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:	43
Patent Applications:	396
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
Glostrup University Hospital, Copenhagen	Phase 4
King's College London	Phase 4
Juvenile Diabetes Research Foundation	Phase 4

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	216203-001	May 26, 2023		RX	Yes	No			Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No			Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes

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/004889 Zynquista 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
Taiwan	200826929	Inhibitors of sodium glucose co-transporter 2 and methods of their use
South Korea	20110031196	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 METHODS OF THEIR USE
Taiwan	I499414
Russian Federation	2505543	ТВЕРДЫЕ ФОРМЫ (2S,3R,4R,5S,6R)-2-(4-ХЛОР-3-(4-ЭТОКСИБЕНЗИЛ)ФЕНИЛ)-6-(МЕТИЛТИО)ТЕТРАГИДРО-2Н-ПИРАН-3,4,5-ТРИОЛА И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (SOLID FORMS (2S,3R,4R,5S,6R)-2-(4-CHLORO-3-(4-ETHOXYBENZIL)PHENYL)-6-(METHYLTHIO)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL AND METHODS FOR THEIR OBTAINING)

Supplementary Protection Certificates for SOTAGLIFLOZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 2019 00042	Denmark		PRODUCT NAME: SOTAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1363 20190430
2089361	122019000077	Germany		PRODUCT NAME: SOTAGLIFLOZIN, ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 20190426
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