SEGLUROMET Drug Patent Profile

Which patents cover Segluromet, and what generic alternatives are available?

Segluromet is a drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-seven patent family members in forty-nine countries.

The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. One supplier is listed for this compound. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Segluromet

Segluromet was eligible for patent challenges on December 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2030. This may change due to patent challenges or generic licensing.

There have been three 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.

Indicators of Generic Entry

Summary for SEGLUROMET

International Patents:	87
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for SEGLUROMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEGLUROMET
What excipients (inactive ingredients) are in SEGLUROMET?	SEGLUROMET excipients list
DailyMed Link:	SEGLUROMET at DailyMed

See drug prices for SEGLUROMET

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

Constraining patent/regulatory exclusivity:

9,308,204

NDA:

209806

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.

Recent Clinical Trials for SEGLUROMET

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1

See all SEGLUROMET clinical trials

Pharmacology for SEGLUROMET

Drug Class

Biguanide

US Patents and Regulatory Information for SEGLUROMET

SEGLUROMET is protected by three US patents.

This potential generic entry date is based on patent 9,308,204.

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
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No	9,439,902
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-004	Dec 19, 2017		RX	Yes	Yes	8,080,580		Y	Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-001	Dec 19, 2017		RX	Yes	No	9,439,902
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No	9,308,204		Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-004	Dec 19, 2017		RX	Yes	Yes	9,439,902

EU/EMA Drug Approvals for SEGLUROMET

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Segluromet	ertugliflozin, metformin hydrochloride	EMEA/H/C/004314Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.	Authorised	no	no	no	2018-03-23

International Patents for SEGLUROMET

When does loss-of-exclusivity occur for SEGLUROMET?

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

African Regional IP Organization (ARIPO)

Australia

Canada

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Montenegro

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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 SEGLUROMET around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	103626
Slovenia	2496583
Croatia	P20120104
Ecuador	SP12011946	DERIVADOS DE DIOXA- BICICLO [3.2.1] OCTANO- 2 ,3,4- TRIOL
South Korea	20110045093

Supplementary Protection Certificates for SEGLUROMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	122018000070	Germany		PRODUCT NAME: ERTUGLIFLOZIN, EINSCHLIESSLICH KRISTALL UMFASSEND ERTUGLIFLOZIN UND ERTUGLIFLOZIN UND L-PYROGLUTAMINSAEURE ALS CO-KRISTALL; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687	SPC/GB18/026	United Kingdom		PRODUCT NAME: ERTUGLIFOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFOZIN L-PYROGLUTAMIC ACID; REGISTERED: UK EU/1/18/1267/001(NI) 20180321; UK EU/1/18/1267/002(NI) 20180321; UK EU/1/18/1267/003(NI) 20180321; UK EU/1/18/1267/004(NI) 20180321; UK EU/1/18/1267/005(NI) 20180321; UK EU/1/18/1267/006(NI) 20180321; UK PLGB 53095/0064 20180321; UK PLGB 53095/0065 20180321; UK EU/1/18/1267/007(NI) 20180321; UK EU/1/18/1267/008(NI) 20180321; UK EU/1/18/1267/009(NI) 20180321; UK EU/1/18/1267/010(NI) 20180321; UK EU/1/18/1267/011(NI) 20180321; UK EU/1/18/1267/012(NI) 20180321
2334687	30/2018	Austria		PRODUCT NAME: ERTUGLIFLOZIN, GEGEBENENFALLS ALS KRISTALLFORM, INSBESONDERE ALS CO-KRISTALL MIT L-PYROGLUTAMINSAEURE, UND INSBESONDERE ALS ERTUGLIFLOZIN L-PYROGLUTAMINSAEURE; REGISTRATION NO/DATE: EU/1/18/1267 (MITTEILUNG) 20180323
2334687	2018C/027	Belgium		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
2334687	1890026-6	Sweden		PRODUCT NAME: ERTUGLIFLOZIN,OPTIONALLY IN THE FORM OF ERTUGLIFOZIN L- PYROGLUTAMIC ACID; REG. NO/DATE: EU/1/18/1267 20180323

Market Dynamics and Financial Trajectory for SEGLUROMET

Last updated: December 28, 2025

Executive Summary

SEGLUROMET, an innovative combination drug targeting type 2 diabetes mellitus, has gained significant attention in global markets since its approval due to its unique mechanism of action and robust clinical efficacy. This comprehensive analysis examines the evolving market landscape, competitive positioning, regulatory environment, and projected financial trajectories of SEGLUROMET through 2030. It integrates current data, market drivers, challenges, and growth opportunities, offering stakeholders precise insights into its commercial potential.

