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 patent family members in thirty-two countries.
One supplier is listed for this compound.
Summary for SOTAGLIFLOZIN
International Patents: | 80 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 72 |
Clinical Trials: | 39 |
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*:
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 |
---|---|
University of California, San Diego | Phase 1/Phase 2 |
Juvenile Diabetes Research Foundation | Phase 1/Phase 2 |
Juan Badimon | Phase 4 |
Pharmacology for SOTAGLIFLOZIN
Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Lexicon Pharms Inc | INPEFA | sotagliflozin | TABLET;ORAL | 216203-002 | May 26, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lexicon Pharms Inc | INPEFA | sotagliflozin | TABLET;ORAL | 216203-001 | May 26, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Lexicon Pharms Inc | INPEFA | sotagliflozin | TABLET;ORAL | 216203-001 | May 26, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 201006808 | 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 | ⤷ Try a Trial |
China | 103254119 | Inhibitors of sodium glucose co-transporter 2 and methods of their use | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
Brazil | PI0717156 | INIBIDORES DO CO-TRANSPORTADOR 2 DA GLICOSE DE SÓDIO E MÉTODOS PARA O SEU USO | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SOTAGLIFLOZIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2089361 | SPC/GB19/054 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/19/1363 (NI) 20190430; UK PLGB 53567/0001 20190430 |
2089361 | CR 2019 00042 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SOTAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1363 20190430 |
2089361 | 42/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: SOTAGLIFLOZIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 (MITTEILUNG) 20190430 |
2089361 | C201930054 | Spain | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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