Last updated: September 5, 2026
Ertugliflozin is a once-daily SGLT2 inhibitor marketed in the U.S. as Steglatro, with sitagliptin as Steglujan and metformin as Segluromet. Pfizer and Merck developed the product through a global collaboration. FDA approval came in December 2017 for glycemic control in adults with type 2 diabetes.[1]
Ertugliflozin has remained a commercially minor SGLT2 inhibitor. Its market position has been constrained by the earlier launch and stronger cardiovascular, renal and heart-failure evidence associated with empagliflozin and dapagliflozin. Public filings do not provide a consistent, standalone annual revenue series for Steglatro, Steglujan or Segluromet. The product has generally been reported within broader alliance or diabetes-product categories rather than as a material individual brand.
What is ertugliflozin and how is it used?
Ertugliflozin selectively inhibits sodium-glucose cotransporter 2 in the renal proximal tubule. The mechanism increases urinary glucose excretion and lowers blood glucose independently of insulin secretion.
| Product |
Active ingredients |
U.S. dosage form |
Initial FDA approval |
| Steglatro |
Ertugliflozin |
5 mg and 15 mg tablets |
December 2017 |
| Steglujan |
Ertugliflozin and sitagliptin |
Fixed-dose tablets |
January 2018 |
| Segluromet |
Ertugliflozin and metformin hydrochloride |
Fixed-dose tablets |
May 2018 |
The FDA-approved indication is adjunctive diet and exercise treatment for glycemic control in adults with type 2 diabetes. The label does not establish a cardiovascular or renal risk-reduction indication comparable to the later label expansions for Jardiance or Farxiga.[1]
Ertugliflozin is not approved as a biosimilar product, and biosimilar competition is not relevant because it is a chemically synthesized small molecule. The principal future threat is conventional generic competition, including generic ertugliflozin tablets and potentially generic fixed-dose combinations.
How does ertugliflozin compare with Jardiance and Farxiga?
Ertugliflozin competes in the same SGLT2 inhibitor class as empagliflozin, dapagliflozin and canagliflozin. Its commercial disadvantage is the relative strength of competitor outcomes data and label breadth.
| Drug |
Brand |
Developer or principal marketer |
Major commercial differentiator |
| Ertugliflozin |
Steglatro |
Merck and Pfizer |
Glycemic-control SGLT2 product with limited cardiovascular-label reach |
| Empagliflozin |
Jardiance |
Boehringer Ingelheim and Eli Lilly |
Cardiovascular, heart-failure and chronic kidney disease indications |
| Dapagliflozin |
Farxiga |
AstraZeneca |
Heart failure and chronic kidney disease indications across diabetic and nondiabetic populations |
| Canagliflozin |
Invokana |
Johnson & Johnson, later commercialized by other parties |
Early SGLT2 market entry and renal outcomes positioning |
The VERTIS-CV trial showed that ertugliflozin was noninferior to placebo for major adverse cardiovascular events, but it did not demonstrate superiority on the primary endpoint.[2] The study did show reductions in hospitalization for heart failure and renal outcomes in selected analyses, but those results did not produce the same commercial repositioning achieved by Jardiance and Farxiga.
The result was a narrower value proposition. Payers and prescribers increasingly use SGLT2 inhibitors for heart failure and chronic kidney disease, not only glucose lowering. Ertugliflozin entered the class after those broader treatment patterns had already developed.
What is the financial trajectory of ertugliflozin?
Ertugliflozin has not become a major disclosed revenue contributor for either Pfizer or Merck.
Revenue visibility
Pfizer and Merck financial statements have generally grouped ertugliflozin-related income with broader collaboration, alliance or diabetes categories. Neither company has consistently reported annual global net sales for Steglatro as a separate material line item. This limits direct measurement of:
- Global brand revenue
- U.S. versus international sales
- Gross-to-net deductions
- Product-level operating margin
- Royalty allocation between Merck and Pfizer
Public evidence supports a conclusion of modest commercial scale rather than a large-brand trajectory. The product did not develop into a peer of Januvia, Jardiance or Farxiga in reported sales importance.
