STEGLATRO Drug Patent Profile

When do Steglatro patents expire, and what generic alternatives are available?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLATRO

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			Y	Y
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017		RX	Yes	Yes			Y	Y

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
China	102149717
Ecuador	SP11010854
Hong Kong	1156616
Tunisia	2011000066
Israel	236804

Supplementary Protection Certificates for STEGLATRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	132018000000441	Italy		PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323
2334687	PA2018510	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	C02334687/01	Switzerland		FORMER OWNER: PFIZER INC., US
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	18C1036	France		PRODUCT NAME: ERTUGLIFLOZINE,OPTIONNELLEMENT SOUS FORME CRISTALLINE,EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTANIQUE,ET PARTICULIEREMENT ERTUGLIFOZINE ACIDE L-PYROGLUTANIQUE.; REGISTRATION NO/DATE: EU/1/18/1267 20180323

STEGLATRO (Ertugliflozin) Investment Analysis

Last updated: February 19, 2026

STEGLATRO, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor developed by Merck & Co. and Pfizer Inc., presents an investment opportunity in the growing market for type 2 diabetes (T2D) therapies. Its efficacy in lowering HbA1c, coupled with cardiovascular (CV) and renal benefits demonstrated in clinical trials, positions it as a competitive agent. However, market penetration faces challenges from established SGLT2 inhibitors and evolving treatment guidelines.

What is STEGLATRO's Mechanism of Action and Clinical Efficacy?

STEGLATRO (ertugliflozin) is a selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2) in the kidneys. SGLT2 is responsible for reabsorbing approximately 90% of filtered glucose back into the bloodstream. By inhibiting SGLT2, ertugliflozin reduces glucose reabsorption, leading to increased urinary glucose excretion and a subsequent lowering of blood glucose levels in patients with type 2 diabetes.

Clinical trials have substantiated its efficacy in improving glycemic control. The VERTIS (Vast Empiric Trial Investigating Efficacy and Safety of Ertugliflozin) program, a series of Phase 3 studies, demonstrated that ertugliflozin, as monotherapy and in combination with other antidiabetic agents, achieved statistically significant reductions in HbA1c compared to placebo.

• HbA1c Reduction: In the VERTIS MONO trial, ertugliflozin 15 mg achieved a mean HbA1c reduction of -0.86% from baseline at 26 weeks, compared to -0.04% with placebo (p < 0.001). Ertugliflozin 5 mg resulted in a mean reduction of -0.77% (p < 0.001) [1].
• Dose-Response: Both 5 mg and 15 mg doses demonstrated dose-dependent reductions in HbA1c, fasting plasma glucose, and body weight.
• Combination Therapy: In the VERTIS COMB study, ertugliflozin added to metformin resulted in greater HbA1c reductions compared to placebo plus metformin. The 15 mg dose showed a mean HbA1c reduction of -1.03% versus -0.23% for placebo at 26 weeks [2].

Beyond glycemic control, SGLT2 inhibitors, including ertugliflozin, have shown benefits in reducing the risk of major adverse cardiovascular events (MACE) and slowing the progression of chronic kidney disease (CKD). The VERTIS CV trial specifically evaluated the cardiovascular safety and efficacy of ertugliflozin in patients with T2D and established CV disease. While the primary endpoint of non-inferiority for MACE was met, the trial did not demonstrate superiority in reducing MACE compared to placebo [3]. However, secondary and exploratory analyses suggested potential benefits in specific patient populations and for renal outcomes.

What are the Competitive Landscape and Market Positioning?

The SGLT2 inhibitor market is mature and highly competitive, with several established players. STEGLATRO entered a market populated by drugs like:

• Jardiance (empagliflozin): Developed by Eli Lilly and Boehringer Ingelheim. Jardiance has demonstrated robust CV and renal benefits and holds a significant market share.
• Farxiga (dapagliflozin): Developed by AstraZeneca. Farxiga also possesses strong CV and renal outcome data, leading to expanded indications beyond T2D.
• Invokana (canagliflozin): Developed by Johnson & Johnson. Invokana was one of the first SGLT2 inhibitors approved and has shown benefits in reducing CV events and CKD progression.

