMBI

GLYXAMBI is protected by thirteen US patents.

This potential generic entry date is based on patent 8,551,957.

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

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	9,173,859		Y		Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes	7,713,938*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes	10,258,637*PED				Y

Expired US Patents for GLYXAMBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	7,459,428
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	8,178,541
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015	8,119,648

EU/EMA Drug Approvals for GLYXAMBI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Glyxambi	empagliflozin, linagliptin	EMEA/H/C/003833 Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.	Authorised	no	no	no	2016-11-11

International Patents for GLYXAMBI

When does loss-of-exclusivity occur for GLYXAMBI?

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 GLYXAMBI around the world.

Country	Patent Number	Title	Estimated Expiration
China	105377267	Therapeutic uses of empagliflozin
World Intellectual Property Organization (WIPO)	2006064033
Brazil	PI0722388	Forma de dosagem oral farmacêutica preparada com uma composição farmacêutica compreendendo composto inibidor de dpp iv

Supplementary Protection Certificates for GLYXAMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	11C0052	France		PRODUCT NAME: LINAGLIPTINE SES ENANTIOMERES ET SELS; REGISTRATION NO/DATE: EU/1/11/707/001 20110830
1730131	C01730131/04	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
0896538	07C0035	France		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321

GLYXAMBI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Glyxambi

Introduction

Glyxambi, a medication developed by Boehringer Ingelheim and Eli Lilly, is used to treat type 2 diabetes by improving blood glucose control. This article delves into the market dynamics and financial trajectory of Glyxambi, highlighting key factors influencing its growth and performance.

Market Overview of Antidiabetic Drugs

The global antidiabetic drugs market is driven by several key factors, including the increasing prevalence of diabetes, rising healthcare expenditure, and technological advancements. The growing rates of diabetes, coupled with unhealthy lifestyles and rising obesity rates, have accelerated the growth of this market[1].

Glyxambi: A Dual-Action Medication

Glyxambi is a combination of empagliflozin (an SGLT2 inhibitor) and linagliptin (a DPP-4 inhibitor), making it a dual-action medication effective in controlling blood glucose levels. The European Medicines Agency (EMA) approved Glyxambi in 2016, recognizing its benefits in managing type 2 diabetes[4].

Market Growth Drivers

Increasing Prevalence of Diabetes

The rising incidence of diabetes globally is a significant driver for the antidiabetic drugs market, including Glyxambi. As the population grows and lifestyles become increasingly unhealthy, the demand for effective diabetes treatments is on the rise[1].

Technological Advancements

Advancements in pharmaceutical technology have led to the development of more effective and tolerable treatments. Glyxambi, with its dual-action mechanism, is a testament to these advancements, offering improved glycemic control with a favorable safety profile[1].

Awareness and Education

Campaigns and education programs by diabetes associations and societies have raised awareness about diabetes control, further stimulating the demand for antidiabetic medications like Glyxambi[1].

Financial Performance of Key Players

Boehringer Ingelheim and Eli Lilly

Boehringer Ingelheim and Eli Lilly, the developers of Glyxambi, have seen significant financial growth in recent years. For instance, Eli Lilly reported strong financial results in Q4 2023, with revenue increasing by 28% to $9.353 billion. This growth is partly attributed to the success of their diabetes and obesity treatments, including those like Glyxambi[2].

Revenue Contribution

While specific revenue figures for Glyxambi are not isolated, the overall revenue growth of Eli Lilly and other key players in the antidiabetic market indicates a positive financial trajectory. The launch of new drugs and the continued success of existing ones contribute to this growth. For example, Eli Lilly's new products revenue grew by $2.19 billion to $2.49 billion in Q4 2023, reflecting the market's demand for innovative treatments[2].

Regional Market Dynamics

Europe

Europe accounts for a significant share of the antidiabetic drugs market, with a 26.3% share in 2020. The region is expected to grow at a rate of 10.2% during the forecast period, driven by the rising population and an emerging healthcare network[1].

Asia-Pacific (APAC)

The APAC region is anticipated to grow at the highest rate of 10.5% during the forecast period. This growth is driven by the rising population and the development of healthcare infrastructure in countries like China and India[1].

Competitive Landscape

Glyxambi operates in a competitive market dominated by several key players, including Novartis, Bayer Corporation, Johnson & Johnson, Pfizer, AstraZeneca, and Novo Nordisk. The market is characterized by a high level of competition, with companies continuously innovating and launching new products to capture market share[1].

Pricing and Accessibility

The pricing of antidiabetic drugs, including Glyxambi, is a critical factor influencing market dynamics. High prices, especially in the US, can limit accessibility. However, the potential introduction of oral GLP-1s and increased competition may lead to lower price points, making these treatments more accessible to a broader patient population[3].

Future Outlook

Technological Innovations

The future of Glyxambi and similar antidiabetic drugs is promising, with ongoing research and development aimed at creating more effective and tolerable treatments. The emergence of oral GLP-1s, for instance, is expected to play a significant role in chronic weight management and diabetes treatment, potentially expanding the market size[3].

Market Size Projections

The global market for antidiabetic drugs, including Glyxambi, is projected to continue growing. The GLP-1 market alone is estimated to reach $100 billion globally, driven by the expanding patient population and the potential benefits of these drugs for various health conditions[3].

Key Takeaways

• Increasing Prevalence of Diabetes: The rising incidence of diabetes is a major driver for the antidiabetic drugs market.
• Technological Advancements: Innovations in pharmaceutical technology have led to more effective treatments like Glyxambi.
• Financial Growth: Key players like Eli Lilly have reported significant revenue growth, partly due to the success of their diabetes treatments.
• Regional Dynamics: Europe and the APAC region are expected to see substantial growth in the antidiabetic drugs market.
• Competitive Landscape: The market is highly competitive, with several key players innovating to capture market share.
• Pricing and Accessibility: High prices are a challenge, but potential innovations and increased competition may lead to lower price points.

FAQs

What is Glyxambi used for?

Glyxambi is used to treat type 2 diabetes by improving blood glucose control. It is a combination of empagliflozin (an SGLT2 inhibitor) and linagliptin (a DPP-4 inhibitor)[4].

Who are the key players in the antidiabetic drugs market?

Key players include Eli Lilly, Novartis, Bayer Corporation, Johnson & Johnson, Pfizer, AstraZeneca, Bristol-Myers Squibb, Oramed Pharmaceuticals, Novo Nordisk, Merck, Boehringer Ingelheim, Takeda Pharmaceutical, and Sanofi[1].

What are the main drivers of the antidiabetic drugs market?

The main drivers include the increasing prevalence of diabetes, rising healthcare expenditure, technological advancements, and growing awareness and education about diabetes control[1].

How is the pricing of Glyxambi affecting its market dynamics?

High prices, especially in the US, can limit accessibility. However, potential innovations and increased competition may lead to lower price points, making the treatment more accessible[3].

What is the projected market size for antidiabetic drugs like Glyxambi?

The global market for antidiabetic drugs, including the GLP-1 market, is estimated to reach significant figures, with the GLP-1 market alone projected to be around $100 billion globally[3].

Sources

1. Biospace: Antidiabetics Market Trends, Revenue, Key Players, Growth, Share and Forecast till 2028
2. Eli Lilly Investor Relations: Lilly Reports Strong Fourth-Quarter 2023 Financial Results and
3. Goldman Sachs: Weighing the GLP-1 market
4. European Medicines Agency: Glyxambi | European Medicines Agency (EMA)