Commercial development path
The financial trajectory can be divided into four periods:
| Period |
Market event |
Financial effect |
| 2017-2018 |
Steglatro, Steglujan and Segluromet launches |
Initial uptake occurred in a crowded SGLT2 class |
| 2019-2020 |
Limited differentiation against Jardiance and Farxiga |
Prescribing remained constrained by outcomes evidence and formulary position |
| 2020-2022 |
VERTIS-CV results and broader SGLT2 use in heart failure and kidney disease |
Competitor label expansion increased relative pressure |
| 2023 onward |
Mature SGLT2 category and approaching generic risk |
Pricing power and long-term brand investment weakened |
The absence of a prominent standalone sales line is itself commercially relevant. It suggests that ertugliflozin has had limited leverage in portfolio negotiations, licensing economics and lifecycle investment compared with the leading SGLT2 brands.
What patents protect ertugliflozin products?
Ertugliflozin protection relies on a layered small-molecule patent estate rather than biologic exclusivity. The estate includes compound, crystalline-form, formulation and combination-product claims.
Publicly associated U.S. patent families include:
| Patent family or patent |
Subject matter |
Commercial relevance |
| U.S. Patent No. 7,405,198 |
Ertugliflozin-related C-aryl glucoside compounds |
Foundational active-ingredient protection |
| U.S. Patent No. 8,618,061 |
Later ertugliflozin chemical or solid-form subject matter |
Potential secondary protection |
| U.S. Patent No. 9,266,951 |
Additional compound, composition or use claims associated with ertugliflozin |
Potential later-term barrier |
| Combination-product patent families |
Ertugliflozin with sitagliptin or metformin |
Relevant to Steglujan and Segluromet |
Patent scope and expiration must be assessed claim by claim. A patent listed for a fixed-dose combination does not necessarily block an applicant seeking approval for single-ingredient ertugliflozin. Conversely, a formulation or solid-form patent can delay a product launch if the proposed generic relies on the protected form.
The earliest compound patent does not determine the entire market-entry date. Later patents, patent-term adjustment, patent-term extension and pediatric exclusivity can change effective protection. The commercially relevant question is the last enforceable claim covering the proposed generic product, not simply the oldest ertugliflozin patent.
When does ertugliflozin lose exclusivity?
Ertugliflozin's five-year new chemical entity exclusivity began with FDA approval in December 2017 and generally expired in December 2022.[1] That period barred an ANDA submission relying on the listed drug's approval before the expiration of NCE exclusivity, subject to statutory exceptions.
Patent-based protection extends beyond regulatory exclusivity. The relevant practical timeline is:
| Exclusivity layer |
Approximate status |
| New chemical entity exclusivity |
Expired in 2022 |
| Foundational compound protection |
Approaching or reaching the mid-2020s, depending on applicable term adjustments or extensions |
| Secondary chemical, solid-form and combination patents |
Potentially extending into the late 2020s or early 2030s |
| Pediatric exclusivity |
No broadly material extension should be assumed without confirmation in current FDA records |
The existence of later patents does not guarantee a valid blocking right. Generic applicants can challenge validity, enforceability and infringement, particularly where the asserted claims cover a narrow solid form, dosing regimen or combination.
What is the Orange Book status of Steglatro?
Steglatro, Steglujan and Segluromet are FDA-approved prescription products subject to Orange Book patent-listing rules. The Orange Book is the principal public source for listed patents and regulatory exclusivity associated with approved small-molecule products.[3]
The key Orange Book issues are:
- Whether a patent is listed against Steglatro, Steglujan or Segluromet separately.
- Whether the listed claim covers the active ingredient, formulation, method of use or combination.
- Whether the patent expiration date has been adjusted by patent-term extension or pediatric exclusivity.
- Whether a generic applicant can certify Paragraph IV against a listed patent.
- Whether the applicant can omit a patented use under a section viii statement.
Orange Book listing does not establish patent validity. It creates the framework for ANDA certification and the potential 30-month stay following timely patent litigation.
Which companies are challenging ertugliflozin patents?
