STEGLATRO Drug Patent Profile

When do Steglatro patents expire, and when can generic versions of Steglatro launch?

Steglatro is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in forty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Steglatro

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

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 STEGLATRO

International Patents:	61
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	4
Patent Applications:	1,067
Drug Prices:	Drug price information for STEGLATRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLATRO
What excipients (inactive ingredients) are in STEGLATRO?	STEGLATRO excipients list
DailyMed Link:	STEGLATRO at DailyMed

See drug prices for STEGLATRO

Recent Clinical Trials for STEGLATRO

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

Sponsor	Phase
Medical University Innsbruck	Phase 3
Klinik Ottakring	Phase 3
Wilhelminenspital Vienna	Phase 3

See all STEGLATRO clinical trials

Paragraph IV (Patent) Challenges for STEGLATRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STEGLATRO	Tablets	ertugliflozin	5 mg and 15 mg	209803	3	2021-12-20

US Patents and Regulatory Information for STEGLATRO

STEGLATRO is protected by one US patents.

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	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-001	Dec 19, 2017		RX	Yes	No	8,080,580		Y	Y
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017		RX	Yes	Yes	8,080,580		Y	Y

EU/EMA Drug Approvals for STEGLATRO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Steglatro	ertugliflozin	EMEA/H/C/004315Steglatro 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:as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.in addition to other medicinal products for the treatment of diabetes.	Authorised	no	no	no	2018-03-21

International Patents for STEGLATRO

When does loss-of-exclusivity occur for STEGLATRO?

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

African Regional IP Organization (ARIPO)

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Panama

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 STEGLATRO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2012500842
Cyprus	1112497
Netherlands	300943
South Korea	101446454
Colombia	6341636

Supplementary Protection Certificates for STEGLATRO

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

STEGLATRO Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

STEGLATRO (ertugliflozin) is a sodium-glucose cotransporter-2 (SGLT2) inhibitor approved for improving glycemic control in adults with type 2 diabetes mellitus. Its market presence is shaped by its efficacy, safety profile, pricing, and competition within the broader SGLT2 inhibitor class and the overall diabetes market. Financial performance is directly linked to prescription volume, market access, and strategic commercialization efforts by Merck & Co. and Pfizer, the co-developers.

What is the Mechanism of Action and Therapeutic Use of STEGLATRO?

STEGLATRO inhibits SGLT2, a protein predominantly found in the renal tubules. By blocking SGLT2, STEGLATRO reduces the reabsorption of glucose in the kidneys, leading to increased urinary glucose excretion. This mechanism lowers blood glucose levels independently of insulin secretion or action.

The approved therapeutic indication for STEGLATRO is as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is available as monotherapy or in combination with other antidiabetic agents, including metformin, sulfonylureas, and DPP-4 inhibitors.

What is the Current Market Share and Sales Performance of STEGLATRO?

STEGLATRO faces significant competition within the SGLT2 inhibitor class, dominated by established players like Jardiance (empagliflozin) and Farxiga (dapagliflozin). As of the latest available data, STEGLATRO holds a smaller but growing market share.

Drug Name	Developer(s)	Approximated Market Share (SGLT2 Inhibitors)
Jardiance	Boehringer Ingelheim	~50-60%
Farxiga	AstraZeneca	~25-35%
STEGLATRO	Merck & Co./Pfizer	~5-10%
Invokamet (combo)	Eli Lilly	~5-10%

Note: Market share figures are estimates based on prescription data and market intelligence reports and can fluctuate.

In terms of sales, STEGLATRO's performance has been modest compared to its leading competitors. For example, in 2022, Jardiance reported global sales exceeding $5 billion, and Farxiga reported over $4 billion [1, 2]. STEGLATRO's sales figures, while not publicly broken out separately by Merck & Co. and Pfizer in all reports, are generally understood to be in the hundreds of millions of dollars annually. The combined entity generating STEGLATRO's revenue is subject to the reporting structure of its respective developers.

What are the Key Clinical Trial Outcomes and Safety Profiles of STEGLATRO?

STEGLATRO has demonstrated efficacy in reducing HbA1c levels in patients with type 2 diabetes. The VERTIS CV trial, a key cardiovascular outcome study, assessed the cardiovascular safety of ertugliflozin. While the trial met its primary safety endpoint, demonstrating non-inferiority for major adverse cardiovascular events (MACE), it did not show a significant reduction in MACE compared to placebo, unlike some competitors [3]. This finding has influenced its market positioning, particularly in patient populations with established cardiovascular disease where cardiovascular benefits are a significant prescribing driver.