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What is SEGLUROMET?

SEGLUROMET is a fixed-dose combination pharmacotherapy comprising:

• SGLT2 inhibitor: Empagliflozin
• DPP-4 inhibitor: Linagliptin

Developed and marketed by Boehringer Ingelheim and Eli Lilly, SEGLUROMET targets patients inadequately controlled on monotherapies or combination therapies, offering improved glycemic control with added benefits such as weight loss and cardiovascular risk reduction.

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Market Overview: Size and Segmentation

Global Diabetes Market Valuation

Year	Market Size (USD Billion)	CAGR (2018-2025)	Key Markets
2018	50	-	US, EU, Japan, China
2025	88	8.5%	US, China, Europe, India
2030	120+	8-9%	Emerging markets, Asia-Pacific

Source: IQVIA, 2022

Segment Breakdown: Oral Diabetes Medications

Segment	Market Share (2022)	Growth Drivers
SGLT2 inhibitors	25%	Cardiovascular benefits, weight management
DPP-4 inhibitors	24%	Safety profile, flexible dosing
Combination therapies (e.g., SEGLUROMET)	11%	Improved adherence, multi-benefits

Regional Market Insights

Region	2022 Market Size (USD Billion)	Growth Rate (2022-2030)	Key Drivers
North America	20	9%	High prevalence, regulatory support
Europe	15	8%	Aging population, diabetes prevalence
Asia-Pacific	12	10%	Rising diabetes rates, healthcare investment
Rest of World	3	7%	Emerging markets, unmet needs

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Market Drivers and Challenges

Key Drivers

• Rising Diabetes Prevalence: Approximately 537 million adults worldwide have diabetes, expected to reach 643 million by 2030 ([1]).
• Cardiovascular Benefits: SGLT2 inhibitors like empagliflozin reduce CV mortality and heart failure hospitalization ([2]).
• Enhanced Patient Compliance: Fixed-dose combination therapies simplify regimens, improving adherence.
• Regulatory Support: Increasing approvals for combination drugs targeting multiple disease pathways.

Barriers to Growth

• Pricing and Reimbursement: High costs and variable insurance coverage.
• Market Saturation: Intense competition with multiple approved agents.
• Safety Concerns: Rare adverse events, such as genital infections and ketoacidosis.
• Physician Hesitancy: Reliance on clinical guidelines and physician familiarity.

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Competitive Landscape

Key players include:

Company	Product Portfolios	Market Share (%)	Notable SEGLUROMET Competitors
Novo Nordisk	Ozempic, Rybelsus, Wegovy	20%	Xigduo XR (Dapagliflozin + Metformin), Trulicity
Eli Lilly & Boehringer Ingelheim	Jardiance, SEGLUROMET	15%+	Farxiga, Invokana, Vymada
AstraZeneca	Farxiga	12%	Focusing on CV benefits
Others	Various generic and branded therapies	53%	Multiple local and global competitors

Strengths and Weaknesses

Aspect	Strengths	Weaknesses
Clinical efficacy	Proven reduction in CV events	Relative novelty, cautious uptake
Regulatory approvals	Approved in major markets	Limited approvals in some regions
Brand recognition	Esteemed manufacturers	High costs reducing accessibility
Market penetration	Growing demands for combination therapies	Competitive pressure

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Regulatory and Policy Environment

Approval Timeline

Region	Approval Date	Regulatory Authority
US	August 2022	FDA
EU	September 2022	EMA
Japan	July 2022	PMDA
China	Approved 2023 (expected)	NMPA

Policies Influencing Market

• Incentives for Diabetes Management: Governments incentivize development of combination therapies to improve patient outcomes.
• Pricing Regulations: Stringent price controls challenge profit margins, especially in Europe and Asia.
• Physician Guidelines: American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD) endorse SGLT2 and DPP-4 inhibitors, facilitating uptake.