No major, widely reported U.S. Paragraph IV litigation campaign has established a public generic challenge comparable to the disputes surrounding several blockbuster diabetes products. The absence of prominent litigation does not establish that no ANDA has been filed. ANDA filings and patent challenges may remain confidential until the reference sponsor brings an infringement action or the FDA publishes relevant approval information.
Potential challengers would include established generic manufacturers with diabetes portfolios, such as Teva, Sandoz, Viatris, Sun Pharma, Dr. Reddy's Laboratories and Torrent Pharmaceuticals. The commercial incentive depends on the remaining patent term, expected price erosion, market size and the ability to manufacture the relevant polymorph or formulation.
How would a Paragraph IV challenge affect entry?
A Paragraph IV certification alleging that a listed patent is invalid, unenforceable or not infringed can trigger patent litigation. If litigation is filed within the statutory period, FDA approval may be stayed for up to 30 months, subject to court developments and statutory exceptions.[4]
For ertugliflozin, a challenge to a compound patent would have greater commercial value than a challenge limited to a fixed-dose combination. A successful challenge to the core active-ingredient claim could open the single-agent market, while combination patents could continue to affect Steglujan or Segluromet separately.
What formulation and method-of-use patents protect ertugliflozin?
Ertugliflozin patent risk is likely to vary by dosage form.
Single-agent tablets
The primary issues are the active pharmaceutical ingredient, crystalline form, excipients, dissolution profile and manufacturing process. A generic applicant may avoid some formulation claims by using a different excipient system or non-infringing solid form, but bioequivalence requirements constrain design choices.
Steglujan
Steglujan combines ertugliflozin with sitagliptin. Combination patents may claim specific dose ratios, tablet compositions, treatment methods or pharmacokinetic characteristics. A generic applicant can target individual components rather than the fixed-dose combination, but that would not be an equivalent substitute for all prescribers or payers.
Segluromet
Segluromet combines ertugliflozin with metformin. Patent exposure can include immediate-release or extended-release compositions, dose combinations and methods of treating patients inadequately controlled on metformin.
Method-of-use patents are commercially weaker when physicians can prescribe the product for an unpatented indication or when the generic label can omit a patented use. Formulation and composition claims can be more difficult to avoid if they cover the marketed tablet broadly.
What generic launch risks exist for ertugliflozin?
Generic entry is likely to produce rapid price erosion if a manufacturer obtains approval without a launch-at-risk injunction. The main scenarios are:
| Launch scenario |
Likely market effect |
| No approved generic before late-decade patent expiration |
Continued low-to-moderate branded sales with limited pricing power |
| First generic enters after settlement or successful challenge |
Rapid share migration in price-sensitive formularies |
| Multiple ANDA approvals near patent expiry |
Steep net-price decline and limited residual brand value |
| Generic single agent only |
Pressure on Steglatro, with less direct effect on fixed-dose combinations |
| Generic single agent plus combinations |
Broad erosion across the ertugliflozin franchise |
Because the product is not a leading SGLT2 brand, the first generic may face a smaller absolute revenue pool than generic entrants targeting Jardiance or Farxiga. The lower base can reduce litigation incentives, but it can also make the branded product more vulnerable to formulary displacement.
What patent litigation and settlement issues affect ertugliflozin?
No widely disclosed settlement has defined a market-entry date for generic ertugliflozin comparable to high-profile settlements involving larger diabetes brands. Any future settlement would likely address:
- Earliest agreed generic launch date
- Whether the settlement covers Steglatro, Steglujan and Segluromet
- Authorized-generic rights
- Supply or licensing arrangements
- Treatment of later-filed patents
- Allocation of litigation costs and commercial territories
A settlement could preserve some brand revenue while permitting an earlier generic launch than the final patent expiration. The value of that tradeoff is limited by ertugliflozin's modest market scale and weak differentiation.
How strong is the ertugliflozin patent estate?
The estate is moderate rather than exceptionally strong.
