Ertugliflozin; metformin hydrochloride - Generic Drug Details

What are the generic sources for ertugliflozin; metformin hydrochloride and what is the scope of freedom to operate?

Ertugliflozin; metformin hydrochloride is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin; metformin hydrochloride has eighty-seven patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for ertugliflozin; metformin hydrochloride

International Patents:	87
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ertugliflozin; metformin hydrochloride
DailyMed Link:	ertugliflozin; metformin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ertugliflozin; metformin hydrochloride

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 ertugliflozin; metformin hydrochloride

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 4
Cedars-Sinai Medical Center	Phase 4
Merck Sharp & Dohme Corp.	Phase 3

See all ertugliflozin; metformin hydrochloride clinical trials

Pharmacology for ertugliflozin; metformin hydrochloride

Drug Class

Biguanide

Anatomical Therapeutic Chemical (ATC) Classes for ertugliflozin; 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

US Patents and Regulatory Information for ertugliflozin; metformin hydrochloride

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	209806-001	Dec 19, 2017		RX	Yes	No			Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No			Y	Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-004	Dec 19, 2017		RX	Yes	Yes			Y

EU/EMA Drug Approvals for ertugliflozin; metformin hydrochloride

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 ertugliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Lithuania	C2334687
Montenegro	02016	DERIVATI DIOKSABICIKLO[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Japan	4825322

Supplementary Protection Certificates for ertugliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	CA 2018 00025	Denmark		PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323
2334687	300943	Netherlands		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, MET NAME ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687	C201830047	Spain		PRODUCT NAME: ERTUGLIFLOZINA, OPICIONALMENTE EN FORMA CRISTALINA, PARTICULARMENTE COMO UN CO-CRISTAL CON ACIDO L-PIROGLUTAMICO, Y ESPECIFICAMENTE COMO ACIDO L-PIROGLUTAMICO DE ERTUGLIFLOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1267; DATE OF AUTHORISATION: 20180321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1267; DATE OF FIRST AUTHORISATION IN EEA: 20180321

Market Dynamics and Financial Trajectory of Ertugliflozin and Metformin Hydrochloride

Last updated: July 29, 2025

Introduction

The global pharmaceutical landscape for diabetes management continues to evolve, driven by technological advances, regulatory shifts, and demographic changes. Among the prominent classes of antidiabetic agents, Ertugliflozin—a sodium-glucose co-transporter 2 (SGLT2) inhibitor—and Metformin Hydrochloride—an enduring first-line therapy—stand out for their clinical efficacy and market significance. This analysis explores the market dynamics and financial trajectories of these two agents, emphasizing their roles, competitive positioning, pricing strategies, and future outlook within the expanding diabetes pharmaceutical segment.

Ertugliflozin: Market Dynamics and Financial Outlook

Product Overview and Clinical Positioning

Ertugliflozin, marketed globally as Steglatro by Pfizer, is an SGLT2 inhibitor indicated as an adjunct to diet and exercise for type 2 diabetes mellitus (T2DM) management. Since its FDA approval in 2017, Ertugliflozin has positioned itself within a competitive class that includes drugs like canagliflozin, dapagliflozin, and empagliflozin. Its mechanism involves promoting urinary glucose excretion, thereby reducing blood glucose levels.

Market Drivers

The expanding T2DM patient base is a fundamental driver for Ertugliflozin. The International Diabetes Federation estimates over 530 million adults globally suffer from diabetes—a figure projected to rise as obesity and sedentary lifestyles increase worldwide [1]. The trend towards combination therapies further boosts demand, with Ertugliflozin often prescribed alongside metformin or other antihyperglycemics.

Regulatory approvals in multiple regions, including Japan and Europe, bolster its market penetration. Additionally, the drug’s cardiovascular and renal benefits—demonstrated in trials like VERTIS CV—enhance its clinical appeal, aligning with the movement toward cardio-renal protective agents in diabetes care.

