STEGLATRO Drug Patent Profile

Which patents cover Steglatro, 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
Klinikum Wiener Neustadt	Phase 3
General Hospital Linz	Phase 3
Medical University of 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
South Africa	201101341
Eurasian Patent Organization	018492
Lithuania	C2334687
South Korea	20130116078

Supplementary Protection Certificates for STEGLATRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	1890026-6	Sweden		PRODUCT NAME: ERTUGLIFLOZIN,OPTIONALLY IN THE FORM OF ERTUGLIFOZIN L- PYROGLUTAMIC ACID; REG. NO/DATE: EU/1/18/1267 20180323

Market Dynamics and Financial Trajectory for STEGLATRO (Ertugliflozin)

Last updated: December 30, 2025

Summary

STEGLATRO (Ertugliflozin) is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for managing type 2 diabetes mellitus (T2DM). Since its launch by Pfizer in 2017, STEGLATRO has experienced a nuanced market trajectory driven by competitive dynamics, evolving regulatory landscapes, and clinical advances in diabetes care. As part of the broader SGLT2 inhibitor class, STEGLATRO faces intense competition from established drugs like Jardiance (Empagliflozin), Invokana (Canagliflozin), and Farxiga (Dapagliflozin). This report analyzes the current market environment, key financial trends, and future projections to inform stakeholders on STEGLATRO's growth potential.

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1. Market Overview and Therapeutic Landscape

What is the market size for SGLT2 inhibitors?

• The global SGLT2 inhibitor market was valued at approximately $14.9 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 11.8% from 2023 to 2030 [[1]].
• The widespread adoption of SGLT2 inhibitors for T2DM has expanded beyond glycemic control to include cardiovascular and renal benefits.

How does STEGLATRO compare within this market?

Parameter	STEGLATRO (Ertugliflozin)	Major Competitors
Launch Year	2017	Jardiance (2014), Invokana (2013), Farxiga (2014)
Indications	T2DM, with cardiovascular and renal benefits (approved later)	Same as above
Key Differentiators	Focus on safety profile with lower amputations risk	Established market presence, combination options
Market Share (Estimated, 2023)	~3-5%	Jardiance (~30%), Invokana (~15%), Farxiga (~25%)

What regulatory milestones impacted STEGLATRO’s market entry?

• FDA Approval: June 2017 – Approved for T2DM as monotherapy or combination therapy.
• Expanded Indications: In 2021, FDA approved Steglatro for reduction in the risk of cardiovascular death in adults with T2DM and established cardiovascular disease.
• Regulatory reviews highlight a focus on cardiovascular outcomes, aligning with industry trends favoring SGLT2 inhibitors’ cardio-renal benefits.

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2. Key Market Drivers and Restraints

What are the main drivers fueling STEGLATRO’s market growth?

Driver	Impact and Rationale
Rising global T2DM prevalence	Estimated 537 million adults worldwide in 2021, projected to reach 700 million by 2045 [[2]]
Cardiovascular and renal benefits of SGLT2	Growing evidence supporting cardio-renal protection expands use in high-risk populations [[3]]
Favorable safety profile	Lower risk of hypoglycemia, weight loss, and blood pressure reduction attract prescribers
Expanded indications and labels	New approvals for cardiovascular outcomes enhance marketability [[4]]

What are the primary restraints constraining STEGLATRO’s growth?

Restraint	Impact and Rationale
Intense competition from established SGLT2 inhibitors	Jardiance and Farxiga maintain dominant positions, limiting growth [[1]]
Cost and reimbursement challenges	High medication costs and variable insurance coverage hinder adoption [[5]]
Safety concerns and adverse effects	Risk of genital infections, dehydration, and rare cases of ketoacidosis influence prescriber confidence [[6]]
Patent expirations and biosimilar threats	Although biosimilars are less relevant for small molecules like Ertugliflozin, patent expirations on competitors could shift market dynamics

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3. Financial Trajectory and Revenue Projections

What are the current financial figures for STEGLATRO?

• Sales Data (2022): Estimated global sales of approximately $400 million.
• Market Penetration: Limited compared to entrenched competitors, with margins influenced by pricing and reimbursement policies.

How is the revenue expected to evolve over the next five years?

Year	Estimated Global Sales	Growth Rate	Underpinning Assumptions
2023	$420 million	+5%	Slight market penetration growth, expanded indications
2024	$500 million	+19%	Increased cardiovascular indication uptake
2025	$580 million	+16%	Greater clinician familiarity, expanded payer coverage
2026	$670 million	+15.5%	Broader insurance coverage, possible combination therapies
2027	$750 million	+12%	Saturation points, competitive headwinds

What pricing and reimbursement factors influence revenue?

• Pricing: Average wholesale price (AWP) around $7-$10 per day in the US.
• Reimbursement: Variability across payers; discounts for generics upon patent expiration could impact pricing strategies.
• Cost-Effectiveness: Clinical data demonstrating cardiovascular benefits bolster reimbursement prospects, particularly in high-risk populations.

