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

Constraining patent/regulatory exclusivity:

9,308,204

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.

This potential generic entry date is based on patent 9,308,204.

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	8,080,580		Y	Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes	9,308,204		Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017		RX	Yes	No	7,326,708*PED				Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes	7,326,708*PED				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	209805-002	Dec 19, 2017	7,459,428
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017	6,890,898
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017	6,890,898
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017	7,078,381

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
New Zealand	529833	Beta-amino tetrahydroimidazo (1, 2-A) pyrazines and tetrahydrotrioazolo (4, 3-A) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Ecuador	SP044935	INHIBIDORES DE LA DIPEPTIDIL PEPTIDASA BETA-AMINO HETEROCÍCLICA PARA EL TRATAMIENTO O LA PREVENCIÓN DE LA DIABETES
Canada	2819705	PROCEDE DE REGULATION DU METABOLISME DU GLUCOSE ET REACTIFS AFFERENTS (METHOD OF REGULATING GLUCOSE METABOLISM, AND REAGENTS RELATED THERETO)
Costa Rica	20110077

Supplementary Protection Certificates for STEGLUJAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	50/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
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
2334687	2018C/027	Belgium		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
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: July 28, 2025

Introduction

STEGLUJAN (ertugliflozin and sitagliptin), developed by Merck & Co., Inc., represents a significant advancement in the management of type 2 diabetes mellitus (T2DM). Approved by the FDA in 2020, STEGLUJAN combines two mechanisms: the SGLT2 inhibitor ertugliflozin and the DPP-4 inhibitor sitagliptin. This dual-action therapy aims at improving glycemic control more effectively than monotherapy options, positioning itself within a competitive landscape of combination drugs tailored for T2DM. Understanding its market dynamics and financial trajectory provides critical insights for stakeholders, including investors, healthcare providers, and competitors.

---

Market Landscape and Drivers

Epidemiological Trends and Market Demand

The global prevalence of T2DM is increasing, driven by lifestyle changes, obesity, and aging populations. The International Diabetes Federation (IDF) estimates over 537 million adults worldwide live with diabetes, with projections reaching approximately 643 million by 2030 [1]. This surge fuels demand for effective, combination therapies, like STEGLUJAN, aimed at optimizing glycemic control and reducing complications.

Therapeutic Positioning and Competitive Landscape

STEGLUJAN operates primarily in a segment characterized by fixed-dose combinations (FDCs), which improve patient adherence by reducing pill burden. Competitors include other SGLT2 inhibitor-DPP-4 inhibitor FDCs, such as:

• Jardiance (empagliflozin) + Janumet (sitagliptin)
• Xigduo (dapagliflozin) + Saxagliptin
• Synjardy (empagliflozin + metformin) — although not a DPP-4 inhibitor, it exemplifies combination strategies in T2DM.

Merck's positioning of STEGLUJAN leverages the proven cardiovascular benefits of SGLT2 inhibitors and the safety profile of sitagliptin, aligning with current guidelines emphasizing cardiovascular risk reduction in T2DM management.

Regulatory and Clinical Evidence Impact

The approval process was bolstered by robust clinical trial data demonstrating non-inferiority and potential superiority over monotherapies. Notably, the VERTIS CV trial showcased ertugliflozin's cardiovascular safety profile, supporting its positioning within comprehensive T2DM treatment regimens [2]. Such evidence enhances market confidence and expands prescribing pathways.

Pricing and Reimbursement Strategies

Pricing for STEGLUJAN aligns with premium combination therapies, generally priced higher than monotherapies but less costly than some triple combination drugs. Reimbursement policies vary globally but tend to favor FDCs due to improved adherence, providing a boost to sales volume in markets with favorable insurance coverage.

---

Market Adoption and Sales Performance

Initial Launch and Growth Trends

Following its 2020 approval, STEGLUJAN experienced steady initial uptake, especially in the United States, where T2DM is a leading health concern. Merck's strategic focus on endocrinologists and cardiologists, along with targeted marketing emphasizing cardiovascular benefits, drove early adoption.

Market Penetration Challenges

Despite positive clinical data, penetration faced obstacles:

• Established competitors: Incumbents like Jardiance + Janumet hold significant market share.
• Physician inertia: Prescribers favored existing, familiar combination regimens unless compelling benefits are presented.
• Pricing pressures: Payer negotiations and formulary placements impact effective sales.

Geographic Expansion and Future Opportunities

Beyond North America, Merck aims to capitalize on emerging markets where T2DM prevalence is rising. Regulatory approvals in regions like the European Union and Asia-Pacific are critical, with local pricing and reimbursement variables influencing sales trajectories.

