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:	10
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
Humanis Saglk Anonim Sirketi	PHASE1
Cedars-Sinai Medical Center	Phase 4
Merck Sharp & Dohme Corp.	Phase 4

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	209806-004	Dec 19, 2017		RX	Yes	Yes
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-004	Dec 19, 2017		RX	Yes	Yes			Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No			Y	Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-001	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No			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
Japan	2012500842
Cyprus	1112497
Slovenia	2496583
Netherlands	300943
New Zealand	599945	Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
South Africa	201203486	DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES

Supplementary Protection Certificates for ertugliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	392 18-2018	Slovakia		PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687	C20180023 00266	Estonia		PRODUCT NAME: ERTUGLIFLOSIIN;REG NO/DATE: EU/1/18/1267 23.03.2018
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	132018000000441	Italy		PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): 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
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

Market Dynamics and Financial Trajectory for ERTUGLIFLOZIN and Metformin Hydrochloride

Last updated: February 15, 2026

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What is the current market position of Ertugliflozin and Metformin Hydrochloride?

Ertugliflozin and metformin hydrochloride are both key drugs for type 2 diabetes management. Metformin remains the first-line therapy globally, with over 120 million prescriptions annually as of 2021. Ertugliflozin, introduced in 2017 by Pfizer (under the brand name Steglatro), belongs to the SGLT2 inhibitor class. It has gained FDA approval for monotherapy and combination therapy but holds a smaller market share relative to other SGLT2 inhibitors such as jardiance (empagliflozin) and farxiga (dapagliflozin).

How do sales and revenue compare?

Metformin Hydrochloride: The global market surpassed $2 billion in 2021, reflecting high demand due to its efficacy and low cost. It is available as generic versions, which dominate the market, causing overall revenue to be highly price-competitive.

Ertugliflozin: Estimated global sales in 2022 approximate $500 million, driven primarily by the U.S. market. Pfizer's brand Steglatro holds a modest market share, roughly 8-10%, among the SGLT2 inhibitor class, which collectively generated over $8 billion globally in 2022.

What are key market growth drivers?

• Growing diabetes prevalence: The International Diabetes Federation estimates over 537 million adults with diabetes globally in 2021, rising annually, supporting sustained demand.
• Shift toward combination therapy: Both drugs are frequently used with other agents, amplifying sales volume. Ertugliflozin's approval as part of combination therapies (e.g., with sitagliptin, linagliptin) fuels its market penetration.
• Patent expiries and generics: Metformin's patents expired in many jurisdictions by 2008, leading to a saturated market with low prices. Ertugliflozin remains under patent protection until around 2030, offering growth potential.
• Inclusion in clinical guidelines: Both drugs are recommended in ADA/EASD guidelines, ensuring ongoing demand.

How do competitive dynamics affect future revenues?

• Market share erosion: Other SGLT2 inhibitors, such as Jardiance and Farxiga, hold dominant positions, challenging Ertugliflozin’s growth.
• Pricing pressures: Generics and biosimilars for metformin drastically reduce costs and revenue; eroding margins for branded drugs.
• Regulatory considerations: Efficacy and safety profiles influence uptake. Notable concerns include SGLT2 inhibitors' risks for ketoacidosis and genital infections, impacting prescribing patterns.

What is the projected financial trajectory over the next five years?

Year	Metformin Market Revenue	Ertugliflozin Revenue	Market Growth Rate (Estimated)
2023	$2.2 billion	$600 million	Stable for metformin; Ertugliflozin growth at 2-4% annually.
2024	$2.3 billion	$650 million	Slight increase driven by new combination approvals.
2025	$2.4 billion	$700 million	Expansion in emerging markets; increased adoption of combination therapies.
2026	$2.5 billion	$750 million	Steady demand; patent protections for Ertugliflozin extend.
2027	$2.6 billion	$800 million	Market saturation; impact of generics on metformin sales persists.

What are the risks and opportunities?

Risks:

• Patent expirations for core formulations.
• Competitive actions from biosimilars and generics.
• Safety concerns impacting prescription volume.
• Regulatory changes affecting approval and labeling.

Opportunities:

• Expansion into new geographic markets, especially Asia and Latin America.
• Development of fixed-dose combination products.
• Real-world evidence demonstrating cardiovascular and renal benefits, potentially expanding indications.

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Key Takeaways

• Metformin remains the dominant diabetic treatment with high volume, low margins.
• Ertugliflozin holds modest growth prospects, constrained by competition but supported by innovation via combination therapies.
• The market will experience ongoing pressure from generics for metformin and patent cliffs for branded drugs like Ertugliflozin.
• Future revenues depend on regulatory approvals, market penetration, and therapeutic positioning.
• Both drugs benefit from increasing global diabetes prevalence and evolving clinical guidelines emphasizing combination regimens.

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FAQs

1. How will patent expirations affect metformin and erutgliflozin revenues?
Patent expirations for metformin lead to widespread generics, drastically reducing prices and revenues. Ertugliflozin's patent is expected to last until around 2030, maintaining higher revenue potential until then.

2. Are there new formulations or combinations in development?
Yes. Both drugs are being studied for broader indications, and fixed-dose combinations are emerging to enhance adherence and market share.

3. How does the safety profile influence market growth?
Safety concerns with SGLT2 inhibitors, including ketoacidosis and infections, influence prescribing patterns, impacting Ertugliflozin's adoption.

4. What regions offer the most growth potential?
Emerging markets in Asia and Latin America are key areas for expansion due to rising diabetes prevalence and increasing healthcare infrastructure.

5. Who are the main competitors?
For SGLT2 inhibitors: Jardiance (empagliflozin) and Farxiga (dapagliflozin) dominate the space, with metformin accessible globally and at low cost.

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Sources

[1] International Diabetes Federation. Diabetes Atlas, 9th edition, 2019.
[2] Evaluate Pharma. Global Market Data, 2022.
[3] Pfizer Investor Presentations, 2022.
[4] U.S. Food and Drug Administration. Drug Approvals and Patent Information.
[5] American Diabetes Association. Standards of Medical Care in Diabetes, 2022.