Last updated: September 2, 2026
Ertugliflozin and sitagliptin phosphate are marketed together in the United States as Steglujan, a fixed-dose combination for adults with type 2 diabetes. The product combines an SGLT2 inhibitor with a DPP-4 inhibitor. Its commercial opportunity has been constrained by intense SGLT2 competition, declining preference for DPP-4 inhibitors in patients with cardiovascular or renal risk, limited product-level revenue disclosure, and impending generic pressure on sitagliptin-based products.
Steglujan remains commercially relevant as an oral combination for glycemic control, but its growth profile is weaker than products built around the leading SGLT2 inhibitors empagliflozin and dapagliflozin.
What is Steglujan and who markets ertugliflozin with sitagliptin?
Steglujan contains ertugliflozin and sitagliptin phosphate. Merck and Pfizer jointly developed and commercialized the ertugliflozin franchise, which also includes Steglatro, a single-agent ertugliflozin product, and Segluromet, the ertugliflozin-metformin combination.
| Attribute |
Product detail |
| Brand |
Steglujan |
| Active ingredients |
Ertugliflozin and sitagliptin phosphate |
| Therapeutic area |
Type 2 diabetes |
| FDA approval |
December 2017 |
| Dosage form |
Once-daily oral tablet |
| Available strengths |
5 mg/100 mg and 15 mg/100 mg |
| Primary mechanism |
SGLT2 inhibition plus DPP-4 inhibition |
| Commercial partners |
Merck and Pfizer |
| Not indicated for |
Type 1 diabetes or treatment of diabetic ketoacidosis |
The FDA approved Steglujan as an adjunct to diet and exercise for adults with type 2 diabetes who require treatment with both ertugliflozin and sitagliptin or who are inadequately controlled on either agent alone. The label includes renal-function restrictions and warnings relating to ketoacidosis, volume depletion, genital mycotic infections, urinary tract infections, hypoglycemia when used with insulin or sulfonylureas, and pancreatitis risk associated with sitagliptin-containing therapy. [1]
How large is the market for ertugliflozin and sitagliptin?
The addressable market is large, but Steglujan competes in two mature and uneven segments.
SGLT2 inhibitors have expanded beyond glucose lowering because empagliflozin and dapagliflozin have demonstrated benefits in heart failure and chronic kidney disease. DPP-4 inhibitors remain useful for patients requiring a generally weight-neutral, low-hypoglycemia oral option, but they have weaker cardiovascular and renal differentiation.
SGLT2 market dynamics
The SGLT2 class is led by:
- Jardiance, containing empagliflozin, marketed by Boehringer Ingelheim and Eli Lilly.
- Farxiga, containing dapagliflozin, marketed by AstraZeneca.
- Invokana, containing canagliflozin, marketed by Johnson & Johnson.
- Steglatro, containing ertugliflozin, marketed by Merck and Pfizer.
Jardiance and Farxiga benefit from broad heart-failure and chronic-kidney-disease indications. Ertugliflozin has a narrower differentiation profile. The VERTIS CV cardiovascular-outcomes trial showed noninferiority for major adverse cardiovascular events but did not establish the same breadth of cardiovascular and renal positioning associated with Jardiance and Farxiga. [2]
DPP-4 market dynamics
Sitagliptin is the active ingredient in Januvia and a component of Janumet. The DPP-4 category includes:
- Sitagliptin
- Saxagliptin
- Linagliptin
- Alogliptin
DPP-4 products face pressure from GLP-1 receptor agonists, dual GIP/GLP-1 products, insulin, and SGLT2 inhibitors. Treatment guidelines increasingly prioritize GLP-1 receptor agonists or SGLT2 inhibitors for patients with atherosclerotic cardiovascular disease, heart failure, chronic kidney disease, obesity, or high cardiovascular risk. [3]
Steglujan therefore depends primarily on patients who need additional glycemic control but do not require, cannot access, or do not tolerate injectable or higher-cost incretin therapies.
How has the financial trajectory developed?
Steglujan revenue is not separately disclosed in the public financial statements of Merck or Pfizer. Both companies report the product within broader collaboration or diabetes portfolios. Product-level sales therefore cannot be isolated reliably from company filings.
