Ertugliflozin; sitagliptin phosphate - Generic Drug Details

What are the generic sources for ertugliflozin; sitagliptin phosphate and what is the scope of patent protection?

Ertugliflozin; sitagliptin phosphate is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin; sitagliptin phosphate has one hundred and thirty-nine patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for ertugliflozin; sitagliptin phosphate

International Patents:	139
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ertugliflozin; sitagliptin phosphate
DailyMed Link:	ertugliflozin; sitagliptin phosphate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ertugliflozin; sitagliptin phosphate

Constraining patent/regulatory exclusivity:

9,308,204

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 ertugliflozin; sitagliptin phosphate

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

Anatomical Therapeutic Chemical (ATC) Classes for ertugliflozin; sitagliptin phosphate

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ertugliflozin; sitagliptin phosphate

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	209805-002	Dec 19, 2017		RX	Yes	Yes	7,326,708*PED				Y
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	9,308,204		Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes	8,080,580		Y	Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes	9,439,901

Expired US Patents for ertugliflozin; sitagliptin phosphate

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	7,078,381
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	7,459,428
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	7,459,428
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017	7,078,381

International Patents for ertugliflozin; sitagliptin phosphate

Country	Patent Number	Title	Estimated Expiration
Taiwan	I347185
Croatia	P20150107
Malaysia	155418
South Korea	20130116078
South Korea	101446454
Colombia	5660266	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV

Supplementary Protection Certificates for ertugliflozin; sitagliptin phosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	132018000000441	Italy		PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323
2334687	C02334687/01	Switzerland		FORMER OWNER: PFIZER INC., US
2334687	CR 2018 00025	Denmark		PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323
2334687	C20180023 00266	Estonia		PRODUCT NAME: ERTUGLIFLOSIIN;REG NO/DATE: EU/1/18/1267 23.03.2018
2334687	122018000070	Germany		PRODUCT NAME: ERTUGLIFLOZIN, EINSCHLIESSLICH KRISTALL UMFASSEND ERTUGLIFLOZIN UND ERTUGLIFLOZIN UND L-PYROGLUTAMINSAEURE ALS CO-KRISTALL; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687	SPC/GB18/026	United Kingdom		PRODUCT NAME: ERTUGLIFOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFOZIN L-PYROGLUTAMIC ACID; REGISTERED: UK EU/1/18/1267/001(NI) 20180321; UK EU/1/18/1267/002(NI) 20180321; UK EU/1/18/1267/003(NI) 20180321; UK EU/1/18/1267/004(NI) 20180321; UK EU/1/18/1267/005(NI) 20180321; UK EU/1/18/1267/006(NI) 20180321; UK PLGB 53095/0064 20180321; UK PLGB 53095/0065 20180321; UK EU/1/18/1267/007(NI) 20180321; UK EU/1/18/1267/008(NI) 20180321; UK EU/1/18/1267/009(NI) 20180321; UK EU/1/18/1267/010(NI) 20180321; UK EU/1/18/1267/011(NI) 20180321; UK EU/1/18/1267/012(NI) 20180321

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Ertugliflozin and Sitagliptin Phosphate

Last updated: July 28, 2025

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Introduction

The global pharmaceutical landscape for type 2 diabetes mellitus (T2DM) therapeutics remains highly competitive, driven by escalating prevalence, regulatory advances, and emerging treatment paradigms. Two prominent agents in this space are Ertugliflozin, a novel SGLT2 inhibitor, and Sitagliptin Phosphate, a well-established DPP-4 inhibitor. Their market trajectories reflect evolving clinical preferences, regulatory developments, and strategic positioning by pharmaceutical companies seeking sustained revenue streams amid shifting healthcare policies.

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Market Overview and Epidemiological Context

T2DM affects approximately 462 million individuals worldwide, a number projected to rise to 700 million by 2045 [1]. The chronic nature of the disease and its associated complications—cardiovascular, renal, and neurological—generate persistent demand for effective therapeutics. As first-line treatments such as metformin encounter limitations owing to efficacy waning and tolerability issues, clinicians increasingly turn towards adjuncts like SGLT2 inhibitors and DPP-4 inhibitors, including ertugliflozin and sitagliptin.

