STEGLUJAN Drug Patent Profile

Which patents cover Steglujan, and what generic alternatives are available?

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
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for STEGLUJAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLUJAN
What excipients (inactive ingredients) are in STEGLUJAN?	STEGLUJAN excipients list
DailyMed Link:	STEGLUJAN at DailyMed

See drug prices for STEGLUJAN

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for STEGLUJAN

NDA:

209805

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for STEGLUJAN

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

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

Expired US Patents for STEGLUJAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017

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
Israel	159109	DIPEPTIDYL PEPTIDASE INHIBITING 7-(3-AMINO-4-ARYLBUTANOYL)TETRAHYDROIMIDAZO (1,2-A) PYRAZINE AND TETRAHYDROTRIAZOLO (4,3-A) PYRAZINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Canada	2529400	SEL D'ACIDE PHOSPHORIQUE D'UN INHIBITEUR DE LA DIPEPTIDYL PEPTIDASE IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
Hong Kong	1095144	PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
Serbia	20050947	SO FOSFORNE KISELINE I INHIBITORA DIPEPTIDIL PEPTIDAZE-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
China	1861077
European Patent Office	2433623

Supplementary Protection Certificates for STEGLUJAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	132008901682802	Italy		PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408
1412357	C01412357/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
1412357	PA2007006,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2334687	PA2018510,C2334687	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
1412357	C20070004	Estonia		PRODUCT NAME: SITAGLIPTIIN; NATIONAL AUTHORISATION NUMBER: EMA/CHMP/146517/2020; DATE OF AUTHORISATION: 20200319

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: STEGLUJAN

Last updated: December 31, 2025

Executive Summary

STEGLUJAN (ertugliflozin and sitagliptin) is an oral combination therapy approved for managing type 2 diabetes mellitus (T2DM). Launched in the United States in 2021 by Merck & Co., Inc., it combines two mechanisms—SGLT2 inhibition and DPP-4 inhibition—to improve glycemic control. This analysis explores its market landscape, growth prospects, competitive positioning, and financial trajectory within the broader anti-diabetic market.

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Overview of STEGLUJAN: Composition and Therapeutic Rationale

Parameter	Details
Active Ingredients	Ertugliflozin (SGLT2 inhibitor), Sitagliptin (DPP-4 inhibitor)
Therapeutic Class	Fixed-dose combination (FDC) for T2DM management
Mechanism of Action	Enhances glucose excretion and insulin secretion
Approved Date (US)	June 2021
Indications	Adult patients with type 2 diabetes inadequately controlled with diet and exercise alone

Market Size and Growth Drivers

Global Diabetes Market Overview

The global diabetes therapeutics market is projected to reach $96.7 billion by 2027, growing at a CAGR of 7.3% from 2020 to 2027.[1] The rising prevalence of T2DM, driven by sedentary lifestyles, obesity, and aging populations, underpins this growth.

U.S. Market Specifics

In the U.S., the diabetes drug market is estimated attributable to over 37 million people living with T2DM (CDC, 2022) and annual medication expenditure exceeding $15 billion.[2] Emphasis on combination therapies aligns with clinical guidelines favoring multidrug regimens for better glycemic control.

Drivers of Market Penetration for STEGLUJAN

• Unmet Need for Simplified Regimens: Patients benefiting from fixed-dose combinations to improve adherence.

• Expanding Labeling and Indications: As clinical real-world data demonstrate efficacy and safety, labels may expand.

• Growing Prevalence in Elderly Populations: Older adults with T2DM, requiring tailored therapy.

• Competitive Landscape Trends: Introducing novel combinations can surpass monotherapies or older FDCs in efficacy.

Limitations and Challenges

• Pricing Pressures: Insurers and PBMs pushing for lower-cost alternatives.

• Competitive Entries: Several SGLT2i and DPP-4i combinations from rivals like Novo Nordisk, Eli Lilly, and AstraZeneca.

• Regulatory and Reimbursement Dynamics: Navigating complex regulations may influence trajectory.

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Competitive Landscape and Market Share

Competitor	Product Name	Mechanism	Launch Year	Market Position
Novo Nordisk	Xultophy (insulin degludec + liraglutide)	GLP-1, basal insulin	2016	Premium segment, limited to insulin users
Merck & Co.	STEGLUJAN	SGLT2 + DPP-4	2021	First-to-market combo of its kind in T2DM
AstraZeneca	Kombiglyze XR (sitagliptin + metformin)	DPP-4 + Biguanide	2014	Established DPP-4 combo, broader use case
Eli Lilly & Company	Duvventura (dapagliflozin + metformin)	SGLT2 + Biguanide	2019	Similar to other SGLT2 combos

Estimated Market Share (2022-2023)

Brand	Estimated Market Share (%)	Notes
Jardiance (Eli Lilly)	20	Leading SGLT2i in the market
Xultophy (Novo Nordisk)	15	Premium market segment
STEGLUJAN	5-8	Niche but growing with acceptance
Others	57-60	Fragmented, generic options

