Sotagliflozin - Generic Drug Details
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What are the generic drug sources for sotagliflozin and what is the scope of patent protection?
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 |
---|---|
Juvenile Diabetes Research Foundation | Phase 1/Phase 2 |
University of California, San Diego | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for sotagliflozin
US Patents and Regulatory Information for sotagliflozin
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 |
---|---|---|---|
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) | ⤷ Try a Trial |
Australia | 2007304971 | Phlorizin analogs as inhibitors of sodium glucose co-transporter 2 | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
Japan | 2011528366 | ⤷ 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 | 122019000077 | Germany | ⤷ Try a Trial | PRODUCT NAME: SOTAGLIFLOZIN, ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 20190426 |
2089361 | 2019/044 | Ireland | ⤷ Try a Trial | PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1363 20190430 |
2089361 | 1990043-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/19/1363 20190430 |
2089361 | 301003 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SOTAGLIFLOZIN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1363 20190430 |
2089361 | 132019000000113 | Italy | ⤷ Try a Trial | PRODUCT NAME: SOTAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYNQUISTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1363, 20190430 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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