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Ertugliflozin: Market Dynamics and Financial Outlook

Regulatory Pathway and Market Entry
Ertugliflozin was developed by Pfizer and approved by the FDA in December 2017 under the brand name Steglatro. As a selective SGLT2 inhibitor, it offers a unique mechanism by promoting glucosuria, thereby reducing hyperglycemia with added benefits of weight loss and blood pressure reduction.

Market Performance and Adoption
Despite Pfizer's robust marketing efforts, ertugliflozin’s market penetration remains modest compared to pioneering agents like empagliflozin (Jardiance) and dapagliflozin (Farxiga). Factors influencing its constrained growth include late market entry relative to competitors, limited clinical differentiation, and prescriber inertia favoring established brands.

Financial Projections
Analysts estimate that the global SGLT2 inhibitor market, valued at approximately $9 billion in 2022, will grow at a Compound Annual Growth Rate (CAGR) of 12% through 2027 [2]. Ertugliflozin is projected to secure a niche within this expanding market segment, with sales reaching an estimated $300-500 million by 2027. Market adoption benefits from shifting guidelines endorsing SGLT2 inhibitors for cardiovascular and renal protection beyond glycemic control, as demonstrated in the DAPA-CKD and EMPA-REG OUTCOME trials [3][4].

Competitive Positioning
Ertugliflozin’s financial trajectory hinges on strategic differentiation, such as positioning for particular patient subsets or combinations with other agents, and leveraging formulary approvals. Its later entry diminishes its standalone revenue potential but may support uptake via combination therapy pipelines or specific clinical niches.

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Sitagliptin Phosphate: Market Dynamics and Financial Trajectory

Regulatory and Clinical Landscape
Sitagliptin was developed by Merck and was one of the first DPP-4 inhibitors introduced into the market in 2006. Its well-established safety profile and convenient oral dosing have secured it as a mainstay in T2DM treatment, especially for patients requiring monotherapy or combination with metformin.

Market Penetration and Competition
Sitagliptin's market dominance endured due to its early approval, extensive clinical data, and high physician familiarity. However, recent years have seen competitive erosion from newer agents with demonstrated cardiovascular or weight-loss benefits, such as oral semaglutide and combination therapies like SGLT2 inhibitors plus DPP-4 inhibitors.

Financial Forecasts and Revenue Trends
Merck’s global sales of sitagliptin (brand: Januvia) peaked at over $5 billion in 2014 but have since plateaued or declined slightly, reflecting increased generic competition post-patent expiration in 2017. Still, the drug maintains a substantial revenue base in emerging markets and combination formulations. The overall DPP-4 inhibitor market is projected to grow at approximately 4% CAGR through 2028, reaching ~$4 billion globally [5].

Future Outlook
Sitagliptin’s trajectory will likely depend on its integration into combination products and its positioning amidst the expanding landscape of incretin-based therapies. Monetization could pivot from monotherapy revenues to royalties and co-marketing agreements for fixed-dose combinations.

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Factors Influencing Market Dynamics

1. Regulatory Approvals and Labeling
   The FDA’s recent approvals of cardiovascular and renal protective indications for SGLT2 inhibitors (including empagliflozin and dapagliflozin) elevate the entire class, indirectly benefitting ertugliflozin. Conversely, sitagliptin's safety concerns—particularly regarding pancreatitis—may temper growth prospects.

2. Pricing and Reimbursement Policies
   Price inflation pressures and the increasing emphasis on biosimilars/generics influence revenue streams. For sitagliptin, generic competition has driven a significant decline in prices, restricting profit margins. Ertugliflozin, still branded, benefits from higher price points but faces challenges from generics upon patent expiration.

3. Clinical Trial Data and Real-World Evidence
   Evidence supporting cardiovascular and renal benefits increases trust and adoption for SGLT2 inhibitors. Meanwhile, ongoing studies evaluating combination therapies and long-term safety will shape future market trends.

