INPEFA Drug Patent Profile
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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-one patent family members in thirty-three 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
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Summary for INPEFA
| International Patents: | 81 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INPEFA
*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 |
US Patents and Regulatory Information for INPEFA
INPEFA is protected by three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of INPEFA is ⤷ Sign Up.
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF RISK OF CARDIOVASCULAR DEATH, HOSPITALIZATION FOR HEART FAILURE, AND URGENT HEART FAILURE IN ADULTS WITH HEART FAILURE OR TYPE 2 DIABETES MELLITUS, CHRONIC KIDNEY DISEASE, AND OTHER CARDIOVASCULAR RISK FACTORS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF RISK OF CARDIOVASCULAR DEATH, HOSPITALIZATION FOR HEART FAILURE, AND URGENT HEART FAILURE IN ADULTS WITH HEART FAILURE OR TYPE 2 DIABETES MELLITUS, CHRONIC KIDNEY DISEASE, AND OTHER CARDIOVASCULAR RISK FACTORS
FDA Regulatory Exclusivity protecting INPEFA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ 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 | ⤷ 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 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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
Patent: 3047
Patent: PIPERIDINAS Y TETRAHIDROPIRANOS SUSTITUIDOS COMO INHIBIDORES DE LA ACTIVIDAD DE SGLT2, UNA FORMULACION FARMACEUTICA QUE LOS COMPRENDE, UNA UNIDAD DE DOSIFICACION QUE LOS EMPLEA Y SU UTILIZACION EN LA DISMINUCION DE LA GLUCEMIA Y EN EL TRATAMIENTO DE ENFERMEDADES RELACIONADAS.
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07304971
Patent: Phlorizin analogs as inhibitors of sodium glucose co-transporter 2
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 96888
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0717156
Patent: INIBIDORES DO CO-TRANSPORTADOR 2 DA GLICOSE DE SÓDIO E MÉTODOS PARA O SEU USO
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 64688
Patent: INHIBITEURS DE CO-TRANSPORTEUR 2 DE SODIUM GLUCOSE ET PROCEDES D'UTILISATION DE CEUX-CI (INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2 AND METHODS OFTHEIR USE)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1343296
Patent: Inhibitors of sodium glucose co-transporter 2 and methods of their use
Estimated Expiration: ⤷ Sign Up
Patent: 3254119
Patent: Inhibitors of sodium glucose co-transporter 2 and methods of their use
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 60293
Patent: INHIBIDORES DEL COTRANSPORTADOR 2 DE SODIO Y GLUCOSA Y METODOS PARA SU USO
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 89361
Estimated Expiration: ⤷ Sign Up
Patent: 08841
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 6511
Patent: ИНГИБИТОРЫ КОТРАНСПОРТЕРА НАТРИЙ-ГЛЮКОЗЫ 2 И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2 AND METHODS OF THEIR USE)
Estimated Expiration: ⤷ Sign Up
Patent: 0970337
Patent: ИНГИБИТОРЫ КОТРАНСПОРТЕРА НАТРИЙ-ГЛЮКОЗЫ 2 И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 89361
Patent: INHIBITEURS DE CO-TRANSPORTEUR 2 DE SODIUM GLUCOSE ET PROCÉDÉS D'UTILISATION DE CEUX-CI (INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2 AND METHODS OF THEIR USE)
Estimated Expiration: ⤷ Sign Up
Patent: 08841
Patent: Analogues de phlorizine comme inhibiteurs de SGLT2 (Phlorizin analogs as SGLT2 inhibitors)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1053
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2007012292
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 24863
Patent: INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2 AND METHODS OF THEIR USE
Estimated Expiration: ⤷ Sign Up
Patent: 83020
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 900038
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7836
Patent: אנלוגים של פלוריזין ותכשירים רוקחיים המכילים אותם (Phlorizin analogs and pharmaceutical compositions comprising them)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 83625
Estimated Expiration: ⤷ Sign Up
Patent: 01845
Estimated Expiration: ⤷ Sign Up
Patent: 89453
Estimated Expiration: ⤷ Sign Up
Patent: 10504998
Estimated Expiration: ⤷ Sign Up
Patent: 13079243
Patent: PHLORIZIN ANALOG AS INHIBITOR OF SODIUM GLUCOSE CO-TRANSPORTER 2
Estimated Expiration: ⤷ Sign Up
Patent: 15120736
Patent: ナトリウム／グルコース共輸送体２の阻害剤としてのフロリジンアナログ (PHLORIZIN ANALOGS AS INHIBITORS OF SODIUM-GLUCOSE CO-TRANSPORTER 2)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09003305
Patent: INHIBIDORES DE CO-TRANSPORTADOR DE GLUCOSA DE SODIO 2 Y METODO PARA SU USO. (PHLORIZIN ANALOGS AS INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2.)
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1003
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5811
Patent: INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2 AND METHODS OF THEIR USE
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 5139
Estimated Expiration: ⤷ Sign Up
Patent: 091700
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 89361
Estimated Expiration: ⤷ Sign Up
Patent: 08841
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 89361
Estimated Expiration: ⤷ Sign Up
Patent: 08841
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0902231
Patent: Phlorizin analogs as inhibitors of sodium glucose cotransporter 2
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1492277
Estimated Expiration: ⤷ Sign Up
Patent: 090061072
Patent: PHLORIZIN ANALOGS AS INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2
Estimated Expiration: ⤷ Sign Up
Patent: 150002889
Patent: PHLORIZIN ANALOGS AS INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 62684
Estimated Expiration: ⤷ Sign Up
Patent: 77216
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 99414
Estimated Expiration: ⤷ Sign Up
Patent: 0826929
Patent: Inhibitors of sodium glucose co-transporter 2 and methods of their use
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 123
Patent: 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)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Taiwan | 200826929 | Inhibitors of sodium glucose co-transporter 2 and methods of their use | ⤷ Sign Up |
| 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 | ⤷ Sign Up |
| Taiwan | I499414 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INPEFA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2089361 | 132019000000113 | Italy | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: SOTAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; 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 |
| >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.
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