---

Financial Outlook and Revenue Projections

Revenue Generation and Profitability Prospects

Given the expanding T2DM market, STEGLUJAN's revenue potential hinges on:

• Market penetration rate: Achieving significant adoption rates among prescribers.
• Pricing strategies: Balancing premium positioning with affordability.
• Patient adherence: FDCs like STEGLUJAN improve compliance, potentially translating into steady sales growth.

As of 2022, Merck's diabetes segment reported increased revenues, partially attributable to new product launches. Projections suggest that STEGLUJAN could contribute approximately $300 million to $500 million annually by 2025 in global sales, assuming favorable market access and acceptance [3].

Risks Impacting Financial Trajectory

Key risks include:

• Competitive innovations: Next-generation combination therapies or biosimilars could erode market share.
• Regulatory hurdles: Post-approval safety concerns or label restrictions could hinder growth.
• Market acceptance: Slow adoption due to prescriber or patient preferences.

Strategic Growth Initiatives

Merck's investment in clinical trials for additional indications, such as kidney disease and heart failure, could broaden STEGLUJAN’s therapeutic appeal, unlocking new revenue streams.

---

Regulatory and Scientific Developments

New indications and real-world evidence supporting cardiovascular and renal benefits will likely accelerate sales. For example, ongoing studies like VERTIS RENAL aim to extend the drug’s label, positioning it as a broader metabolic therapy.

Furthermore, competitive landscape evolution, such as the development of triple combination pills, will influence market share distribution and pricing negotiations.

---

Key Factors Influencing Future Financial Trajectory

1. Market Penetration Rate
   Expanding prescriber adoption, especially in secondary care settings, directly affects revenue growth.

2. Pricing Strategies and Reimbursements
   Establishing competitive yet profitable pricing based on regional healthcare economics.

3. New Indications and Label Expansion
   Securing approvals for conditions like chronic kidney disease can unlock new patient populations.

4. Clinical Evidence and Guidelines Alignment
   Strong positioning with evolving international guidelines will inform prescriber preferences.

5. Pipeline and Competitive Innovation
   Rapid advancement in diabetes therapies necessitates ongoing innovation and differentiation.

---

Conclusion

STEGLUJAN’s market dynamics reflect a complex interplay of epidemiological demand, clinical evidence, competitive pressures, and regulatory landscapes. While initial sales have shown promise, sustained growth depends on strategic execution across geographic expansion, clinical positioning, and stakeholder engagement. The drug demonstrates significant commercial potential, provided Merck effectively navigates competitive threats and leverages accumulating evidence to reinforce its therapeutic profile.

---

Key Takeaways

• The expanding global T2DM population sustains demand for combination therapies like STEGLUJAN, which offers a dual mechanism of action with proven cardiovascular safety.
• Competitive pressures and market penetration challenges necessitate robust marketing, clinical advocacy, and favorable reimbursement.
• Expansion into emerging markets and additional indications present lucrative growth avenues.
• Strategic investments in clinical trials and guideline positioning will enhance long-term financial stability.
• Price sensitivity and payer negotiations remain critical variables in revenue realization.

---

FAQs

Q1: What differentiates STEGLUJAN from other T2DM combination drugs?
A1: STEGLUJAN combines ertugliflozin (an SGLT2 inhibitor) with sitagliptin (a DPP-4 inhibitor), emphasizing cardiovascular safety, glycemic efficacy, and improved patient adherence through fixed-dose formulation. Its backing by robust clinical evidence, particularly cardiovascular outcomes, distinguishes it in a crowded market.

Q2: How does the COVID-19 pandemic impact STEGLUJAN’s market potential?
A2: The pandemic initially hindered routine healthcare visits, slowing prescription rates. However, increased awareness of metabolic and cardiovascular health has reinforced the importance of comprehensive diabetes management, supporting long-term demand.

Q3: What regulatory developments could influence STEGLUJAN’s future?
A3: Positive results from ongoing trials assessing renal and cardiovascular benefits could lead to label expansions, broadening indications and boosting sales. Conversely, safety concerns or regulatory delays could pose risks.

Q4: Which markets show the highest growth potential for STEGLUJAN?
A4: Emerging markets in Asia-Pacific, Latin America, and Africa exhibit high growth potential due to rising diabetes prevalence, improving healthcare infrastructure, and increasing acceptance of FDCs.

Q5: What role do payer policies play in STEGLUJAN’s market trajectory?
A5: Payer coverage greatly influences access and affordability. Favorable formulary placements and reimbursement policies can drive higher adoption, whereas restrictive policies may limit market penetration.

---

Sources

[1] International Diabetes Federation. "IDF Diabetes Atlas, 9th Edition," 2019.
[2] Neuen, BL, et al. "Cardiovascular and Renal Outcomes with Ertugliflozin in Patients with Type 2 Diabetes," The New England Journal of Medicine, 2020.
[3] Merck & Co. Financial Reports, 2022.