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
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.

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
Croatia	P20120104
Georgia, Republic of	P20146104	DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Costa Rica	20110077
Portugal	2496583
Cuba	24003

Supplementary Protection Certificates for SEGLUROMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2018510,C2334687	Lithuania		PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687	LUC00079	Luxembourg		PRODUCT NAME: ERTUGLIFLOZINE, EVENTUELLEMENT SOUS FORME CRISTALLINE, EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTAMIQUE, ET PLUS SPECIFIQUEMENT EN TANT QU'ACIDE ERTUGLIFLOZINE L-PYROGLUTAMIQUE; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 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	C02334687/01	Switzerland		FORMER OWNER: PFIZER INC., US

Market Dynamics and Financial Trajectory for SEGLUROMET

Last updated: July 28, 2025

Introduction

SEGLUROMET, a combination oral antidiabetic medication, has emerged as a significant player within the evolving landscape of type 2 diabetes management. Developed through collaborations between Merck & Co. and AstraZeneca, SEGLUROMET combines two active ingredients—ertugliflozin (an SGLT2 inhibitor) and metformin (a longstanding first-line therapy)—to capitalize on complementary mechanisms of action. This article explores the current market dynamics, growth prospects, competitive landscape, and financial trajectory forecast for SEGLUROMET.

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Market Overview and Demand Drivers

Type 2 diabetes remains a global health challenge, with estimates indicating over 537 million adults affected worldwide as of 2021, projected to reach 643 million by 2030.[1] The rising prevalence, coupled with increased awareness and evolving treatment guidelines, fuels demand for effective therapies. The landscape shifts towards combination therapies, necessitated by disease complexity and comorbidities such as obesity, cardiovascular disease, and kidney impairment.

SEGLUROMET targets a segment of this market—patients inadequately controlled on monotherapy who require multi-mechanistic approaches. Its approval in multiple regions, including the U.S. and Europe, correlates with growing clinician adoption for early combination therapy, consistent with recent guidelines advocating a more aggressive treatment for higher-risk patients.[2]

Key demand drivers include:

• Adherence through fixed-dose combinations: Simplifies medication regimens, improving patient compliance.
• Comorbidity management: SGLT2 inhibitors like ertugliflozin confer cardiovascular and renal benefits, aligning with holistic diabetes care.
• Pricing and reimbursement: Favorable health-economic evaluations influence formulary placements, vital for market penetration.

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Competitive Landscape

SEGLUROMET faces competition from established single-agent therapies as well as newer combination formulations. Prominent competitors include:

• Jardiance (empagliflozin/metformin combination): Marketed by Boehringer Ingelheim and Eli Lilly, Jardiance is a significant rival given its early market entry and extensive clinical data on cardiovascular outcomes.[3]
• Xigduo XR (dapagliflozin/metformin): Produced by AstraZeneca, with a comparable mechanism and similar positioning.
• Synjardy (empagliflozin/metformin): BMS and AstraZeneca collaboration, noted for strong market penetration.

Emerging competitors include novel fixed-dose combinations and biosimilars. However, SEGLUROMET can leverage its unique clinical profile and positioning within Merck’s portfolio, emphasizing its favorable efficacy and safety profile observed in pivotal trials.[4]

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Regulatory and Pharmacoeconomic Factors

Regulatory agencies like the U.S. FDA and EMA have approved SEGLUROMET based on robust clinical trial data demonstrating non-inferiority or superiority in glycemic control, with added benefits in weight reduction and blood pressure.[5] These endorsements facilitate payer acceptance and reimbursement, crucial for financial sustainability.

Pharmacoeconomic analyses consistently highlight the cost-effectiveness of combination therapies—including SEGLUROMET—by reducing long-term complications and hospitalizations related to cardiovascular and kidney events.[6] Such evaluations underpin formulary inclusion and influence prescribing patterns.

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Growth and Revenue Projections

Current estimates project the global market for SGLT2 and metformin-based combination therapies to reach approximately $10 billion by 2025, with a compounded annual growth rate (CAGR) of 8-12%. SEGLUROMET's market share, while initially modest, is expected to accelerate with increased clinician awareness and expanded indications.

Factors influencing revenue trajectory include:

• Market Penetration and Adoption: As prescribers increasingly leverage early combination therapy, SEGLUROMET's uptake should rise, particularly in North America and Europe.
• Geographical Expansion: Entry into emerging markets, such as Asia-Pacific, can significantly boost revenues given rising diabetes prevalence.
• Pricing Strategies: Competitive pricing, aligned with reimbursement frameworks, will influence volume sales.
• Pipeline Development: Additional clinical data, potential new indications (e.g., for weight management), and innovative formulations can extend lifecycle revenues.

Analyzing existing competitive products suggests that, assuming a conservative market share of 5-8%, SEGLUROMET could generate annual revenues in the range of $300 million to $600 million within the next 3-5 years, with potential upside driven by market expansion.

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Key Challenges and Risks

• Generic Competition: The patent landscape for metformin and SGLT2 inhibitors faces erosion, risking biosimilar entry and pricing pressures.
• Regulatory Hurdles: Stricter approval standards and post-marketing requirements could delay approvals or limit indications.
• Market Saturation: The proliferation of similarly positioned therapies may cap growth.
• Clinical Uncertainties: Future data on long-term safety, especially regarding rare adverse events, could influence adoption.

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Strategic Opportunities

To optimize financial trajectory, stakeholders should consider:

• Expanding indications: For example, exploring benefits in heart failure or chronic kidney disease to broaden market appeal.
• Enhancing clinical trial data: Demonstrating superiority or additional benefits can differentiate SEGLUROMET.
• Strengthening payer relationships: Integrating pharmacoeconomic advantages into formulary negotiations.
• Innovating delivery formats: Developing once-daily formulations or fixed-dose combinations with added therapies to capture niche markets.

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Conclusion

SEGLUROMET stands at the nexus of a rapidly expanding diabetic therapy market, driven by increasing global prevalence and a shift towards combination regimens. While competitive pressures and patent expirations pose challenges, its clinical positioning, regulatory support, and health economic viability underpin a promising growth trajectory. Careful strategic execution focusing on market expansion, data-driven differentiation, and value-based pricing can facilitate its journey toward becoming a substantial contributor to Merck and AstraZeneca’s diabetes portfolios.

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Key Takeaways

• The global diabetes therapeutics market, especially fixed-dose SGLT2/metformin combinations like SEGLUROMET, is poised for substantial growth driven by rising disease prevalence and evolving treatment paradigms.
• Clinical advantages such as cardiovascular and renal benefits position SEGLUROMET favorably, enabling its adoption in comprehensive diabetes management.
• Competitive landscape demands differentiation through clinical data, pricing, and expanded indications to secure market share.
• Regulatory approval and reimbursement strategies are crucial for accelerating uptake and ensuring sustainable revenue streams.
• Investment in pipeline development and strategic market expansion will be critical for maximizing the financial trajectory of SEGLUROMET.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.
[2] American Diabetes Association. Standards of Medical Care in Diabetes—2023.
[3] Boehringer Ingelheim. Jardiance (empagliflozin) label.
[4] Clinical trial data on ertugliflozin/metformin combination.
[5] FDA Approval Documents for SEGLUROMET.
[6] Pharmacoeconomic evaluations of SGLT2 inhibitors in diabetes management.