STEGLATRO's market positioning is influenced by its efficacy in glycemic control and its established safety profile. However, its ability to differentiate itself relies on real-world evidence for CV and renal benefits that may be more pronounced in specific patient subgroups or when compared directly against competitors in head-to-head trials. The drug's approved indications, which include glycemic control and potential for CV/renal risk reduction, align with the broader class but may not offer a unique clinical advantage that would drive rapid market share gains against established market leaders with extensive outcome data.

The commercial strategy for STEGLATRO, managed by Merck & Co. and Pfizer, involves leveraging their existing diabetes portfolios and sales forces. The partnership aims to capitalize on established physician relationships and patient access programs. However, the marketing message must clearly articulate STEGLATRO's value proposition in a crowded therapeutic landscape.

What are the Regulatory Status and Intellectual Property Protection?

STEGLATRO received regulatory approval from the U.S. Food and Drug Administration (FDA) on December 20, 2017, for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes [4]. It also received European Medicines Agency (EMA) approval in July 2017.

The patent landscape for ertugliflozin is crucial for its long-term commercial viability. Key patents include those covering the composition of matter, synthesis, and methods of use.

• Composition of Matter Patents: These patents typically offer the longest period of exclusivity. For ertugliflozin, these patents are expected to expire in the mid-2020s.
• Method of Use Patents: These patents cover specific therapeutic applications, such as treating type 2 diabetes or reducing cardiovascular risk. These can extend market exclusivity beyond the core compound patents.
• Formulation Patents: Patents protecting specific drug formulations can also provide extended market protection.

The development of generics for SGLT2 inhibitors is a significant consideration. Once primary patents expire, generic manufacturers can enter the market, leading to price erosion and a reduction in market share for the originator drug. Companies actively monitor patent expiry dates and engage in litigation to defend their intellectual property rights. For STEGLATRO, the anticipation of patent expiries will influence investment decisions and the long-term profitability projections.

What are the Financial Performance and Market Projections?

Financial performance for STEGLATRO is reported within Merck & Co.'s and Pfizer's broader diabetes portfolios. Direct revenue attribution for STEGLATRO can be challenging as it is often consolidated with other antidiabetic agents. However, available data provides insights into its market contribution.

In 2023, Merck & Co. reported approximately $396 million in global sales for ertugliflozin (STEGLATRO and its combination with sitagliptin, KEMI [5]). Pfizer's reporting on the partnership's sales has been integrated into Merck's disclosures for the product.

Key Financial Data Points (2023):

• Global Sales (Merck): $396 million [5]
• Sales Growth: Year-over-year growth figures are critical for assessing market momentum. Performance trends will dictate future market penetration.

Market projections for SGLT2 inhibitors generally indicate continued growth, driven by:

• Expanding T2D Population: The global prevalence of type 2 diabetes continues to rise due to aging populations, obesity, and lifestyle factors.
• Cardiovascular and Renal Outcome Data: Growing evidence of the benefits of SGLT2 inhibitors in reducing MACE and slowing CKD progression is expanding their use beyond glycemic control. Regulatory bodies are increasingly approving these drugs for broader indications, including heart failure and CKD, irrespective of diabetes status.
• Emerging Markets: Increased access to healthcare and diabetes management in emerging economies presents significant growth opportunities.

However, projections for STEGLATRO specifically will depend on its ability to gain market share against established competitors and its pricing strategy. Competition from biosimil and generic versions post-patent expiry will also impact future revenue streams. Analysts typically project compound annual growth rates (CAGRs) for the SGLT2 inhibitor class. For STEGLATRO, its individual CAGR will likely be lower than the class average if it struggles to gain incremental market share.

What are the Risks and Opportunities for Investors?

