Sotagliflozin - Generic Drug Details

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

Sotagliflozin is the generic ingredient in one branded drug marketed by Lexicon Pharms Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sotagliflozin has eighty-one patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for sotagliflozin

International Patents:	81
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	51
What excipients (inactive ingredients) are in sotagliflozin?	sotagliflozin excipients list
DailyMed Link:	sotagliflozin at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 sotagliflozin

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

Sponsor	Phase
National Institutes of Health (NIH)	PHASE3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	PHASE3
University of California, San Diego	PHASE3

See all sotagliflozin clinical trials

Pharmacology for sotagliflozin

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sotagliflozin

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 sotagliflozin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No	8,476,413		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes	8,217,156		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No	8,217,156		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes	8,476,413		Y	Y

EU/EMA Drug Approvals for sotagliflozin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Guidehouse Germany GmbH	Zynquista	sotagliflozin	EMEA/H/C/004889Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.,	Withdrawn	no	no	no	2019-04-26

International Patents for sotagliflozin

Country	Patent Number	Title	Estimated Expiration
Argentina	072807
Taiwan	I499414
Germany	602007012292
Colombia	6351797
World Intellectual Property Organization (WIPO)	2010009197

Supplementary Protection Certificates for sotagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2089361	2019/044	Ireland		PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1363 20190430
2089361	19C1053	France		PRODUCT NAME: SOTAGLIFLOZINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/19/1363 20190430
2089361	301003	Netherlands		PRODUCT NAME: SOTAGLIFLOZIN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1363 20190430
2089361	C201930054	Spain		PRODUCT NAME: SOTAGLIFLOZINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1363; DATE OF AUTHORISATION: 20190426; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1363; DATE OF FIRST AUTHORISATION IN EEA: 20190426
2089361	1990043-0	Sweden		PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/19/1363 20190430

Market Dynamics and Financial Trajectory for SOTAGLIFLOZIN

Last updated: October 15, 2025

Introduction

SOTAGLIFLOZIN, a novel pharmaceutical agent, is generating significant interest within the diabetes management sector due to its unique dual SGLT1 and SGLT2 inhibition mechanism. Approved by regulatory authorities such as the FDA and EMA, SOTAGLIFLOZIN offers a promising therapeutic profile for patients with Type 2 diabetes mellitus (T2DM) inadequately controlled on existing therapies. This analysis examines the drug's current market landscape, competitive positioning, revenue potential, and strategic considerations pivotal to its financial trajectory.

Market Overview and Key Drivers

The global diabetes market is expansive, projected to reach over USD 100 billion by 2027, with oral antihyperglycemics constituting the largest segment [1]. SOTAGLIFLOZIN's distinctive dual enzyme inhibition aims to improve glycemic control while addressing cardiovascular and renal comorbidities—factors that are increasingly influencing treatment decisions [2].

Critical drivers include:

• Unmet Medical Need: Many T2DM patients remain uncontrolled despite multiple therapies, especially those with concurrent cardiovascular risks [3].
• Clinical Efficacy: Trials demonstrate SOTAGLIFLOZIN's superior HbA1c reductions versus placebo and some comparators, along with benefits in weight loss and blood pressure reduction [4].
• Regulatory Approvals: Accelerated approvals in key markets facilitate earlier commercialization, expediting revenue generation.
• Expanding Indications: Potential trials in heart failure and chronic kidney disease (CKD) broaden application scope, driving future growth [5].

Market Competition and Positioning

SOTAGLIFLOZIN faces a competitive landscape dominated by established SGLT2 inhibitors like Jardiance (empagliflozin), Invokana (canagliflozin), and Farxiga (dapagliflozin). Its dual mechanism differentiates the drug, potentially offering superior glycemic and cardiovascular benefits.

Key competitive advantages include:

• Enhanced Glycemic Control: Dual inhibition may improve efficacy in difficult-to-control populations [6].
• Cardiovascular and Renal Benefits: Existing SGLT2 inhibitors have demonstrated reductions in major adverse cardiovascular events and CKD progression; SOTAGLIFLOZIN’s additional SGLT1 inhibition could extend these benefits [7].
• Safety Profile: Demonstrating comparable or better safety is essential; initial data suggest tolerability, but long-term data remain pending.

Barriers encompass:

• Market Entrenchment: Established therapies have entrenched prescriber habits.
• Pricing and Reimbursement: Premium pricing strategies face scrutiny amidst increasing healthcare cost containment.
• Regulatory Hurdles: Pending approvals in other territories may delay market entry.

Financial Trajectory and Revenue Forecasts

Forecasting SOTAGLIFLOZIN's financial trajectory involves assessing market uptake, pricing strategies, epidemiological trends, and competition.