4. Healthcare Policy and Market Access
   Expanding coverage for claims related to cardiovascular benefits and renal protection could accelerate uptake of both drugs, especially if supported by key payers and health authorities.

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Strategic Implications and Investment Considerations

Early-stage drug developers must recognize the importance of differentiation in a crowded T2DM market. For ertugliflozin, emphasizing niche indications, combination therapy development, and post-marketing studies can facilitate growth. For sitagliptin, maintaining market share through strategic alliances, cost management, and positioning within combination regimens remains crucial.

Pharmaceutical companies should also monitor patent landscapes vigilantly, as impending generics or biosimilars significantly impact revenue forecasts. Additionally, aligning with evolving clinical evidence that underscores cardiovascular and renal protective benefits will be pivotal in sustaining market relevance.

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Key Takeaways

• Ertugliflozin’s market potential remains constrained by late entry and stiff competition but benefits from class-wide shifts toward cardiovascular and renal protection due to recent trial results.

• Sales forecasts suggest ertugliflozin could reach $300-500 million globally by 2027, primarily through niche positioning and combination therapies.

• Sitagliptin continues to generate substantial revenue but faces significant headwinds from patent expiry and competition from newer agents, with forecasts indicating gradual decline or plateauing sales.

• Market dynamics are heavily influenced by regulatory approvals, clinical trial outcomes, pricing strategies, and healthcare policies emphasizing comprehensive diabetic care.

• Strategic differentiation, clinical validation, and integration into combination regimens are critical to sustaining profitability for both agents.

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FAQs

Q1: How do ertugliflozin and sitagliptin compare in terms of efficacy for glycemic control?
Ertugliflozin, as an SGLT2 inhibitor, reduces blood glucose by promoting urinary glucose excretion and offers added benefits like weight loss and cardiovascular risk reduction. Sitagliptin, a DPP-4 inhibitor, enhances endogenous incretin levels, leading to increased insulin secretion and decreased glucagon, effectively lowering blood glucose with a favorable safety profile.

Q2: What are the key safety considerations for each drug?
Ertugliflozin carries risks of urinary tract infections, genital mycotic infections, and rare cases of diabetic ketoacidosis. Sitagliptin has been associated with pancreatitis and, in rare cases, joint pain and hypersensitivity reactions. Cardiovascular safety profiles for both are generally favorable, especially post-approval updates.

Q3: How will patent expiration influence the future sales of sitagliptin?
Post-patent expiration in 2017, generic versions significantly reduced prices, leading to a decline in branded sales. Future revenues will increasingly depend on market share retention, combination formulations, and geographic expansion.

Q4: Are combination therapies more promising for oral anti-diabetic agents?
Yes. Combining agents with complementary mechanisms can improve adherence, optimize glycemic control, and reduce side effects. Both ertugliflozin and sitagliptin are available in fixed-dose combinations, which are gaining favor in clinical practice.

Q5: What is the outlook for the broader SGLT2 and DPP-4 inhibitor classes?
The SGLT2 class is poised for continued growth driven by cardiovascular and renal indications and expanding approvals. DPP-4 inhibitors will likely stabilize or decline in market share unless new indications or combination therapies demonstrate additional benefits.

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Sources

1. International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.
2. MarketWatch. “Global SGLT2 Inhibitors Market Size & Share Analysis,” 2022.
3. Zinman B et al. “Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes,” NEJM, 2015.
4. Heerspink HJ et al. “Dapagliflozin in Patients with Chronic Kidney Disease,” NEJM, 2020.
5. Grand View Research. “DPP-4 inhibitors Market Size, Share & Trends Analysis,” 2022.

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In conclusion, understanding the evolving market dynamics of ertugliflozin and sitagliptin phosphate enables strategic decision-making amidst a highly competitive and innovation-driven landscape. Continuous evaluation of regulatory developments, clinical evidence, and competitive positioning remains paramount for stakeholders aiming to optimize financial outcomes.