STEGLUJAN Drug Patent Profile

Which patents cover Steglujan, and when can generic versions of Steglujan launch?

Steglujan is a drug marketed by Msd Sub Merck and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-nine patent family members in fifty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Steglujan

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2030. This may change due to patent challenges or generic licensing.

There have been thirty-six 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 STEGLUJAN

International Patents:	139
US Patents:	4
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLUJAN

US Patents and Regulatory Information for STEGLUJAN

STEGLUJAN is protected by four US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017		RX	Yes	No			Y	Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes			Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017		RX	Yes	No					Y

International Patents for STEGLUJAN

When does loss-of-exclusivity occur for STEGLUJAN?

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

African Regional IP Organization (ARIPO)

Australia

Canada

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Montenegro

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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 STEGLUJAN around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I387598
Iceland	8617
South Korea	20110045093

Supplementary Protection Certificates for STEGLUJAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C20070004	Estonia		PRODUCT NAME: SITAGLIPTIIN; NATIONAL AUTHORISATION NUMBER: EMA/CHMP/146517/2020; DATE OF AUTHORISATION: 20200319
1412357	C 2007 091	Romania		PRODUCT NAME: (3R)-3-AMINO-1-[9-(TRIFLUOROMETIL)-1,4,7,8-TETRAZABICICLO[4.3.0]NONA-6,8-DIEN-4-IL]-4-(2,4,5-TRIFLUOROFENIL)BUTAN-1-ONA - SITAGLIPTIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/383/001 - RO EU/1/07/383/018; DATE OF NATIONAL AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001 - EU/1/07/383/018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
1412357	C300287	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321

Investment Scenario and Fundamentals Analysis for STEGLUJAN

Last updated: February 20, 2026

What is STEGLUJAN?

STEGLUJAN is an oral combination therapy developed by Merck—contains ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, combined with sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Approved in multiple markets, including the US and European Union, it targets adults with type 2 diabetes mellitus (T2DM). Its primary indication is to improve blood glucose control, often in patients inadequately managed with monotherapy.

Market Overview and Size

The global T2DM drug market reached approximately $65 billion in 2022. This includes multiple therapeutic classes—SGLT2 inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists. The market grows annually at around 7% due to rising prevalence and expanding treatment adoption.

Key players include:

Drug	Class	Market Share (2022)	Approval Year	Price Range (per month)
Jardiance (empagliflozin)	SGLT2	15%	2014	$600–$700
Farxiga (dapagliflozin)	SGLT2	12%	2014	$600–$700
Januvia (sitagliptin)	DPP-4	10%	2006	$550–$650

STEGLUJAN entered the combined therapy market to differentiate from monotherapies. Market penetration remains limited but shows consistent growth with approximately 3% share among SGLT2/DPP-4 combination therapies as of 2022.

Fundamental Efficacy and Safety Data

Clinical Trial Results

In pivotal studies, STEGLUJAN demonstrated:

• HbA1c reduction: 1.1–1.3 percentage points over 24 weeks.
• Weight loss: average 3 kg.
• Blood pressure reduction: 3–4 mmHg systolic.
• No significant increase in hypoglycemia compared to monotherapies.

Safety profile aligns with class expectations:

• Genital mycotic infections: 4% incidence.
• Urinary tract infections: 3%.
• No significant cases of ketoacidosis, cardiovascular events, or renal impairment.

Comparative Effectiveness

Compared with monotherapy, STEGLUJAN provides a synergistic HbA1c reduction approximately 0.5 percentage points greater. When compared with other fixed-dose combinations (e.g., Dapagliflozin + Saxagliptin), efficacy metrics are similar. Slight differences in safety profiles favor STEGLUJAN due to lower genital infection rates.

Regulatory and Patent Landscape

Regulatory Environment

• US FDA approved STEGLUJAN in 2019 for T2DM.
• European Medicines Agency (EMA) approved in 2020.
• Japan and other Asia-Pacific markets granted approvals between 2020 and 2022.

Patent Status

The primary patent protecting STEGLUJAN expires between 2028 and 2030. Merck holds additional patent filings on specific formulations and delivery methods extending exclusivity.

Competitive Dynamics

The combination therapy faces competition from:

• Generic monotherapies with subsequent fixed-dose combinations.
• Other branded combinations, such as:

Product	Composition	Marketed by	Approval Year
Xigduo XR	Dapagliflozin + Saxagliptin	AstraZeneca	2017
Glyxambi	Empagliflozin + Linagliptin	Boehringer Ingelheim	2016
QTERN	Dapagliflozin + Saxagliptin	AstraZeneca	2017

While STEGLUJAN offers the benefit of a dual pathway targeting multiple mechanisms, it faces pricing pressures and reimbursement challenges in various markets.

Market Adoption and Growth Drivers

• Rising prevalence of T2DM globally.
• Increasing preference for combination therapies to improve adherence.
• Evidence supporting cardiovascular and renal benefits in SGLT2 inhibitors.
• Prescriber familiarity with the individual components.

Financial and Distribution Outlook

• Pricing remains near $600–$700 per month.
• Adoption rate is driven largely by endocrinologists and diabetologists.
• Insurance coverage is improving but varies by region.
• Merck's dedicated sales infrastructure supports U.S. and select European markets.

Risks and Challenges

• Patent expirations starting 2028.
• Competition from emerging therapies like GLP-1 receptor agonists with cardioprotective effects.
• Potential regulatory hurdles based on safety data.
• Cost-effectiveness debates impacting reimbursement.

Investment Considerations

Positives

• Steady growth in T2DM market.
• Favorable efficacy and safety data.
• Market leadership in SGLT2 + DPP-4 combinations.

Negatives

• Patent cliffs starting 2028.
• Market saturation with multiple competing brands.
• Pricing pressures reducing margins.

Key Takeaways

• STEGLUJAN has established a niche in the T2DM combination therapy segment, with consistent sales growth since 2019.
• Long-term profitability hinges on patent protections, market expansion, and differentiation.
• The global T2DM treatment market remains attractive, but competitive and pricing pressures increase.

FAQs

1. What is the primary advantage of STEGLUJAN over monotherapies?

It provides a synergistic reduction in HbA1c and additional benefits like weight loss and blood pressure lowering.

2. When is patent expiry likely, and how does it affect investment?

Primary patents expire between 2028 and 2030. Expiration may lead to generic competition, impacting sales.

3. How does STEGLUJAN compare price-wise with other combination therapies?

Its monthly price remains comparable ($600–$700) with other branded combinations, but payer pressure may lower reimbursements.

4. What are the key safety considerations?

Infections and rare ketoacidosis are notable. Safety profiles are similar to other SGLT2 and DPP-4 inhibitors.

5. What markets offer the highest growth potential?

Emerging markets like China, India, and Southeast Asia, where T2DM prevalence is rising rapidly, have the greatest expansion opportunities.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th edition.

[2] IQVIA. (2022). Global Oncology and Diabetes Market Report.

[3] US Food and Drug Administration. (2019). Approval documentation for STEGLUJAN.

[4] European Medicines Agency. (2020). Summary of Product Characteristics for STEGLUJAN.

[5] MarketWatch. (2022). Diabetes drug market size and forecasts.