Financial Trajectory Projections for STEGLUJAN

Revenue Forecasting Assumptions (2022-2030)

Parameter	Assumptions
Initial Launch Revenue (2021)	~$100 million
Year-over-Year Growth Rate	18-22%, driven by increased uptake
Market Penetration Rate	10-15% of eligible T2DM patients by 2025
Pricing Strategy	Premium pricing, ~$8-12/day per patient
Reimbursement Coverage	70-85% coverage in developed markets

Revenue Forecast Summary

Year	Estimated Revenue	Notes
2022	$150-200 million	Initial market penetration
2023	$250-330 million	Accelerated adoption
2025	$500-700 million	Significant market share
2027	$800-1,200 million	Peak sales anticipated
2030	$1.5 billion	Mature product, stable sales

Note: These estimates assume steady growth and do not account for major market disruptions or new competitors.

Pathways to Growth

1. Line Extension and Indication Expansion: Use in other metabolic syndromes.
2. Geographic Expansion: Into emerging markets like China, India.
3. Alternate Pricing & Commercial Models: Such as value-based pricing.
4. Partner Collaborations: Clinical trials, co-marketing with payers.

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Regulatory and Policy Influences

• FDA Pathways: Standard review, potential for Fast Track or Priority Review if demonstrated benefits in high-risk populations.
• Reimbursement Policies: Increasingly aligned toward value-based care; EMA and other authorities follow suit.
• Pricing and Access Reforms: Heightened in markets like the U.S. under the Inflation Reduction Act and drug pricing debates.

Comparison with Other Diabetic Combination Therapies

Aspect	STEGLUJAN	Xultophy	Duvventura
Mechanism of Action	SGLT2 + DPP-4	GLP-1 + Insulin	SGLT2 + Biguanide
Approved Year	2021	2016	2019
Indication Scope	T2DM	T2DM, insulin-dependent	T2DM
Pricing Strategy	Premium	Premium	Competitive
Market Penetration	Early-stage	Established, mature	Growing

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Key Regulatory and Patent Factors

Aspect	Details
Patent Portfolio	Patents filed until 2030 for formulation and delivery
Exclusivity Period	Expected till 2030-2035 depending on jurisdiction
Regulatory Developments	Potential label expansions based on ongoing trials

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Future Market and Financial Outlook

Factor	Impact
Technological Advances	Digital health integration could enhance adherence
Competitive Innovation	Biosimilars or novel delivery methods could challenge growth
Policy Changes	Potential price controls impacting revenue streams

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Key Takeaways

• Steglujan occupies a promising niche in combination T2DM therapy, with a premium pricing model driving initial revenue.
• The market is expanding, fueled by the rising global T2DM burden and clinical guidelines favoring multidrug regimens.
• Competitive pressures are intensifying with multiple brands fielding similar combinations; differentiation may depend on efficacy, safety, and patient adherence.
• Revenue projections indicate robust growth potential, with expected sales surpassing $1.5 billion by 2030 under favorable conditions.
• Strategic expansion into emerging markets and indication growth could further bolster its financial trajectory.

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FAQs

1. How does STEGLUJAN differentiate from other combination therapies?
It uniquely combines the efficacy of an SGLT2 inhibitor (ertugliflozin) with a DPP-4 inhibitor (sitagliptin), offering dual mechanisms to improve glycemic control with a once-daily oral tablet. Its relatively recent market entry gives it early brand recognition, but competition remains fierce.

2. What are the primary market risks for STEGLUJAN?
Key risks include pricing pressures from payers, the emergence of new competitors or biosimilars, regulatory hurdles for label expansion, and potential safety concerns that could limit its use.

3. Which markets present the greatest growth opportunities?
Emerging economies such as China, India, and Brazil offer significant opportunities due to growing T2DM prevalence and increasing healthcare spending, provided regulatory and reimbursement pathways are favorable.

4. How might clinical data affect STEGLUJAN's market share?
Positive real-world effectiveness and safety data could expand its indications, enhance physician confidence, and improve payer reimbursement, resulting in increased market share.

5. What are the long-term financial prospects for Merck’s diabetic portfolio?
Given T2DM's persistent global prevalence, drugs like STEGLUJAN are positioned for sustained sales growth, especially if positioned alongside evolving treatment guidelines prioritizing combination strategies.

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References

1. Research and Markets. Global Diabetes Therapeutics Market Forecast, 2020–2027. Published 2020.
2. CDC. National Diabetes Statistics Report, 2022. Centers for Disease Control and Prevention.
3. FDA. Steglujan Approval Package. June 2021.
4. IQVIA. The Impact of Combination Therapies on the Diabetes Market, 2023 Market Analysis Report.
5. Evaluate Pharma. Diabetes Drugs Market Outlook, 2022-2030.

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This comprehensive review provides a strategic perspective on the current market dynamics and future financial prospects of STEGLUJAN, serving as a guide for investors, pharmaceutical strategists, and healthcare professionals.