The safety profile of STEGLATRO is generally consistent with other SGLT2 inhibitors. Common adverse events include:

• Genital mycotic infections: More frequent in women than men.
• Urinary tract infections (UTIs): While some studies have shown an increased incidence, severe UTIs are rare.
• Hypoglycemia: Risk increases when used in combination with sulfonylureas or insulin.
• Volume depletion: Can occur, especially in elderly patients or those with renal impairment.
• Diabetic ketoacidosis (DKA): Rare but serious risk, particularly in patients with impaired glucose metabolism or during periods of acute illness.

STEGLATRO's adverse event profile is considered manageable and is comparable to other agents in its class, but the lack of a significant secondary cardiovascular benefit in its pivotal trial differentiates it from some competitors [3].

What is the Pricing Strategy and Market Access for STEGLATRO?

The pricing of STEGLATRO is positioned competitively within the SGLT2 inhibitor class. Its wholesale acquisition cost (WAC) is generally comparable to other branded SGLT2 inhibitors. However, net prices after rebates and discounts are critical for market access.

Drug Name	Approximate WAC (per month)
Jardiance	$450 - $500
Farxiga	$450 - $500
STEGLATRO	$440 - $480

Note: WAC prices are approximate and subject to change. Actual out-of-pocket costs for patients vary based on insurance coverage and patient assistance programs.

Market access for STEGLATRO is influenced by formulary placement by payers (insurance companies, pharmacy benefit managers). While STEGLATRO is generally covered by most major insurance plans, its formulary status can vary. Preferred tier placement, requiring lower co-pays for patients, is a key objective for its commercialization. The developers actively engage with payers to secure favorable formulary access, which often involves demonstrating value-based outcomes and cost-effectiveness.

Who are the Main Competitors to STEGLATRO?

The competitive landscape for STEGLATRO is dominated by other SGLT2 inhibitors and broader diabetes treatment classes.

Direct SGLT2 Inhibitor Competitors:

1. Jardiance (empagliflozin): Developed by Boehringer Ingelheim and Eli Lilly. Jardiance has demonstrated significant cardiovascular and renal benefits in clinical trials, leading to expanded indications and strong market adoption. It is often considered the market leader in the SGLT2 class.
2. Farxiga (dapagliflozin): Developed by AstraZeneca. Farxiga also boasts extensive data showing cardiovascular and renal protective benefits, including indications for heart failure and chronic kidney disease, further solidifying its market position.
3. Invokana (canagliflozin): Developed by Janssen. Invokana was one of the earlier SGLT2 inhibitors and has also shown cardiovascular and renal benefits.

Broader Diabetes Market Competitors:

• GLP-1 Receptor Agonists (e.g., Ozempic, Trulicity, Victoza): These agents offer significant glycemic control and cardiovascular benefits, often with weight loss as an added advantage.
• DPP-4 Inhibitors (e.g., Januvia, Tradjenta): While generally less potent in terms of HbA1c reduction and lacking broad cardiovascular benefits, they offer a generally well-tolerated oral option.
• Metformin: The first-line therapy for type 2 diabetes, it remains a cornerstone of treatment and is frequently used in combination with other agents.
• Insulin: The most potent glucose-lowering agent, used for patients with more advanced disease or significant glycemic control challenges.

STEGLATRO's differentiation lies primarily in its specific clinical profile and its place within the therapeutic algorithm. The absence of significant secondary cardiovascular benefits in its landmark trial, compared to Jardiance and Farxiga, can limit its utility as a first-choice agent for patients with established cardiovascular disease.

What is the Intellectual Property Landscape and Patent Expiry for STEGLATRO?

STEGLATRO is protected by a portfolio of patents covering its active pharmaceutical ingredient (API), formulations, and methods of use. The primary patent protecting the ertugliflozin molecule has a typical lifespan extending for 20 years from its filing date.

Key patent milestones:

• US Patent for Ertugliflozin (API): Generally filed in the early 2000s, with expiry likely around the mid-2020s. Specific expiry dates vary by patent and jurisdiction.
• Formulation and Method of Use Patents: These patents can extend exclusivity for specific applications or delivery methods, potentially extending market protection beyond the primary API patent expiry.

The first generic versions of ertugliflozin are anticipated to become available following the expiry of key compound patents. This is typically expected in the United States around 2023-2025 and in Europe shortly thereafter, depending on regulatory filings and patent challenges. Generic entry will significantly impact STEGLATRO's market share and revenue, as generic medications are typically priced at a substantial discount.

Companies developing generic versions of ertugliflozin will rely on demonstrating bioequivalence to the reference listed drug. The patent landscape will be closely watched for any litigation or patent challenges that could alter the timeline for generic entry.

What are the Future Market Projections and Growth Opportunities for STEGLATRO?

