Sotagliflozin - Generic Drug Details

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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

Generic Entry Date for sotagliflozin^: ⤷ Sign Up* 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
Juvenile Diabetes Research Foundation	Phase 4
Steno Diabetes Center Copenhagen	Phase 4
Glostrup University Hospital, Copenhagen	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

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Glossary

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

EU/EMA Drug Approvals for sotagliflozin

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for sotagliflozin

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Country	Patent Number	Title	Estimated Expiration
Argentina	072807	FORMAS SOLIDAS DEL COMPUESTOS (2R,3R,4R,5S,6R)-2-(4-CLORO-3-ETOXIBENCIL)FENIL)6-(METILTIO)TETAHIDRO-2H-PIRAN-3,4,5-TRIOL Y METODOS PARA SU USO COMO INHIBIDOR DEL COTRANSPORTADOR 2 DE SODIO-GLUCOSA (SGLT2)	⤷ Sign Up
Taiwan	I499414		⤷ Sign Up
Germany	602007012292		⤷ Sign Up
Colombia	6351797	FORMAS SOLIDAS DE (2S,3R,4R,5S,6R)-2-(4-CLORO-3-(4-ETOXIBENCIL) FENIL)-O-(METILTIO) TETRAHIDRO-2H-PIRAN- 3,4,5-TRIOL Y METODOS PARA SU USO	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010009197		⤷ Sign Up
South Korea	20170010069	고체 형태의 테트라히드로-2Ｈ-피란-3,4,5-트리올 및 그의 사용 방법 (23456-2-4--3-4--6--2--345- SOLID FORMS OF 2S3R4R5S6R-2-4-CHLORO-3-4-ETHOXYBENZYLPHENYL-6-METHYLTHIOTETRAHYDRO-2H-PYRAN-345-TRIOL AND METHODS OF THEIR USE)	⤷ Sign Up
Poland	2089361		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sotagliflozin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2089361	2019/044	Ireland	⤷ Sign Up	PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1363 20190430
2089361	19C1053	France	⤷ Sign Up	PRODUCT NAME: SOTAGLIFLOZINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/19/1363 20190430
2089361	301003	Netherlands	⤷ Sign Up	PRODUCT NAME: SOTAGLIFLOZIN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1363 20190430
2089361	C201930054	Spain	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/19/1363 20190430
2089361	122019000077	Germany	⤷ Sign Up	PRODUCT NAME: SOTAGLIFLOZIN, ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 20190426
2089361	42/2019	Austria	⤷ Sign Up	PRODUCT NAME: SOTAGLIFLOZIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 (MITTEILUNG) 20190430
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.