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INPEFA Drug Patent Profile

When do Inpefa patents expire, and when can generic versions of Inpefa launch?

Inpefa is a drug marketed by Lexicon Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has eighty patent family members in thirty-two countries.

The generic ingredient in INPEFA is sotagliflozin. One supplier is listed for this compound. Additional details are available on the sotagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Inpefa

Inpefa will be eligible for patent challenges on May 26, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 26, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INPEFA

International Patents:	80
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for INPEFA
What excipients (inactive ingredients) are in INPEFA?	INPEFA excipients list
DailyMed Link:	INPEFA at DailyMed

See drug prices for INPEFA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216203

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.

Pharmacology for INPEFA

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

Anatomical Therapeutic Chemical (ATC) Classes for INPEFA

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 INPEFA

INPEFA is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INPEFA

FDA Regulatory Exclusivity protecting INPEFA

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	216203-001	May 26, 2023		RX	Yes	No			Y	Y
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
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			Y	Y

EU/EMA Drug Approvals for INPEFA

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 INPEFA

When does loss-of-exclusivity occur for INPEFA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

China

Colombia

Denmark

Eurasian Patent Organization

European Patent Office

Germany

Hong Kong

Hungary

Israel

Japan

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INPEFA around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	98123	ІНГІБІТОРИ КОТРАНСПОРТЕРА НАТРІЙГЛЮКОЗИ 2 І ЇХ ЗАСТОСУВАННЯ[ИНГИБИТОРЫ КОТРАНСПОРТЕРА НАТРИЙГЛЮКОЗЫ 2 И ИХ ПРИМЕНЕНИЕ (INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2 AND METHODS OF THEIR USE)
Australia	2007304971	Phlorizin analogs as inhibitors of sodium glucose co-transporter 2
Canada	2730931	FORMES SOLIDES DE (2S,3R,4R,5S,6R)-2-(4-CHLORO-3-(4-ETHOXYBENZYL)PHENYL)-6-(METHYLTHIO)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL ET PROCEDES DE LEUR UTILISATION (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)
China	107629097	种化合物的固体形式及其使用方法 (Solid forms of compound and methods of their use)
Hong Kong	1183020	鈉-葡萄糖協同轉運蛋白 的抑制劑及其用法 (INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2 AND METHODS OF THEIR USE - 2)

Supplementary Protection Certificates for INPEFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2089361	122019000077	Germany		PRODUCT NAME: SOTAGLIFLOZIN, ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 20190426
2089361	2019/044	Ireland		PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1363 20190430
2089361	1990043-0	Sweden		PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. 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	132019000000113	Italy		PRODUCT NAME: SOTAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYNQUISTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1363, 20190430