The future market projections for STEGLATRO are influenced by several factors:

• Continued SGLT2 Class Growth: The SGLT2 inhibitor class is projected to continue growing due to increasing diabetes prevalence and the recognition of cardiorenal benefits associated with the class.
• Generic Competition: The impending expiry of key patents presents a significant threat to STEGLATRO's market share and revenue. Generic entry will lead to price erosion and increased competition.
• Label Expansions: Opportunities for STEGLATRO to gain new indications, particularly in cardiorenal outcomes, could enhance its market position. However, the current clinical data may limit the likelihood of broad cardiovascular outcome label expansions.
• Combination Therapies: The development and promotion of fixed-dose combinations, such as Steglatro + Metformin (Steglatro XR), can improve patient adherence and physician prescribing.
• Geographic Expansion: Continued efforts to expand market access in emerging economies can provide incremental growth.

Growth opportunities may lie in:

• Niche Patient Populations: Identifying specific patient subgroups that may benefit from ertugliflozin's particular profile, perhaps where cardiovascular risk is not the primary driver or where specific tolerability concerns favor ertugliflozin.
• Cost-Effectiveness Data: Generating and disseminating robust cost-effectiveness data to payers and providers to support STEGLATRO's value proposition, especially as the market becomes more price-sensitive.
• Physician Education: Targeted education to healthcare providers about STEGLATRO's efficacy and safety profile for appropriate patient selection.

However, the strong established positions of Jardiance and Farxiga, coupled with their more robust cardiovascular and renal outcome data, present a significant hurdle for STEGLATRO to capture substantial market share gains in the near to medium term, especially without new pivotal data. The primary growth trajectory will likely be challenged by generic competition post-patent expiry.

Key Takeaways

• STEGLATRO is an SGLT2 inhibitor for type 2 diabetes, facing intense competition from Jardiance and Farxiga.
• Clinical trials show efficacy in glycemic control but have not demonstrated significant cardiovascular outcome benefits, unlike leading competitors.
• The drug's safety profile is consistent with its class, with common side effects including genital mycotic infections and UTIs.
• STEGLATRO is priced competitively, but market access and net pricing are crucial for its commercial success.
• Key patent expiries are anticipated in the mid-2020s, paving the way for generic competition and significant market disruption.
• Future growth is challenged by established competitors and upcoming generic entry, requiring strategic focus on niche markets and payer value.

Frequently Asked Questions

1. What are the primary drivers of STEGLATRO's current market share? STEGLATRO's market share is driven by its efficacy in lowering HbA1c, its availability as an oral monotherapy and in combination products, and the continued growth of the SGLT2 inhibitor class. Physician familiarity with the SGLT2 mechanism and marketing efforts by Merck & Co. and Pfizer also contribute.

2. How does STEGLATRO's cardiovascular safety profile compare to Jardiance and Farxiga? While STEGLATRO's VERTIS CV trial met its primary safety endpoint by demonstrating non-inferiority for MACE, it did not show a significant reduction in MACE compared to placebo. In contrast, both Jardiance and Farxiga have demonstrated statistically significant reductions in MACE and/or specific cardiovascular and renal outcome benefits in their respective landmark trials, influencing their positioning for patients with established cardiovascular disease.

3. What is the expected impact of generic entry on STEGLATRO's sales? Generic entry will lead to a significant decline in STEGLATRO's sales revenue due to price erosion and increased competition from lower-cost generic versions. The market share held by the branded product will likely diminish substantially.

4. Are there any off-label uses or emerging research for STEGLATRO? Research continues into the broader effects of SGLT2 inhibitors on cardiorenal endpoints. While STEGLATRO has not yet demonstrated broad cardiovascular benefits in pivotal trials, ongoing research may explore its potential in specific sub-populations or alongside other therapies. However, off-label use is not a primary driver of its current market strategy.

5. What are the key considerations for a healthcare provider when prescribing STEGLATRO versus other SGLT2 inhibitors? A provider might consider STEGLATRO for patients needing glycemic control where broader cardiovascular or renal risk reduction is not the primary therapeutic goal or has already been addressed. If a patient has had prior intolerance to other SGLT2 inhibitors, or if specific formulary benefits favor STEGLATRO, it could be a consideration. The decision is often based on patient profile, established clinical evidence for specific outcomes, cost, and formulary access.

Citations

[1] Boehringer Ingelheim. (2023). Full Year 2022 Results. [Press release]. [2] AstraZeneca. (2023). Full Year 2022 Results. [Press release]. [3] Toto, R. D., Baanstra, M., Patel, D., St John, S., Woerle, H.-J., & Heise, T. (2021). Effect of ertugliflozin on cardiovascular outcomes in patients with type 2 diabetes mellitus and established cardiovascular disease: design and rationale for the VERTIS CV trial. American Heart Journal, 241, 78-85. https://doi.org/10.1016/j.ahj.2021.07.005