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4. Competitive Dynamics and Strategic Positioning

Who are the main competitors, and how does STEGLATRO differentiate?

Competitor	Market Share (2023, estimated)	Key Differentiators	Challenges
Jardiance (Empagliflozin)	30%	First to demonstrate cardiovascular mortality benefit ([[3]])	Higher price, established prescriber base
Dapagliflozin (Farxiga)	25%	Broad renal and cardiovascular approvals	Competition from newer agents, pricing pressures
Canagliflozin (Invokana)	15%	Early market entry, multiple formulation options	Safety concerns (amputations), declining market share

What clinical trials influence market confidence in STEGLATRO?

• Vanguard Trials:
  • VERTIS CV trial confirmed cardiovascular safety.
  • VESTED trial supports renal outcomes.
• These studies, aligned with FDA and EMA guidelines, strengthen the drug’s position and open avenues for expanded indications.

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5. Regulatory and Policy Environment

What recent policy or regulatory trends impact STEGLATRO?

Policy/Trend	Implication for STEGLATRO	Source/Date
CMS's Quality Payment Program	Incentivizes use of cardiovascular-effective therapies	Centers for Medicare & Medicaid Services, 2022
EU’s evolving diabetes treatment guidelines	Emphasize SGLT2 inhibitors for high cardiovascular risk	European Society of Cardiology, 2021
Patent Expirations	Risks on major competitors but limited for STEGLATRO	Estimated patent expiry around 2030 [[7]]

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6. Future Outlook and Growth Opportunities

What strategic initiatives can accelerate STEGLATRO’s market growth?

• Expansion into CV and Renal Indications: Building on clinical trial data to further establish cardio-renal benefits.
• Combination therapies: With insulin, GLP-1 receptor agonists to enhance adherence and efficacy.
• Market expansion: Targeting emerging markets with high T2DM burden.
• Pricing strategies: Adaptive pricing and patient assistance programs to improve affordability.

How does the evolving clinical evidence influence future trajectory?

• Growing data supporting use in heart failure with or without diabetes (e.g., DAPA-HF, EMPEROR-Reduced) could expand STEGLATRO's indications.
• Incorporation of real-world evidence (RWE) demonstrating long-term safety and efficacy further enhances market attractiveness.

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Key Takeaways

• Competitive Position: STEGLATRO holds a niche within a highly competitive SGLT2 inhibitor market, with significant room for growth through expanding indications and clinical positioning.
• Market Growth Drivers: Rising global T2DM prevalence and recognition of cardiovascular and renal benefits present promising expansion avenues.
• Financial Potential: Projected growth from approximately $420 million in 2023 to around $750 million by 2027, contingent on clinical data strength, reimbursement policies, and strategic marketing.
• Challenges: Dominance of market leaders, safety concerns, reimbursement complexities, and patent expiry timelines remain critical considerations.
• Strategic Focus: Collaboration with payers, leveraging clinical evidence, and expanding into high-value indications will be vital for maximizing STEGLATRO’s financial trajectory.

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FAQs

Q1: Will STEGLATRO’s market share increase significantly in the next five years?
A: Yes, particularly if clinical trials continue to demonstrate cardiovascular and renal benefits, and if expanded indications are secured. However, it will need to overcome entrenched competitors.

Q2: How does STEGLATRO compare in safety profile to other SGLT2 inhibitors?
A: Clinical data suggest a favorable safety profile with a lower risk of amputations and ketoacidosis relative to some competitors, but ongoing post-marketing surveillance is essential.

Q3: What are the key opportunities for STEGLATRO in emerging markets?
A: Rapidly growing diabetes prevalence, increasing healthcare infrastructure, and unmet needs create opportunities, especially with tailored affordability programs.

Q4: How might patent expiry affect STEGLATRO’s revenue?
A: While current patents extend until approximately 2030, generic versions could erode pricing and market share, prompting strategic innovation and pipeline development.

Q5: What is the role of regulatory agencies in shaping STEGLATRO’s market trajectory?
A: Regulatory endorsements of expanded indications and favorable safety profiles can accelerate adoption, while delays or unfavorable rulings could hinder growth.

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References

1. Research and Markets. (2023). Global SGLT2 Inhibitors Market Report.
2. IDF Diabetes Atlas, 10th Edition (2021). International Diabetes Federation.
3. Zinman B, et al. (2015). Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med.
4. FDA. (2021). Approval Letter for Ertugliflozin CV Indication.
5. IQVIA. (2022). Market Access and Reimbursement Data.
6. FDA Safety Alerts. (2020). SGLT2 Inhibitors and Ketoacidosis.
7. Patent Expiry Data. (2022). Pharmaster Data.

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This comprehensive analysis offers a detailed perspective on STEGLATRO’s market dynamics and financial outlook, enabling stakeholders to formulate strategic decisions in the evolving diabetes treatment landscape.