Competition and Market Share

The SGLT2 inhibitor class is highly competitive. Dapagliflozin (Farxiga), empagliflozin (Jardiance), and canagliflozin (Invokana) dominate market share, each with extensive real-world evidence and broad geographic approval. Ertugliflozin’s entry has faced challenges in capturing substantial market share, due in part to brand loyalty and existing clinical familiarity with competitors.

Nonetheless, Pfizer's strategic focus on positioning Ertugliflozin as a cost-effective alternative and its utilization within fixed-dose combinations enhances its market prospects. Notably, the VERTIS trials have provided evidence supporting cardiovascular and renal benefits, adding value over some competitors that lack such data.

Pricing and Reimbursement Strategies

Ertugliflozin’s pricing has been set to compete within the established SGLT2 market, with Pfizer leveraging formulary placements and insurance negotiations. Its availability in fixed-dose combinations with metformin and other drugs amplifies its appeal, potentially improving reimbursement prospects and adherence.

Market access varies globally. In the US, pricing strategies align with payer negotiations and value-based assessments, balancing profitability with accessibility. Pfizer’s investments in clinical evidence and marketing campaigns aim to reinforce its positioning in the diabetes segment.

Financial Trajectory

Since its launch, Ertugliflozin has exhibited steady sales growth, though it remains behind market leaders. Pfizer reported that in 2022, Steglatro contributed approximately $300 million in revenues—an increase of around 15% from the previous year [2]. This growth reflects increasing adoption, expansion into new markets, and an expanding indication portfolio.

Potential upside exists as ongoing cardiovascular and renal outcome studies could enhance its clinical profile, fostering broader use and higher reimbursement levels. However, patent expirations and the risk of biosimilar or generic competition in the future pose challenges.

Future Outlook

Projections indicate that the global SGLT2 inhibitor market will grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next five years, driven by increasing T2DM prevalence and recognition of cardio-renal benefits [3]. Ertugliflozin’s market share is expected to expand modestly, contingent on clinical trial outcomes, regulatory approvals, and strategic marketing.

Pfizer’s focus on expanding indications to include heart failure and chronic kidney disease (CKD) could substantially bolster its revenue streams. Additionally, the increasing payer emphasis on value-based outcomes may support premium pricing if Ertugliflozin demonstrates clear benefits.

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Metformin Hydrochloride: Market Dynamics and Financial Trajectory

Product Overview and Clinical Significance

Metformin hydrochloride is a cornerstone drug in T2DM management, widely regarded as the first-line therapy. It operates by decreasing hepatic glucose production and improving insulin sensitivity. Its long history of safety, efficacy, and affordability has cemented its status globally.

Market Drivers

Metformin’s dominance stems from its affordability, high efficacy, and favorable safety profile. It remains the most prescribed antidiabetic agent globally, with over 120 million prescriptions annually as of recent data [4].

The growing global T2DM prevalence, especially in low- and middle-income countries, sustains demand for high-volume, low-cost therapies like Metformin. Regulatory approvals in developing nations, along with its inclusion in essential medicines lists by WHO, ensure widespread availability.

Manufacturing, Patent Status, and Competition

Metformin is off-patent and manufactured by numerous generics producers, leading to intense price competition. Market fragmentation results in low costs but also thin profit margins for manufacturers. The commoditized nature of metformin diminishes opportunities for premium pricing or differentiation.

Nevertheless, formulations such as extended-release (ER) Metformin have gained preference due to improved gastrointestinal tolerability, facilitating patient adherence. The ER formulations typically carry slight price premiums but still benefit from widespread affordability.

Pricing and Reimbursement

The generics market ensures Metformin’s pricing remains extremely low, often under $0.10 per dose in many regions. This affordability spurs high prescription volumes, making Metformin a cash cow for manufacturers, especially in emerging markets with large diabetic populations.

Reimbursement policies generally favor generics, further cementing its market dominance. However, price sensitivity among payers and governments exerts continued pressure to minimize costs.

Financial Trajectory

The global market for Metformin is valued in excess of $2 billion annually, with steady growth aligned to rising diabetes prevalence. The low-cost, high-volume nature of Metformin yields cumulative revenues that are robust despite narrow margins.