The more useful financial indicators are the performance of the broader Januvia franchise, the ertugliflozin franchise, and the competitive SGLT2 market.
| Period |
Financial and commercial development |
| 2017 |
FDA approval of Steglujan |
| 2018-2019 |
Commercial launch with limited differentiation against established SGLT2 and DPP-4 brands |
| 2020-2022 |
SGLT2 market growth continued, but Steglujan remained a smaller product within the class |
| 2023-2024 |
Sitagliptin franchise faced increasing U.S. pricing and generic pressure; SGLT2 growth concentrated in Jardiance and Farxiga |
| 2025 onward |
Expected erosion risk from sitagliptin generics and continued payer scrutiny of branded combination products |
Merck’s Januvia franchise generated several billion dollars annually before patent and pricing pressure intensified. Those sales reflect Januvia, Janumet, and related sitagliptin products, not Steglujan alone. Steglujan is unlikely to represent a material share of that franchise because its commercial positioning is limited to a fixed SGLT2-DPP-4 combination.
Pfizer and Merck also do not present Steglujan as a major standalone revenue driver. The product is strategically important as part of the ertugliflozin collaboration, but it has not reached the commercial scale of leading SGLT2 brands.
What factors are limiting Steglujan sales growth?
Four factors explain the product’s restrained trajectory.
Limited outcomes differentiation
Ertugliflozin has not matched the breadth of outcome-based marketing available to empagliflozin and dapagliflozin. This affects prescribing in patients with heart failure or chronic kidney disease, where treatment selection increasingly follows organ-protection data rather than glucose-lowering efficacy alone.
Combination-product substitution
Physicians can prescribe an SGLT2 inhibitor and a DPP-4 inhibitor separately. That approach allows dose adjustment, formulary substitution, and selection of competing molecules. A fixed-dose combination is most attractive when it delivers a meaningful adherence or cost benefit.
Payer and formulary pressure
Steglujan competes against lower-cost generic sitagliptin, generic metformin combinations, and preferred branded SGLT2 products. Formularies may require failure on metformin, a preferred SGLT2 inhibitor, or a preferred DPP-4 product before covering Steglujan.
Therapeutic migration
Patients with obesity or high cardiovascular risk are increasingly treated with GLP-1 receptor agonists or tirzepatide. That migration reduces the pool of patients for whom a sitagliptin-containing combination is the preferred escalation strategy.
When does ertugliflozin and sitagliptin lose exclusivity?
The exclusivity analysis is split between the two active ingredients and the fixed-dose combination.
Sitagliptin exclusivity
Sitagliptin’s original U.S. composition-of-matter protection reached the end of its primary patent term in the early 2020s, with pediatric exclusivity affecting the final timing. Generic sitagliptin products have since created direct or indirect price pressure across Januvia, Janumet, and sitagliptin-containing combinations.
The commercial effect on Steglujan can occur even without a generic version of the exact fixed-dose combination. Physicians and payers can substitute separate generic sitagliptin and a preferred SGLT2 inhibitor.
Ertugliflozin exclusivity
Ertugliflozin has a later and more complex exclusivity profile than sitagliptin because protection depends on the underlying compound, formulation, combination, and regulatory patents. The core ertugliflozin franchise is exposed to generic entry later than sitagliptin, but the exact timing depends on Orange Book listings, patent challenges, and settlements.
Combination patents
Combination patents may cover:
- Ertugliflozin plus sitagliptin.
- Specific dose ratios.
- Pharmaceutical compositions.
- Methods of treating type 2 diabetes.
- Manufacturing or crystalline forms.
A generic applicant can challenge one or more listed patents through an abbreviated new drug application and a Paragraph IV certification. The absence of an exact Steglujan generic does not eliminate substitution risk because separate-component therapy may be clinically and economically adequate.
What is the Orange Book and Paragraph IV status of Steglujan?
The Orange Book is the principal FDA source for listed patents and regulatory exclusivity associated with approved drugs. Steglujan’s relevant protection must be assessed against the current Orange Book entries for the brand and against patents listed for the related ertugliflozin products.
A Paragraph IV certification alleges that a listed patent is invalid, unenforceable, or will not be infringed. If the brand holder files an infringement action within the statutory period, FDA approval of the generic may be delayed by a 30-month stay, subject to court decisions and statutory exceptions. [4]
The key commercial distinction is between:
- A direct Steglujan ANDA challenge.