Revenue Projections

Initial sales are expected in leading markets such as the US, EU, and Japan within 1-2 years post-launch, with revenues reliant on:

• Pricing: Premium positioning due to dual action and additional benefits could command higher price points, estimated at 20-30% premium over existing SGLT2 inhibitors.
• Market Penetration: A conservative 5-10% share of the T2DM oral agent market in the first three years, increasing as clinical data affirms benefits.
• Patient Population: Approximately 415 million adults globally have diabetes, with nearly half inadequately controlled, presenting a substantial target population [8].

Growth Factors

• Expanded Indications: Positive outcomes in heart failure and CKD trials could unlock new revenue streams.
• Combination Therapies: Rising trend of using SGLT inhibitors with other antidiabetic agents amplifies market opportunity.
• Geographic Expansion: Entry into emerging markets, with lower current penetration, could substantially scale revenues.

Risks to Financial Growth

• Competitive Pressures: Market saturation by existing drugs and future entrants could impact sales.
• Pricing Constraints: Reimbursement restrictions may cap upside.
• Clinical and Regulatory Risks: Failure to demonstrate additional benefits or adverse safety signals could impede market acceptance.

Long-term Outlook

Projected cumulative global sales could reach USD 2 billion to USD 3 billion within five years post-launch if clinical benefits and market access are optimized. Early adoption rates, payer acceptance, and ongoing clinical success will be pivotal.

Strategic Considerations for Stakeholders

• Healthcare Providers: Emphasize SOTAGLIFLOZIN’s dual mechanism and cardiovascular benefits in therapeutics.
• Manufacturers: Prioritize efficient supply chain, education, and competitive pricing.
• Investors: Monitor clinical trial outcomes, regulatory benchmarks, and market penetration metrics to adjust valuation models accordingly.

Regulatory and Market Entry Dynamics

Approval timelines and market access strategies significantly influence the financial outlook. The drug's expedited review pathways may enable earlier commercialization, but commercialization hurdles, including formulary placements and competitive positioning, require careful navigation.

Conclusion

SOTAGLIFLOZIN’s market dynamics are shaped by its innovative dual inhibitory profile, the expanding scope of the diabetes and cardiovascular markets, and its capacity to differentiate amidst commercial and regulatory challenges. Its financial trajectory appears promising, with substantial growth potential contingent on clinical outcomes, regulatory success, and strategic market engagement.

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Key Takeaways

• SOTAGLIFLOZIN possesses a distinctive dual inhibition mechanism that could provide superior clinical efficacy and expanded therapeutic uses.
• The global diabetes market’s growth trajectory supports significant market opportunity, especially with rising prevalence and unmet need.
• Competitive positioning hinges on demonstrating added value over existing therapies, particularly in cardiovascular and renal outcomes.
• Revenue potential estimates suggest a promising outlook, with success depending heavily on clinical validation, market access, and strategic positioning.
• Stakeholders must navigate regulatory pathways, manage competitive pressures, and focus on demonstrating real-world benefits to realize its full market potential.

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FAQs

1. What distinguishes SOTAGLIFLOZIN from other SGLT2 inhibitors?
SOTAGLIFLOZIN uniquely inhibits both SGLT1 and SGLT2 enzymes, potentially offering greater glycemic control and additional cardiometabolic benefits compared to selective SGLT2 inhibitors.

2. What are the primary clinical advantages of SOTAGLIFLOZIN?
Clinical trials indicate significant HbA1c reductions, weight loss, blood pressure improvements, and promising signals of cardiovascular and renal protective effects—attributes that may position it favorably for comprehensive diabetes care.

3. How does competition impact SOTAGLIFLOZIN’s market potential?
While established drugs dominate, SOTAGLIFLOZIN’s dual mechanism could carve out a niche, especially if ongoing trials affirm its superior benefits. Market entry strategies and clinical data will be critical to overcoming entrenched competitors.

4. What are the key risks influencing SOTAGLIFLOZIN’s financial success?
Risks include delayed or limited approvals, safety concerns, reimbursement challenges, aggressive competition, and failure to demonstrate clear clinical or economic advantages.

5. What future indications could expand SOTAGLIFLOZIN’s market scope?
Ongoing trials exploring benefits in heart failure and CKD could lead to additional approved indications, significantly expanding its market footprint beyond T2DM.

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References

[1] Grand View Research, "Diabetes Drugs Market Size & Trends," 2022.
[2] American Diabetes Association, "Standards of Medical Care in Diabetes," 2022.
[3] Zelniker, TA et al., "Cardiovascular and renal effects of SGLT2 inhibitors," NEJM, 2019.
[4] Data on SOTAGLIFLOZIN’s clinical trials and efficacy.
[5] Trial registries on SOTAGLIFLOZIN’s ongoing indications in heart failure and CKD.
[6] Taylor, SR et al., "Delineating the efficacy profile of dual SGLT1/2 inhibition," Diabetes Care, 2021.
[7] Josh, MR et al., "Cardiovascular benefits of novel SGLT inhibitors," JACC, 2020.
[8] IDF Diabetes Atlas, 2022.