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
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes

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
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
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	209805-001	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
Argentina	036114	TETRAHIDROIMIDAZOL[1,2-A]PIRAZINAS Y TETRAHIDROTRIAZOL[4,3-A]PIRAZINAS COMO INHIBIDORES DE LA DIPEPTIDIL PEPTIDASA UTILES PARA EL TRATAMIENTO O LA PREVENCION DE LA DIABETES
Austria	321048
Austria	471148
Australia	2002320303
Bulgaria	108493
Brazil	0210866
Brazil	PI0210866	compostos beta-amino tetra-hidroimidazo (1,2-a) pirazina e tetra-hidrotriazolo (4,3-a) pirazina, usos dos mesmos e composição farmacêutica

Supplementary Protection Certificates for STEGLUJAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	PA2007006	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
1412357	SPC/GB07/046	United Kingdom		PRODUCT NAME: SITAGLIPTIN PHOSPHATE MONOHYDRATE; REGISTERED: UK EU/1/07/383/001 20070323; UK EU/1/07/383/002 20070323; UK EU/1/07/383/003 20070323; UK EU/1/07/383/004 20070323; UK EU/1/07/383/005 20070323; UK EU/1/07/383/006 20070323; UK EU/1/07/383/007 20070323; UK EU/1/07/383/008 20070323; UK EU/1/07/383/009 20070323; UK EU/1/07/383/010 20070323; UK EU/1/07/383/011 20070323; UK EU/1/07/383/012 20070323; UK EU/1/07/383/013 20070323; UK EU/1/07/383/014 20070323; UK EU/1/07/383/015 20070323; UK EU/1/07/383/016 20070323; UK EU/1/07/383/017 20070323; UK EU/1/07/383/018 20070323
1412357	122007000056	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1412357	CA 2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1412357	91470	Luxembourg		91470, EXPIRES: 20280818
1412357	PA2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1412357	C20080004 00019	Estonia		PRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID

Last updated: June 5, 2026

STEGLUJAN (ertugliflozin/sitagliptin) market dynamics and financial trajectory: sales trends, payer positioning, competition, and revenue risk

STEGLUJAN (ertugliflozin/sitagliptin) is an SGLT2 inhibitor plus DPP-4 inhibitor fixed-dose combination launched in the US in 2018. Its financial trajectory has been shaped by (1) payer access and formulary tiering versus individual components, (2) shifting clinical and guideline preference toward SGLT2 inhibitor and GLP-1 receptor agonist regimens, and (3) competitive intensity from other SGLT2/DPP-4 combinations and GLP-1-focused portfolios. Exact revenue totals are not provided in the available dataset, but the commercial pattern is consistent with a branded combo with limited long-term franchise expansion once members of its class consolidate share.

How has STEGLUJAN performed financially since launch?

Quick answer: STEGLUJAN’s post-launch growth has been constrained by formulary substitution toward SGLT2-only or GLP-1-based strategies and by the ability of payers to achieve similar outcomes via separate generics/brand components.

US launch and adoption path

• Launch: 2018 (US).
• Category: SGLT2 inhibitor (ertugliflozin) + DPP-4 inhibitor (sitagliptin) fixed-dose combination.
• Intended value: Simplify therapy for patients needing add-on from metformin and/or who would otherwise add a DPP-4 to an SGLT2.

What usually drives STEGLUJAN revenue in-year

• Formulary placement relative to:
  • SGLT2 inhibitors alone (often preferred for cardiorenal outcomes).
  • GLP-1 receptor agonists (weight loss and glycemic durability).
  • Separate tablets when DPP-4 and SGLT2 are on cheaper tiers or available with strong rebates.
• Persistency and dose migration:
  • DPP-4 monotherapy is increasingly replaced by GLP-1 and SGLT2 intensification.
  • Patients who start on combination therapies may transition off DPP-4 components as treatment algorithms evolve.

What market dynamics affect STEGLUJAN demand most?

Quick answer: The dominant demand drivers are payer economics versus alternative add-on classes and the clinical shift toward SGLT2 and GLP-1 intensification, which reduces the incremental role for DPP-4.

Therapeutic competition inside type 2 diabetes

• Clinical steering toward:
  • SGLT2 inhibitors for heart failure and CKD risk reduction.
  • GLP-1 receptor agonists for weight and cardiovascular risk reduction.
• In practice, once an SGLT2 inhibitor is on formulary with strong access, adding a DPP-4 may be harder to defend economically.

Payer design and contracting mechanics

• Pharmacy benefit managers typically:
  • Use rebate structures to steer utilization to preferred agents within SGLT2 and GLP-1 classes.
  • Penalize fixed-dose combinations when separate components can be assembled at lower cost or with preferred NDCs.
• Fixed-dose combos face heightened substitution pressure when either component has:
  • More favorable net cost,
  • Better formulary tier placement,
  • Broader patient coverage criteria.

Patient and prescriber behavior

• Fixed-dose combinations reduce pill burden, but prescribers still switch quickly if:
  • Glycemic targets are missed with one combination,
  • Safety signals or comorbidity profiles favor alternative classes,
  • Outcomes focus (heart failure/CKD) points to SGLT2 monotherapy or SGLT2 + GLP-1 sequences.

Which competitors most constrain STEGLUJAN share?

Quick answer: STEGLUJAN competes primarily against SGLT2 inhibitors used as standalone therapy, GLP-1 receptor agonists, and competing fixed-dose combinations that may price and contract more effectively.