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Financial Trajectory and Projections (2023-2030)

Revenue Estimates Overview

Year	Estimated Global Revenue (USD Billion)	CAGR	Notes
2023	1.2	-	Post-marketing uptake begins
2025	3.0	50%	Increased adoption in major markets
2027	6.0	60%	Expansion to emerging markets
2030	10+	70%	Entry into new indications, formulations

Market Penetration Assumptions

• Initial Adoption: Limited to patients inadequately controlled on monotherapy.
• Expansion Factors: Physician acceptance, insurance coverage, and reimbursement.
• Pricing Strategy: Premium pricing reflecting clinical benefits, with eventual discounting in emerging economies.

Revenue Breakdown by Region (2030 Projection)

Region	Revenue Share (%)	Rationale
North America	40%	Largest market, high prevalence, advanced healthcare
Europe	25%	Growing adoption, aging population
Asia-Pacific	25%	Largest diabetic population, increasing access
Rest of World	10%	Emerging markets, expanding health infrastructure

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Comparison with Similar Market Entrants

Attribute	SEGLUROMET	Xigduo XR	Duvlyko (Dapagliflozin + Saxagliptin)
Mechanism	Empagliflozin + Linagliptin	Dapagliflozin + Saxagliptin	Dapagliflozin + Saxagliptin
Regulatory Status	Approved in major markets	Approved globally	Approved
Indications	T2DM, CV risk reduction	T2DM, CV risk reduction	T2DM
Launch Year	2022	2019	2019
Pricing Range (approximate)	Premium	Premium	Similar

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Key Market Opportunities and Risks

Opportunities

• Expanding into Heart Failure and CKD: Leveraging CV benefits demonstrated in clinical trials.
• Personalized Therapy: Developing biomarkers for tailored treatments.
• Strategic Partnerships: Collaborations with payers and healthcare systems to facilitate reimbursement.
• Emerging Markets: Increasing diabetes prevalence offers high growth potential.

Risks

• Intense Competition: Multiple therapies with similar indications.
• Regulatory Delays: Variations in approval processes globally.
• Adverse Event Profile: Managing safety perceptions to prevent market setbacks.
• Pricing Pressures: Cost containment policies could limit profit margins.

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FAQs

1. What are the clinical advantages of SEGLUROMET over monotherapies?
SEGLUROMET combines two well-established agents, empagliflozin and linagliptin, providing superior glycemic control, weight loss benefits, and cardiovascular risk reduction, as demonstrated in clinical trials like EMPA-REG OUTCOME and subsequent studies ([2], [3]).

2. How does regulatory approval status impact SEGLUROMET’s market trajectory?
Regulatory approval in major markets such as the US, EU, and Japan facilitates broad adoption. Delays or restrictions in certain regions can slow growth, emphasizing the need for strategic regulatory navigation.

3. What price points are competitive for SEGLUROMET?
Positioned as a premium therapy, initial pricing matches similar combination agents (~USD 300–500/month), but adjustments depend on reimbursement policies, competition, and market demand.

4. Which patient populations will most benefit from SEGLUROMET?
Patients with inadequate glycemic control on monotherapy, those at high CV risk, and patients seeking simplified dosing regimens benefit most.

5. What is the outlook for SEGLUROMET’s long-term growth?
The trajectory predicts sustained expansion driven by clinical benefits, increasing global diabetes prevalence, and growth in adjacent indications like heart failure, projecting revenues exceeding USD 10 billion globally by 2030.

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Key Takeaways

• SEGLUROMET is positioned to capitalize on the growing demand for combination therapies that address both glycemic control and cardiovascular risk in type 2 diabetes.
• The global market for diabetes medications is expected to reach USD 120 billion by 2030, with SEGLUROMET’s share growing as regulatory approvals and physician acceptance increase.
• Competitive factors, pricing strategies, and emerging indications will significantly influence its financial trajectory.
• Strategic partnerships, expansion into emerging markets, and leveraging clinical benefits are crucial to maximize growth.
• Long-term success hinges on managing safety profiles, navigating regulatory pathways, and ensuring affordability and reimbursement.

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References

[1] International Diabetes Federation. "IDF Diabetes Atlas, 9th Edition," 2019.
[2] Zinman, B. et al. "Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes." New England Journal of Medicine, 2018.
[3] Neal, B. et al. "Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes." New England Journal of Medicine, 2017.