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
Wilhelminenspital Vienna	Phase 3
Klinikum Wiener Neustadt	Phase 3
General Hospital Linz	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			Y	Y
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017		RX	Yes	Yes			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
Malaysia	155418
Israel	211226
El Salvador	2011003842
China	103497199
Panama	8840801
Mexico	2011002166

Supplementary Protection Certificates for STEGLATRO

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	C02334687/01	Switzerland		FORMER OWNER: PFIZER INC., US
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	716	Finland
2334687	2018/028	Ireland		PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 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

Market Dynamics and Financial Trajectory for STEGLATRO (Ertugliflozin)

Last updated: July 27, 2025

Introduction

STEGLATRO, developed by Merck & Co., is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM). Since its US approval in 2017, STEGLATRO has contributed to Merck's cardiovascular and metabolic portfolio, positioning itself amidst a competitive landscape characterized by rapid innovation, increasing global diabetes prevalence, and evolving payer and prescribing paradigms. This analysis examines the market environment influencing STEGLATRO, alongside projected financial trajectories informed by current trends, clinical data, and strategic positioning.

Global and Regional Market Overview

Global Diabetes Treatment Market

The global diabetes therapeutics market was valued at approximately USD 64 billion in 2022 and is projected to reach USD 98 billion by 2030, growing at a CAGR of 5-6% (source: Grand View Research). This growth is driven by rising prevalence, demographic shifts, and earlier diagnosis. The proliferation of incretin-based therapies and SGLT2 inhibitors has reshaped the treatment paradigm, favoring drugs with demonstrated cardiovascular and renal benefits.

SGLT2 Inhibitors Market

SGLT2 inhibitors have become a dominant class within T2DM management, estimated to account for nearly 30-35% of oral antidiabetic prescriptions globally by 2025 (source: IQVIA). Key players include Johnson & Johnson (Jardiance), AstraZeneca (Farxiga), Lilly/Boehringer (Invokana), and Merck (Steglatro). The class is distinguished not only by glycemic control but also by robust evidence for cardioprotective and nephroprotective effects, expanding their usage beyond glycemic endpoints.

Market Position of STEGLATRO

While Jardiance leads the segment with a significant market share, STEGLATRO has carved out a niche through targeted clinical indications, such as reducing cardiovascular risk in T2DM. However, Merck faces steep competition from entrenched rivals, necessitating strategic differentiation through clinical data, marketing, and partnerships.

Market Drivers

Expanding Global Diabetes Burden

The International Diabetes Federation estimates over 530 million adults with diabetes worldwide, expected to reach 700 million by 2045 (IDF Diabetes Atlas, 9th edition). This burgeoning patient population sustains demand for effective, convenient, and safe therapies like STEGLATRO.

Cardiovascular and Renal Benefits

The DECLARE-TIMI 58 trial showed Farxiga's superiority in reducing hospitalizations for heart failure and renal progression, bolstering the market for SGLT2 inhibitors with cardiovascular indications. Merck emphasizes STEGLATRO’s CVOS (cardiovascular outcomes study) data, aiming to differentiate it further.

Shift Towards Oral, Once-Daily Therapeutics

Patient preference favors oral medications with favorable safety profiles. STEGLATRO’s oral administration, combined with a once-daily dosing regimen, enhances adherence and therapeutic engagement.

Regulatory and Reimbursement Environment

Regulatory agencies increasingly endorse SGLT2 inhibitors for multiple indications, including heart failure and chronic kidney disease (CKD). Payers are gradually recognizing their cost-effectiveness in reducing hospitalizations and delaying disease progression.

Market Challenges

Intense Competition

Jardiance maintains a dominant market share, substantiated by extensive clinical data (EMPAREG OUTCOME, EMPA-REG), and strategic marketing. Farxiga also benefits from broad indications. Merck must grapple with these entrenched competitors, which possess significant marketing resources.

Pricing and Reimbursement Pressures

Global cost-containment measures pressure pharmaceutical pricing. While SGLT2 inhibitors have demonstrated long-term savings, upfront drug costs remain scrutinized, especially in emerging markets.

Safety and Tolerability Concerns

Adverse events, including genital infections, euglycemic diabetic ketoacidosis, and concerns about volume depletion, affect prescribing patterns. Ensuring favorable safety profiles remains vital for sustained adoption.

Regulatory Updates and Label Changes

Evolving regulatory guidance concerning SGLT2 inhibitors' safety profiles can influence prescribing and market access landscapes. Post-marketing safety signals necessitate ongoing vigilance, impacting market confidence.

Financial Trajectory and Revenue Forecasting

Historical Sales and Growth Trends

Since its launch, STEGLATRO’s revenue has been moderate compared to market leaders, with estimated 2022 global sales around USD 300 million. The growth trajectory has been steady, yet it remains highly dependent on volume expansion and geographical penetration.

