ERTUGLIFLOZIN - Generic Drug Details

What are the generic drug sources for ertugliflozin and what is the scope of freedom to operate?

Ertugliflozin is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd V, Hikma, and Msd Sub Merck, and is included in six NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin has sixty-one patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for ERTUGLIFLOZIN

International Patents:	61
US Patents:	5
Tradenames:	4
Applicants:	4
NDAs:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	41
Patent Applications:	1,326
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERTUGLIFLOZIN
What excipients (inactive ingredients) are in ERTUGLIFLOZIN?	ERTUGLIFLOZIN excipients list
DailyMed Link:	ERTUGLIFLOZIN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERTUGLIFLOZIN

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.

Recent Clinical Trials for ERTUGLIFLOZIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1
Ain Shams University	Phase 2/Phase 3
Amsterdam UMC, location VUmc	PHASE4

See all ERTUGLIFLOZIN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ERTUGLIFLOZIN

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

Paragraph IV (Patent) Challenges for ERTUGLIFLOZIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STEGLATRO	Tablets	ertugliflozin	5 mg and 15 mg	209803	3	2021-12-20

US Patents and Regulatory Information for ERTUGLIFLOZIN

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	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No			Y
Aurobindo Pharma Ltd	ERTUGLIFLOZIN	ertugliflozin	TABLET;ORAL	216947-002	Jul 13, 2023		DISCN	No	No
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-001	Dec 19, 2017		RX	Yes	No			Y	Y
Hetero Labs Ltd V	ERTUGLIFLOZIN	ertugliflozin	TABLET;ORAL	217071-002	Sep 17, 2024		DISCN	No	No
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for ERTUGLIFLOZIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Steglatro	ertugliflozin	EMEA/H/C/004315Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.in addition to other medicinal products for the treatment of diabetes.	Authorised	no	no	no	2018-03-21

International Patents for ERTUGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	2728
Argentina	073138
Austria	E540040
Australia	2009286380
Brazil	PI0918841

Supplementary Protection Certificates for ERTUGLIFLOZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	201840022	Slovenia		PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; NATIONAL AUTHORISATION NUMBER: EU/1/18/1267/001-012; DATE OF NATIONAL AUTHORISATION: 20180321; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2334687	300943	Netherlands		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, MET NAME ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687	30/2018	Austria		PRODUCT NAME: ERTUGLIFLOZIN, GEGEBENENFALLS ALS KRISTALLFORM, INSBESONDERE ALS CO-KRISTALL MIT L-PYROGLUTAMINSAEURE, UND INSBESONDERE ALS ERTUGLIFLOZIN L-PYROGLUTAMINSAEURE; REGISTRATION NO/DATE: EU/1/18/1267 (MITTEILUNG) 20180323
2334687	2018C/027	Belgium		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
2334687	C20180023 00266	Estonia		PRODUCT NAME: ERTUGLIFLOSIIN;REG NO/DATE: EU/1/18/1267 23.03.2018

Market and Financial Analysis for Ertugliflozin (2023)

Last updated: February 16, 2026

Ertugliflozin, marketed under the brand name Steglatro by Pfizer, is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for type 2 diabetes management. Its market position hinges on competitive dynamics within the SGLT2 inhibitor space, patent expiration timelines, and evolving clinical guidelines.

Product Overview

• Approval Date: December 2017 by the FDA
• Indication: Improve glycemic control in adults with type 2 diabetes
• Mechanism: Blocks SGLT2 in kidneys to promote glucose excretion
• Formulation: Oral tablets (5 mg, 15 mg)

Market Landscape

• The SGLT2 inhibitor class includes drugs such as empagliflozin (Jardiance), canagliflozin (Invokana), and dapagliflozin (Farxiga).
• Ertugliflozin's sales peaked at ~$400 million in 2021.
• As of 2022, the drug ranks fourth among SGLT2 inhibitors in multiple markets, following Jardiance, Invokana, and Farxiga.
• The average wholesale price (AWP) in the U.S. ranges from $500 to $600 per month per patient.

Market Drivers

• Rising prevalence of type 2 diabetes — expected to reach 700 million globally by 2045 (IDF).
• Increasing adoption of SGLT2 inhibitors for heart failure and chronic kidney disease, expanding core indications.
• Guidelines from ADA (American Diabetes Association) endorse SGLT2 inhibitors for patients with cardiovascular or renal comorbidities.

Market Challenges

• Competition from entrenched brands (Jardiance, Farxiga) with broader indications.
• Patent exclusivity expiring in key markets:
  • U.S.: Patent protecting ertugliflozin expires in 2028
  • Europe: Patent clearance anticipated in 2029
• Generic entry expected post-expiry could reduce prices 50% or more, impacting revenue.

Financial Trajectory

• Pfizer’s revenue from Steglatro increased 15% year-over-year until 2021.
• Contribution to Pfizer's diabetes segment remains modest, representing approximately 4% of total revenue.
• Operating margins are expected to decline post-generic entry, with potential erosion of profits starting around 2028.

Forecast Scenarios

• Scenario A (Conservative): Patent expiration in 2028, generic competition reduces sales to 25% of peak levels by 2030.
• Scenario B (Aggressive): Accelerated uptake of combination therapies and expanded indications sustains sales through 2028, with a quick decline afterward.
• Scenario C (Strategic Diversification): Pfizer leverages formulation improvements and new indications, delaying generic impact.

Regulatory and Patent Strategies

• Pfizer has pursued patent extension tactics via method of use claims and formulation patents.
• Patent defenses extend exclusivity to 2028–2029.
• Ongoing litigation in some jurisdictions aims to prolong market protection.

Global Market Considerations

• U.S. accounts for roughly 60% of ertrugliflozin revenues.
• Emerging markets present growth opportunities but face pricing pressures and regulatory hurdles.
• Local reimbursement policies significantly influence revenue potential.

Investment Outlook

• Short-term: Steglatro maintains growth driven by diabetes management needs.
• Medium-term: Sales plateau as patent expiry nears.
• Long-term: Revenue decline expected post-2028, unless Pfizer introduces next-generation formulations or expands indications.

Key Takeaways

• Ertugliflozin holds a significant position within the SGLT2 class but faces imminent patent expiry and generic competition.
• Pfizer's continued profitability depends on successfully extending patent protections and expanding uses.
• Market growth driven by a global increase in diabetes prevalence may offset some revenue loss but unlikely to fully compensate for patent attrition.
• Strategic investments in formulation innovations and expansion into new indications could alter the forecast trajectory.

Frequently Asked Questions

1. When will generic ertugliflozin become available?
   Patent expiration in the U.S. is projected for 2028, with patent challenges and litigation possibly influencing the exact timeline.

2. What are the main competitors?
   Jardiance (empagliflozin), Invokana (canagliflozin), and Farxiga (dapagliflozin).

3. How does the patent strategy influence revenue?
   Patent protections delay generic entry, maintaining pricing power and revenue levels.

4. Could new indications extend its market viability?
   Yes, especially if label expansions include heart failure or chronic kidney disease for diverse patient groups.

5. What regulatory risks exist?
   Patent challenges, label restrictions, or withdrawal due to safety concerns could impact market access.

References

[1] IQVIA, "Pharmaceutical Market Data," 2022.
[2] FDA, "Ertugliflozin (Steglatro) Approval Letter," December 2017.
[3] International Diabetes Federation, "Diabetes Atlas," 2022.
[4] Pfizer Annual Reports 2021-2022.