Key competitive buckets

1. SGLT2 inhibitors (standalone)

   • Competitive pressure rises when formulary design prioritizes SGLT2 agents due to outcomes data and payer preference.

2. GLP-1 receptor agonists

   • Weight loss and glycemic durability drive substitution, particularly when payers have supportive rebates.

3. Other combination strategies

   • Combination products or multi-pill regimens using preferred DPP-4 or SGLT2 agents can undercut fixed-dose pricing.

Net effect on STEGLUJAN

• Market share is vulnerable even with differentiated clinical positioning because many payer formularies operate at the class level and enforce preferred-agent pathways.

When does STEGLUJAN face major revenue risk from exclusivity or generic entry?

Quick answer: The revenue risk profile is tied to the expiration of composition-of-matter and formulation patents and to any generic or authorized generic entry of the fixed-dose combination and/or its components. The dataset available here does not include an Orange Book-style exclusivity and patent-expiration matrix for STEGLUJAN, so specific dates cannot be stated.

Practical revenue-risk channels

• Fixed-dose combination entry risk:
  • A generic version of ertugliflozin/sitagliptin would compress pricing quickly.
• Component-level substitution risk:
  • Even before combination generic entry, strong uptake of separate agents (including when one component is on lower-cost tiers) reduces combo volume.
• Outcome shifting:
  • If prescribers increasingly choose SGLT2 + GLP-1 strategies, DPP-4 usage shrinks even absent generic competition.

How does STEGLUJAN compare with other diabetes regimens on formulary and outcomes?

Quick answer: STEGLUJAN’s incremental value depends on whether it is the lowest net-cost way to achieve both glycemic control and access. In many payer models, SGLT2 alone plus later escalation is easier to justify than maintaining a DPP-4-containing regimen.

Class-level outcome orientation

• SGLT2 inhibitors align to cardiorenal outcomes, making them structurally advantaged in payer decision-making.
• DPP-4 inhibitors provide glucose-lowering with limited outcome drivers relative to newer classes, which often compresses their negotiating leverage.

Implication for payer placement

• STEGLUJAN can be disadvantaged when:
  • The payer prefers SGLT2 inhibitors for outcomes and cheaper net costs,
  • GLP-1 agents are available with strong rebate support,
  • DPP-4 add-ons are restricted to narrow criteria.

What does STEGLUJAN pricing and contracting typically look like in the US?

Quick answer: Like most branded diabetes drugs, STEGLUJAN’s realized net price depends on rebate structures, patient assistance programs, and formulary tiering. Fixed-dose combos tend to face pressure to match or beat the effective cost of separate components.

Commercial mechanism affecting net sales

• Rebate aggressiveness:
  • Manufacturers often discount to defend access against preferred-agent controls.
• Tier placement:
  • Moves between preferred and non-preferred tiers can cause abrupt demand shifts.

Volume-to-sales sensitivity

• Because fixed-dose combos are used in specific titration sequences, small changes in access can have outsized effects on volume.

How does STEGLUJAN risk change under biosimilar or biologic dynamics?

Quick answer: Biosimilar dynamics do not directly affect STEGLUJAN because it is a small molecule, not a biologic. The relevant “biologic-like” risk analogue is simply class-level switching to other therapeutic modalities, particularly GLP-1 receptor agonists and related incretin therapies.

What commercial lessons can be mapped from other fixed-dose combos in diabetes?

Quick answer: Diabetes fixed-dose combinations commonly underperform when:

• Either component becomes cheaper or preferred in isolation,
• Guidelines and payer policies shift toward alternative intensification classes,
• Fixed-dose convenience is outweighed by cost.

Repeatable dynamics

• Combination advantage declines as the market matures and composes:
  • Generic availability of one or both components (not necessarily the combo),
  • Stronger formulary preference for class leaders.

Key takeaways

• STEGLUJAN’s market dynamics are driven less by unique clinical positioning and more by payer economics and evolving treatment algorithms that favor SGLT2 and GLP-1 over DPP-4.
• The commercial trajectory is vulnerable to formulary substitution toward separate components and to fixed-dose pricing pressure.
• Revenue-risk inflection depends on the timing of combination and component exclusivity loss and on continued class-switching to SGLT2/GLP-1 pathways, but specific patent and exclusivity dates are not available in the provided dataset.

FAQs

1. What payer restrictions most commonly limit STEGLUJAN uptake?
   Coverage that requires step therapy through metformin and/or preferred SGLT2 agents, plus restrictions where DPP-4 add-ons are placed on higher tiers.

2. Does STEGLUJAN outperform using separate ertugliflozin and sitagliptin tablets in payer economics?
   Often not, because payers can lower effective cost via separate component contracting and preferred-agent NDCs.

3. What clinical shifts most reduce demand for DPP-4-containing combinations like STEGLUJAN?
   Increased use of GLP-1 receptor agonists and preference for SGLT2-centric intensification sequences.

4. How quickly can STEGLUJAN lose market share after formulary tier changes?
   Demand can drop sharply within quarters due to prescription behavior changes once copays and prior authorization requirements tighten.

5. What are the most likely post-generic scenarios for STEGLUJAN sales?
   Pricing compression followed by migration to the lowest-net-cost fixed-dose option or to separate components, depending on rebate structures and formulary placement.

References

1. (No citable sources were provided in the prompt dataset.)

DrugChatter Q&A for STEGLUJAN

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