Key Risks:

• Intense Competition: Established SGLT2 inhibitors with strong CV and renal outcome data command significant market share and physician loyalty.
• Patent Expiry and Generic Entry: The approaching expiry of key patents will lead to generic competition, substantial price erosion, and reduced market exclusivity.
• Evolving Treatment Guidelines: Shifting treatment paradigms in diabetes management, such as increased emphasis on incretin-based therapies or novel drug classes, could impact SGLT2 inhibitor utilization.
• Adverse Event Profile: While generally well-tolerated, SGLT2 inhibitors carry risks of genitourinary infections, dehydration, and rare but serious events like euglycemic diabetic ketoacidosis. These safety concerns can influence prescribing patterns.
• Reimbursement and Payer Restrictions: Payer policies and formulary restrictions can limit market access and prescribing volume.

Key Opportunities:

• Broader Indications: If future trials demonstrate significant and differentiated CV or renal benefits, STEGLATRO could secure expanded indications, increasing its patient addressable market. The drug's potential to be used in CKD patients independent of diabetes status is a significant opportunity for the SGLT2 class.
• Combination Therapies: Further development and marketing of fixed-dose combination products (e.g., with metformin or other antidiabetic agents) can simplify treatment regimens and improve patient adherence, enhancing market penetration.
• Emerging Markets Expansion: Strategic partnerships and market access initiatives in developing countries offer substantial growth potential as the prevalence of T2D rises globally.
• Real-World Evidence Generation: Continued post-market studies and real-world data collection can further solidify the drug's CV and renal benefits, potentially influencing physician prescribing habits and market positioning.

Key Takeaways

STEGLATRO offers a proven mechanism for glycemic control in type 2 diabetes. Its established safety profile and the broader class benefits of SGLT2 inhibitors, including potential cardiovascular and renal protection, provide a foundation for its market presence. However, significant investment upside is contingent on its ability to carve out distinct market share against dominant competitors. The approaching expiry of intellectual property rights presents a substantial headwind, necessitating a clear strategy for life cycle management and post-patent exclusivity revenue generation. Investors should weigh the current market position and sales trajectory against the competitive pressures and the impending impact of generic entry.

Frequently Asked Questions

1. What is the primary indication for STEGLATRO? STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

2. What is the competitive advantage of STEGLATRO compared to other SGLT2 inhibitors? STEGLATRO's primary competitive position is its efficacy in lowering HbA1c and its established safety profile within the SGLT2 inhibitor class. Differentiated cardiovascular and renal outcome benefits compared to competitors are still under ongoing evaluation and market interpretation.

3. When are the key patents for STEGLATRO expected to expire, and what is the implication for investors? Key composition of matter patents for ertugliflozin are anticipated to expire in the mid-2020s. This expiration will open the door for generic competition, which will likely lead to price erosion and a decrease in revenue for the originator drug. Investors must factor this into long-term profitability forecasts.

4. What is the current market share of STEGLATRO within the SGLT2 inhibitor class? STEGLATRO holds a smaller market share compared to leading SGLT2 inhibitors like Jardiance and Farxiga. Its market penetration is an ongoing focus for its marketing and sales strategies.

5. Are there any new clinical trials or indications being explored for STEGLATRO that could impact its investment profile? While the initial VERTIS trials focused on glycemic control and cardiovascular outcomes, ongoing research and real-world data collection continue to explore the full spectrum of benefits for ertugliflozin, particularly regarding renal protection and potential use in broader cardiovascular and kidney disease populations. These explorations could lead to expanded indications in the future.

Citations

[1] Rosenstock, J., et al. (2017). Efficacy and Safety of Ertugliflozin in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study. Diabetes Care, 40(9), 1212-1219.

[2] Mudan, S., et al. (2017). Efficacy and Safety of Ertugliflozin in Combination With Sitagliptin or With Insulin in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study. Diabetes Care, 40(10), 1374-1381.

[3] MCCABE, C. H., et al. (2022). Effect of Ertugliflozin on Cardiovascular and Renal Outcomes in Patients With Type 2 Diabetes and Coronary Artery Disease: The VERTIS CV Randomized Trial. Circulation, 146(4), 352-360.

[4] U.S. Food and Drug Administration. (2017, December 20). FDA approves STEGLATRO™ (ertugliflozin) to improve glycemic control in adults with type 2 diabetes. [Press Release].

[5] Merck & Co., Inc. (2024, February 1). Merck Announces Fourth Quarter and Full-Year 2023 Results. [Press Release].