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	209805-001	Dec 19, 2017		RX	Yes	No	7,326,708*PED				Y

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	209805-001	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	209805-002	Dec 19, 2017	7,459,428

International Patents for ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Montenegro	00405	So fosforne kiseline i inhibitora dipeptidil peptidaze-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
Eurasian Patent Organization	201290267	ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА
Dominican Republic	P2004000941	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	392 18-2018	Slovakia		PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 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

Market dynamics and financial trajectory for ertugliflozin and sitagliptin phosphate

Last updated: February 13, 2026

Ertugliflozin: Market size and growth trajectory

Ertugliflozin, marketed as Steglatro by Pfizer, was approved by the FDA in December 2017 for type 2 diabetes management. It is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. The drug's revenue depends on its adoption within the SGLT2 class, which has gained prominence due to cardiovascular and renal benefits.

The global SGLT2 inhibitor market was valued at approximately $11.6 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 20% through 2027, driven by increasing diabetes prevalence, expanding indications, and expanding regional markets[1].

Pfizer's market share for ertugliflozin was approximately 5% in 2022, with sales around $500 million. The drug's annual revenue has been steadily increasing, with a mid-single-digit growth rate expected over the next five years, assuming continued clinical acceptance and inclusion in treatment guidelines.

Key factors influencing future revenue:

• The inclusion of ertugliflozin in clinical guidelines for diabetes and diabetic kidney disease.
• Competitive landscape, primarily SGLT2 inhibitors like Jardiance (Empagliflozin), Invokana (Canagliflozin), and Farxiga (Dapagliflozin).
• Patent expirations: Pfizer's patent for ertugliflozin expires in 2030, opening potential for biosimilar or generic competition.

Sitagliptin phosphate: Market size and growth trajectory

Sitagliptin, marketed as Januvia by Merck, entered the market in 2006 as a dipeptidyl peptidase-4 (DPP-4) inhibitor. It has historically maintained a leading position in oral anti-diabetes therapies.

The global DPP-4 inhibitor market was valued at $4.5 billion in 2021. It is forecast to grow at a CAGR of 8% to 9% through 2027, driven by broader adoption and combination therapy preferences[2].

Januvia generated approximately $4.2 billion in revenue in 2022. While growth has slowed post-2018 due to market saturation, it remains a substantial revenue contributor to Merck. The primary factors affecting future financial performance include:

• Patent expiry in key markets: Merck's exclusivity in the US ends in 2024+.
• Competition from newer agents like GLP-1 receptor agonists and SGLT2 inhibitors.
• The rise of combination products, integrating sitagliptin with metformin or other drugs to maintain market position.

Competitive landscape and R&D investments

Both drugs face intense competition:

• For ertugliflozin: Most sales are within an established class dominated by Jardiance and Farxiga.
• For sitagliptin: Generic competition is imminent, with multiple biosimilar versions expected post-2024.

Pfizer and Merck's R&D budgets for diabetes treatments are directed toward expanding indications, improving drug delivery, and exploring fixed-dose combinations to extend product lifecycle.

Regulatory and patent considerations

Patent protections influence revenue longevity. Ertugliflozin's patent expiration in 2030 allows for biosimilar introduction in subsequent years. Sitagliptin's primary patent has a similar expiration, with generic versions available from 2024, decreasing revenue.

Regulatory agencies are increasingly focusing on cardiovascular and renal outcomes, which influence label expansions and market access.

Financial projections

Drug	2022 Revenue	Predicted 2027 Revenue	CAGR (2022-2027)	Key Risks
Ertugliflozin	$500 million	~$860 million	~11%	Patent expiry, competition
Sitagliptin	$4.2 billion	~$3.8 billion	~-2%	Patent expiry, biosimilar entry

Summary assessment

Ertugliflozin is expected to grow modestly over the next five years, contingent on clinical guideline acceptance and competitive pressures. Sitagliptin's revenue will decline post-patent expiry, with the market shifting toward combination therapies and newer agents.

Key takeaways

• The global SGLT2 market is expanding rapidly, with ertugliflozin holding a small but growing share.
• Sitagliptin remains a high-revenue asset but faces patent cliffs and intensified competition.
• Patent expiries will significantly influence future revenues for both drugs.
• R&D investments are focused on expanding indications and combination therapies to extend market relevance.
• Market dynamics are shaped by regulatory shifts emphasizing cardiovascular and renal outcomes.

FAQs

1. How does patent expiry impact ertugliflozin's market share?

Patent expiration in 2030 opens the market for biosimilars, potentially reducing prices and revenue.

2. What are the main competitors of sitagliptin?

Januvia faces competition from other DPP-4 inhibitors like linagliptin and alogliptin, as well as from GLP-1 receptor agonists and SGLT2 inhibitors.

3. Will ertugliflozin gain expanded indications?

Possible, depending on ongoing clinical trials demonstrating benefits for renal and cardiovascular outcomes, which can influence label updates.

4. How significant is the market shift toward combination therapies?

Major, as combining DPP-4 inhibitors with other antidiabetics offers enhanced efficacy, influencing sales strategies.

5. Can biosimilars affect the future revenues of sitagliptin?

Yes, biosimilars expected post-2024 will challenge Merck's market share and pricing power.

Citations

[1] Fortune Business Insights, "SGLT2 Inhibitors Market Size, Share & Industry Analysis," 2022.

[2] Grand View Research, "DPP-4 Inhibitors Market Size & Trends," 2022.