Strategic Initiatives and Expansion Potential

Merck’s clinical programs aim to support additional indications, particularly in heart failure with preserved ejection fraction (HFpEF) and CKD. Positive outcomes could catalyze rapid sales expansion, akin to J&J’s Jardiance.

Forecast Scenarios

• Conservative Scenario: With primary reliance on existing indications and steady penetration, STEGLATRO’s revenue could grow at a CAGR of 4-6% over the next five years, reaching approximately USD 500-600 million by 2028.

• Optimistic Scenario: Successful expansion into broader cardiovascular and renal indications, supplemented by increased adoption in emerging markets, could propel annual sales beyond USD 1 billion by 2030.

• Market Share Assumptions: Achieving a 15-20% share of the SGLT2 inhibitor class in T2DM globally would necessitate significant marketing investment, clinician education, and favorable clinical outcomes.

Pricing Trends and Reimbursement Impact

Pricing strategies are expected to evolve, with potential discounts in emerging markets and value-based pricing models globally. Payer acceptance, driven by demonstrated cost savings and long-term health benefits, remains critical.

Regulatory and Clinical Development Trajectory

Regulatory agencies are scrutinizing SGLT2 inhibitors' cardiovascular and renal benefits, influencing label expansions. Merck’s ongoing trials aim to solidify STEGLATRO’s positioning in heart failure and CKD management, potentially unlocking new revenue streams.

Partnerships and Market Access Strategies

Strategic collaborations with payers, healthcare systems, and healthcare provider networks can accelerate market access. Merck’s partnerships in Asia and Europe are pivotal in expanding usage and reducing regional market disparities.

Key Market Trends Impacting Financial Outcomes

• Growing Evidence Base: Positive trial data will bolster clinician confidence and use-case expansion.
• Integration with Multimodal Therapy: Combining STEGLATRO with other cardiometabolic drugs can optimize treatment regimens, increasing sales.
• Digital and Patient Engagement: Telehealth integration and digital adherence tools can improve outcomes and boost market penetration.

Conclusion

The financial trajectory of STEGLATRO remains promising yet competitive. Its success hinges on clinical validation, strategic marketing, reimbursement pathways, and expanding indications. Given the broader shift towards cardio-renal protective therapies for T2DM, STEGLATRO’s growth outlook is cautiously optimistic, with substantial upside provided Merck leverages ongoing clinical developments and international market expansion.

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Key Takeaways

• Market Positioning: STEGLATRO operates within a highly competitive SGLT2 inhibitor market, necessitating differentiation through robust cardiovascular and renal benefits demonstration.
• Growth Drivers: The rising global diabetes burden, expanding indications, and shifting treatment paradigms favor STEGLATRO’s growth potential.
• Challenges: Competition from Jardiance and Farxiga, safety concerns, and pricing pressures represent primary hurdles.
• Forecasting Potential: Under favorable clinical and regulatory conditions, STEGLATRO could reach annual sales above USD 1 billion by 2030, contingent on successful indication expansion and market access strategies.
• Strategic Imperative: Merck’s focus on clinical trials, partnerships, and value-based pricing will be pivotal in shaping the drug’s financial trajectory.

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FAQs

1. What are the primary clinical advantages of STEGLATRO over competitors?
   While all SGLT2 inhibitors share core glycemic effects, STEGLATRO’s ongoing trials aim to substantiate specific cardiovascular and renal benefits, potentially offering differentiated therapeutic value in expanded indications.

2. How does regulatory approval impact STEGLATRO’s market potential?
   Regulatory approvals for additional indications, especially in heart failure and CKD, can substantially increase its addressable market and revenue streams by broadening patient eligibility.

3. What are the main barriers to STEGLATRO’s market growth?
   Key barriers include intense competition, safety profile considerations, reimbursement hurdles, and market penetration challenges in emerging regions.

4. How significant is the role of clinical trial data in shaping the drug’s financial outlook?
   Very significant; positive data can facilitate label expansions, strengthen clinician confidence, and influence payer decisions, directly impacting sales performance.

5. What strategies should Merck adopt to maximize STEGLATRO’s market share?
   Merck should focus on advancing evidence generation, fostering international partnerships, engaging healthcare providers through education, and advocating for favorable reimbursement policies.

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References:

1. Grand View Research. (2023). Diabetes Therapeutics Market Size, Share & Trends Analysis Report.
2. IQVIA. (2022). The Future of Diabetes and Cardiovascular Therapies.
3. International Diabetes Federation. (2022). IDF Diabetes Atlas, 9th Edition.
4. FDA. (2017). Approval Letter for Ertugliflozin (STEGLATRO).
5. Publicly available clinical trial data (DECLARE-TIMI 58, EMPAREG OUTCOME).