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:	52
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
Abbott	PHASE3
National Institutes of Health (NIH)	PHASE3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	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			Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes			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
Ukraine	106048	ТВЕРДЫЕ ФОРМЫ (2S,3R,4R,5S,6R)-2-( 4-ХЛОР-3(4-ЭТОКСИБЕНЗИЛ)ФЕНИЛ)-6-(МЕТИЛТИО)ТЕТРАГИДРО-2H-ПИРАН-3,4,5-ТРИОЛА И ИХ ПРИМЕНЕНИЕ;ТВЕРДІ ФОРМИ (2S,3R,4R,5S,6R)-2-(4-ХЛОР-3(4-ЕТОКСИБЕНЗИЛ)ФЕНІЛ)-6-(МЕТИЛТІО)ТЕТРАГІДРО-2H-ПІРАН-3,4,5-ТРІОЛУ І ЇХ ЗАСТОСУВАННЯ (SOLID FORMS OF (2S, 3R, 4R, 5S, 6R)-2-(4-CHLORO-3-(4-ETHOXYBENZYL)PHENYL)-6-(METHYLTHIO)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL AND USE THEREOF)
South Korea	101492277
Taiwan	200826929	Inhibitors of sodium glucose co-transporter 2 and methods of their use

Supplementary Protection Certificates for sotagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2089361	CR 2019 00042	Denmark		PRODUCT NAME: SOTAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1363 20190430
2089361	132019000000113	Italy		PRODUCT NAME: SOTAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYNQUISTA); AUTHORISATION NUMBER(S) AND DATE(S): 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

Market Dynamics and Financial Trajectory for SOTAGLIFLOZIN

Last updated: March 5, 2026

What is SOTAGLIFLOZIN?

Sotagliflozin is an investigational dual SGLT1 and SGLT2 inhibitor developed by Lexicon Pharmaceuticals, targeting type 1 and type 2 diabetes. It combines inhibition of renal glucose reabsorption (via SGLT2) and intestinal glucose absorption (via SGLT1). With potential applications across multiple diabetes subtypes, its market positioning centers on improving glycemic control with lower hypoglycemia risk.

Regulatory Status and Development Timeline

• Initial Submission: Regulatory submissions in the US and EU began in 2021, based on phase 3 trial data.
• FDA Decision: As of 2023, the FDA has not approved SOTAGLIFLOZIN, citing safety concerns, primarily diabetic ketoacidosis.
• European Review: The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion in 2022. Approval remains pending potential further data.

Market Size and Growth Drivers

Global Diabetes Medication Market

• Market Value (2022): Approximately USD 70 billion.
• Expected CAGR (2022-2028): 6.8%, reaching USD 115 billion by 2028 (source: Grand View Research).
• Key Players: Novo Nordisk, Eli Lilly, AstraZeneca, Boehringer Ingelheim.

Target Market for SOTAGLIFLOZIN

• Type 2 Diabetes Patients: Estimated at 536 million globally (IDF, 2021).
• Type 1 Diabetes Patients: Around 10 million worldwide.
• Unmet Needs: Patients inadequately controlled with current therapies, with a focus on reducing hypoglycemia and weight gain.

Competitive Landscape

Drug	Class	Market Approval	Major Advantages	Limitations
Canagliflozin (Invokana)	SGLT2 inhibitor	2013	Proven cardiovascular benefits	Risk of ketoacidosis, genital infections
Dapagliflozin (Farxiga)	SGLT2 inhibitor	2014	Extensive safety profile	Limited efficacy in type 1 diabetes
Empagliflozin (Jardiance)	SGLT2 inhibitor	2014	Cardiovascular reduction	Expensive, risk of dehydration
SOTAGLIFLOZIN (candidate)	SGLT1/2 inhibitor	Pending approval	Dual mechanism, potential for better control	Safety concerns, regulatory delays

Financial Trajectory and Commercial Outlook

Potential Revenue

• Forecast (2023-2028): USD 1-2 billion globally if approved and marketed.
• Pricing Models: Similar to SGLT2 inhibitors, with annual costs around USD 3,000–5,000 per patient.

Barriers to Commercialization

• Regulatory Hurdles: Pending safety profile, especially regarding DKA risks.
• Market Penetration Challenges: Competition from established SGLT2 inhibitors and GLP-1 receptor agonists.
• Clinical Differentiation: Need for clear evidence of superior efficacy or safety to justify premium pricing.

Investment and Industry Impact

• Investment Trends: Lexicon Pharmaceuticals’ stock performance correlates with interim trial results; negative safety signals in 2022 impacted valuation.
• Partnering Opportunities: Potential for licensing or partnership with larger pharma for late-stage development.

Strategic Considerations

• Safety Profile: Establishing safety in larger trials remains critical. Cardiovascular outcome data will influence approval and reimbursement.
• Market Entry Timing: Approval delays could erode first-mover advantage, emphasizing the importance of rapid regulatory resolution.
• Differentiation Strategy: Focus on unique benefits like dual mechanism and reduced side-effect profile.

Conclusion

Sotagliflozin’s market potential hinges on overcoming regulatory safety concerns. If approved, it could carve a niche in diabetes management, especially among patients with inadequate control on existing therapies. Its initial financial trajectory appears limited by regulatory approvals and competitive pressures. Long-term success will depend on validated safety and efficacy data demonstrating clear advantages over current treatment options.

Key Takeaways

• SOTAGLIFLOZIN is an unapproved dual SGLT1/2 inhibitor with potential for wide application in diabetes.
• Regulatory reviews are ongoing, with safety concerns impacting approval prospects.
• The global diabetes drug market exceeds USD 70 billion, with CAGR of nearly 7%, offering substantial revenue potential if approved.
• Competition includes well-established SGLT2 inhibitors, challenging SOTAGLIFLOZIN’s market entry.
• Financial success depends on safety validation, timely approval, and differentiation through clinical benefits.

FAQs

1. What are the main safety concerns with SOTAGLIFLOZIN?
The primary concern is diabetic ketoacidosis (DKA), similar to issues seen with other SGLT inhibitors. Safety signals from trials have delayed regulatory review.

2. How does SOTAGLIFLOZIN differ from other SGLT2 inhibitors?
It inhibits both SGLT1 in the intestine and SGLT2 in the kidneys, potentially reducing postprandial glucose more effectively and lowering hypoglycemia risk.

3. When is market approval expected for SOTAGLIFLOZIN?
Pending regulatory review, approval could occur in late 2023 or 2024 if safety concerns are addressed satisfactorily.

4. What is the potential global market for SOTAGLIFLOZIN?
If approved, the drug could generate USD 1-2 billion annually, depending on market penetration and pricing.

5. Which companies are most affected by the development of SOTAGLIFLOZIN?
Established SGLT2 inhibitor makers like Novo Nordisk and Eli Lilly could face increased competition if SOTAGLIFLOZIN gains approval and demonstrates clinical advantages.

---

References

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th edition.
[2] Grand View Research. (2022). Diabetes Drugs Market Size, Share & Trends Analysis.
[3] EMA. (2022). Committee for Medicinal Products for Human Use (CHMP) review on SOTAGLIFLOZIN.
[4] Lexicon Pharmaceuticals. (2023). SOTAGLIFLOZIN Development Update.