Strengths include the layered protection around the active ingredient, solid forms and combination products. Weaknesses include the absence of biologic manufacturing complexity, the age of the foundational chemistry, limited commercial scale and the ability of generic applicants to pursue alternative formulations or label carve-outs.
| Factor |
Assessment |
| Core molecule |
Historically important, but aging |
| Secondary patents |
Potentially meaningful for specific products and forms |
| Regulatory exclusivity |
Expired |
| Formulation barriers |
Relevant but product-specific |
| Manufacturing barriers |
Manageable for experienced generic manufacturers |
| Litigation economics |
Lower than for blockbuster diabetes brands |
| Overall durability |
Moderate, with declining commercial value |
What is the competitive outlook for ertugliflozin?
Ertugliflozin is likely to remain a secondary SGLT2 product unless its owners obtain a new indication with clinically differentiated outcomes data. That path is commercially difficult because the class leaders already have broad heart-failure and renal positioning.
The major competitive pressures are:
- Jardiance and Farxiga's broader outcome-based prescribing
- Generic entry into other SGLT2 products
- Payer preference for products with cardiovascular and renal indications
- Combination competition from metformin and DPP-4 inhibitor products
- Declining willingness to pay for a diabetes-only SGLT2 product
- Limited public evidence of major new lifecycle investments
Key Takeaways
- Ertugliflozin is marketed as Steglatro, Steglujan and Segluromet.
- FDA approval occurred in December 2017; five-year NCE exclusivity expired in 2022.
- The product has not become a major separately reported revenue contributor for Pfizer or Merck.
- VERTIS-CV established cardiovascular noninferiority but did not produce superiority on the primary endpoint.
- Jardiance and Farxiga have stronger commercial positions because of broader cardiovascular, heart-failure and renal indications.
- Patent protection extends beyond NCE exclusivity through compound, solid-form, formulation and combination claims.
- Generic risk is conventional ANDA risk, not biosimilar risk.
- Publicly reported litigation and settlement activity has been limited compared with larger diabetes franchises.
- The patent estate is moderate, but the commercial value of remaining protection is constrained by weak market differentiation and limited brand scale.
FAQs
Is ertugliflozin being discontinued?
There is no basis to treat the entire ertugliflozin franchise as discontinued solely because it has limited sales. Steglatro, Steglujan and Segluromet remain FDA-approved products, although commercial availability can vary by country, wholesaler and manufacturer strategy.
Does ertugliflozin have a heart-failure indication?
Ertugliflozin does not have the same broad heart-failure labeling as dapagliflozin or empagliflozin. VERTIS-CV reported heart-failure and renal findings, but the U.S. label remains centered on glycemic control.[1][2]
Can a generic manufacturer launch ertugliflozin before all patents expire?
Potentially. A generic company can launch after a successful Paragraph IV challenge, a settlement-defined date, a finding of noninfringement or use of a label that omits patented indications. The outcome depends on the specific Orange Book claims and litigation.
Are Steglatro and Jardiance interchangeable?
They are in the same pharmacologic class but are not automatically interchangeable. Formulary status, renal function, approved indications, cardiovascular history, payer rules and prescriber judgment determine product selection.
Which ertugliflozin product faces the highest patent complexity?
Fixed-dose combinations, particularly Steglujan and Segluromet, can face more complex claim sets because they may involve combination, dose-ratio, formulation and method-of-use patents in addition to ertugliflozin active-ingredient protection.
References
-
U.S. Food and Drug Administration. (2017). Steglatro (ertugliflozin) prescribing information. FDA.
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Cannon, C. P., Pratley, R., Dagogo-Jack, S., Mancuso, J., Huyck, S., Masiukiewicz, U., Charbonnel, B., Frederich, R., Gallo, S., Cosentino, F., Shih, W. J., Gantz, I., Terra, S. G., & VERTIS CV Investigators. (2020). Cardiovascular outcomes with ertugliflozin in type 2 diabetes. New England Journal of Medicine, 383(15), 1425-1435.
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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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U.S. Code. (2024). 21 U.S.C. ยง 355(j): Abbreviated applications for new drugs. Congress.gov.
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Merck & Co., Inc. (2013-2024). Annual reports and financial filings. Merck.
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Pfizer Inc. (2013-2024). Annual reports and financial filings. Pfizer.