- A challenge to Steglatro or Segluromet patents.
- Generic sitagliptin substitution.
- Physician substitution to Jardiance, Farxiga, or another preferred SGLT2 product.
Publicly available company disclosures do not identify Steglujan as the subject of a major litigated Paragraph IV dispute comparable to the high-profile patent cases involving leading SGLT2 or GLP-1 products.
What regulatory status and clinical limitations affect the product?
Steglujan has FDA approval for adults with type 2 diabetes, but the label does not provide a broad cardiovascular or renal-risk-reduction claim for the combination itself. Its use is limited by renal function and the safety profile of both components.
Ertugliflozin-related risks include:
- Ketoacidosis, including cases with relatively modest blood-glucose elevation.
- Genital fungal infections.
- Volume depletion and hypotension.
- Urinary tract infections.
- Lower-limb amputation concern based on the broader SGLT2 class history, although the risk profile is molecule- and population-dependent.
Sitagliptin-related risks include:
- Pancreatitis.
- Severe joint pain.
- Bullous pemphigoid.
- Hypersensitivity reactions.
- Dose adjustment requirements in renal impairment.
The product’s once-daily oral format is commercially useful, but the label limitations reduce its attractiveness for patients with advanced kidney disease or a strong need for proven organ-protection benefits.
How does Steglujan compare with competing diabetes products?
| Product |
Components |
Principal commercial strength |
Main threat to Steglujan |
| Steglujan |
Ertugliflozin/sitagliptin |
Single-tablet dual oral therapy |
Limited outcomes differentiation |
| Glyxambi |
Empagliflozin/linagliptin |
Stronger SGLT2 brand and cardiovascular positioning |
Direct branded combination competitor |
| Trijardy XR |
Empagliflozin/linagliptin/metformin |
Three-drug therapy and Jardiance franchise strength |
Greater regimen consolidation |
| Qtern |
Dapagliflozin/saxagliptin |
Farxiga franchise and broad SGLT2 positioning |
Payer and clinical preference |
| Janumet |
Sitagliptin/metformin |
Established sitagliptin franchise |
Generic sitagliptin and metformin pressure |
| Jardiance |
Empagliflozin |
Cardiovascular and renal indications |
Preferred SGLT2 substitution |
| Farxiga |
Dapagliflozin |
Heart failure and chronic kidney disease positioning |
Preferred SGLT2 substitution |
Steglujan’s closest strategic competitor is not only another fixed-dose combination. It is also the separate prescription of a preferred SGLT2 inhibitor plus generic sitagliptin.
What generic entry risks exist for Steglujan?
Generic entry risk is high for the sitagliptin component and moderate for the exact ertugliflozin combination, depending on patent status and litigation outcomes.
The most likely sequence is:
- Generic sitagliptin reduces the cost of the DPP-4 component.
- Payers favor separate generic sitagliptin plus a preferred SGLT2 inhibitor.
- Brand Steglujan faces formulary downgrades.
- Direct fixed-dose combination ANDAs emerge when remaining patents permit approval.
- Net pricing declines faster than prescription volume.
A generic launch could follow several scenarios:
| Scenario |
Commercial effect |
| Generic sitagliptin only |
Moderate indirect pressure on Steglujan |
| Generic ertugliflozin only |
Direct pressure on the SGLT2 component |
| Generic Steglujan before full patent expiry |
Rapid price erosion if litigation fails |
| At-risk launch after Paragraph IV litigation |
Potential damages exposure and accelerated market disruption |
| No direct generic for several years |
Continued gradual decline from therapeutic substitution |
Is there biosimilar risk for ertugliflozin and sitagliptin?
No. Steglujan is a small-molecule drug, so the relevant competitors are generic drugs filed through the ANDA pathway, not biosimilars filed under the Biologics Price Competition and Innovation Act.
The principal manufacturing barriers are conventional small-molecule controls, including active pharmaceutical ingredient purity, polymorphic form, dissolution, stability, bioequivalence, and tablet manufacturing. These barriers are meaningful for regulatory approval but are unlikely to support durable commercial pricing once multiple generic manufacturers enter.