Manufacturers who hold manufacturing rights and supply chains enjoy stable revenue streams. For example, several generic companies report annual sales exceeding $100 million for their Metformin formulations, with profit margins remaining sustainable due to economies of scale.

The market is relatively mature; however, innovations around formulations, such as combination pills with SGLT2 inhibitors or DPP-4 inhibitors, offer incremental revenue opportunities.

Future Trends

Long-term market projections suggest steady demand for Metformin, especially in regions experiencing growth in diabetes cases and limited healthcare budgets. While newer therapies challenge its dominance in high-income countries, its low cost ensures ongoing utilization elsewhere.

Potential risks include the emergence of novel oral agents with superior efficacy or safety profiles, as well as regulatory constraints on formulations to prevent off-label use. Nonetheless, Metformin's role as a primary, affordable treatment remains unchallenged in many markets.

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Integrated Market Outlook for Ertugliflozin and Metformin

The confluence of these two agents reflects broader trends in diabetes care. The rising prominence of combination therapy combining Metformin with agents like Ertugliflozin exemplifies a strategy for personalized, effective management. Pfizer’s Ertugliflozin benefits from the expanding SGLT2 inhibitor market, supported by evidence of added cardiovascular and renal benefits—attributes increasingly valued by clinicians and payers.

Simultaneously, the global penetration of Metformin ensures its foundational role remains intact, offering a baseline from which newer agents can build upon. The interplay between these drugs underscores an evolving market driven by clinical data, regulatory approvals, and reimbursement policies.

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Key Takeaways

• Market Expansion: The SGLT2 inhibitor segment, including Ertugliflozin, is projected to grow at 8-10% CAGR over the next five years, driven by demographic shifts and recognition of cardio-renal benefits.

• Competitive Positioning: Ertugliflozin faces stiff competition but benefits from clinical evidence supporting cardiovascular and renal protections, which could bolster market share via expanded indications.

• Pricing Strategies: Both drugs employ distinct pricing models—Ertugliflozin competes within branded markets through value demonstration, whereas Metformin thrives on low-cost generics and economies of scale.

• Revenue Trajectories: Ertugliflozin’s sales are expected to grow modestly, positioning it as a significant yet not dominant player, whereas Metformin’s global sales remain stable due to its price accessibility and fundamental role.

• Future Opportunities: Expansion of Ertugliflozin into heart failure and CKD markets, alongside formulation innovations for Metformin, present lucrative growth pathways.

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FAQs

1. What is the primary clinical advantage of Ertugliflozin over other SGLT2 inhibitors?
Ertugliflozin offers comparable efficacy with a favorable safety profile and potential cost advantages due to competitive pricing and extensive clinical trial data supporting cardiovascular and renal benefits, which may influence prescribing preferences.

2. How does the patent status of Metformin impact the market?
Since Metformin is off-patent, it is widely manufactured as a generic, leading to intense price competition and ensuring affordability. This limits profit margins for producers but sustains high-volume sales globally.

3. What-regulatory developments could influence Ertugliflozin's market?
Recent and upcoming approvals for expanded indications such as heart failure and CKD could substantially enhance Ertugliflozin’s market size and revenue potential, especially if supported by positive outcomes from ongoing studies.

4. How do pricing strategies differ between Ertugliflozin and Metformin?
Ertugliflozin employs value-based pricing with strategic positioning in branded formulations and combinations, whereas Metformin’s generic nature results in minimal costs, ensuring affordability in markets worldwide.

5. What are the key challenges facing Ertugliflozin’s market growth?
Intense competition within the SGLT2 class, patent expirations, payer reimbursement hurdles, and the need for ongoing clinical evidence to substantiate its added benefits are primary obstacles.

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References

1. [1] International Diabetes Federation. IDF Diabetes Atlas, 9th edition, 2019.
2. [2] Pfizer Inc. Annual Report 2022.
3. [3] MarketsandMarkets. SGLT2 Inhibitors Market by Type and Region, Forecast to 2027.
4. [4] IQVIA. Data on global diabetes medication prescriptions, 2022.