What licensing deals affect the ertugliflozin franchise?
Merck and Pfizer formed a global collaboration to develop and commercialize ertugliflozin and related products. The collaboration covers Steglatro, Segluromet, and Steglujan. The companies share responsibilities and economics under the alliance, while product-level financial reporting remains limited.
The collaboration structure creates two commercial constraints:
- Neither company controls the entire product economics independently.
- Public filings do not provide a transparent standalone revenue or margin history for Steglujan.
The deal remains strategically relevant for portfolio participation, but the franchise has not produced the scale associated with the largest diabetes collaborations.
What geographic markets are most exposed?
The United States is the most important market for pricing, patent, and generic-entry analysis. U.S. exposure is heightened by:
- Pharmacy-benefit-manager rebates.
- Medicare Part D utilization.
- Generic substitution.
- Patent litigation under the Hatch-Waxman Act.
- The Medicare Drug Price Negotiation Program’s impact on sitagliptin-containing products.
Outside the United States, market dynamics vary by country. European markets generally apply tighter health-technology assessment and reference pricing. Japan and other Asian markets have different reimbursement rules and may place greater emphasis on combination-product convenience, but the same global competition from Jardiance and Farxiga remains.
Key Takeaways
- Steglujan is a fixed-dose ertugliflozin-sitagliptin product approved by the FDA in 2017.
- Product-level revenue is not separately disclosed by Merck or Pfizer.
- The broader sitagliptin franchise has faced major loss-of-exclusivity and pricing pressure.
- Ertugliflozin has weaker commercial differentiation than empagliflozin and dapagliflozin in cardiovascular and renal markets.
- The largest near-term threat is substitution with generic sitagliptin plus a preferred SGLT2 inhibitor.
- Steglujan has generic risk, not biosimilar risk.
- Combination and formulation patents may delay direct generic entry, but they do not prevent therapeutic substitution.
- Financial performance is likely to trend downward unless the product secures stronger formulary access or a meaningful adherence advantage.
FAQs
Is Steglujan more effective than Januvia alone?
Steglujan generally provides greater glucose-lowering potential than sitagliptin alone because it combines sitagliptin with ertugliflozin. The tradeoff is a broader adverse-effect profile and additional renal and volume-depletion considerations.
Can patients take generic sitagliptin and ertugliflozin instead of Steglujan?
Separate-component treatment may be clinically possible when the dosages and patient characteristics are appropriate. Substitution requires prescribing and formulary review because generic sitagliptin availability does not automatically establish equivalence to the fixed-dose product.
Does Steglujan have cardiovascular approval?
Steglujan is approved for glycemic control in type 2 diabetes. Its approval is not equivalent to a broad cardiovascular or renal-risk-reduction indication based on a dedicated outcomes trial for the combination.
Which drug is the strongest commercial competitor to Steglujan?
Jardiance is the strongest commercial competitor because empagliflozin has broad cardiovascular and renal positioning. Farxiga is also a major competitor, particularly in heart failure and chronic kidney disease.
What is the long-term investment outlook for Steglujan?
The long-term outlook is one of declining pricing power and limited revenue growth. The product may retain a niche among patients seeking once-daily oral dual therapy, but generic sitagliptin, preferred SGLT2 brands, and GLP-1-based therapies are likely to limit expansion.
References
-
U.S. Food and Drug Administration. (2017). Steglujan prescribing information. FDA.
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Cosentino, F., Cannon, C. P., Cherney, D. Z. I., Masiukiewicz, U., Pratley, R., Dagogo-Jack, S., Mancuso, J. P., Shih, W. J., O’Neill, E. A., Soliman, E. Z., & VERTIS CV Investigators. (2020). Efficacy and safety of ertugliflozin in patients with type 2 diabetes and established atherosclerotic cardiovascular disease. The Lancet, 396(10257), 1253-1264.
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American Diabetes Association Professional Practice Committee. (2024). 9. Pharmacologic approaches to glycemic treatment: Standards of care in diabetes. Diabetes Care, 47(Supplement 1).
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U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
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Merck & Co., Inc. (2024). 2023 annual report. Merck.
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Pfizer Inc. (2024). 2023 annual report. Pfizer.
