Details for New Drug Application (NDA): 216203
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NDA 216203 describes INPEFA, which is a drug marketed by Lexicon Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the INPEFA profile page.
The generic ingredient in INPEFA is sotagliflozin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sotagliflozin profile page.
The generic ingredient in INPEFA is sotagliflozin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sotagliflozin profile page.
Summary for 216203
| Tradename: | INPEFA |
| Applicant: | Lexicon Pharms Inc |
| Ingredient: | sotagliflozin |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216203
Generic Entry Date for 216203*:
Constraining patent/regulatory exclusivity:
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 NDA: 216203
| Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 216203
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INPEFA | sotagliflozin | TABLET;ORAL | 216203 | NDA | Lexicon Pharmaceuticals, Inc. | 70183-221 | 70183-221-07 | 1 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACK |
| INPEFA | sotagliflozin | TABLET;ORAL | 216203 | NDA | Lexicon Pharmaceuticals, Inc. | 70183-221 | 70183-221-30 | 30 TABLET in 1 BOTTLE (70183-221-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 26, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 26, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 7,781,577 | Patent Expiration: | May 4, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| 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: | 8,217,156 | Patent Expiration: | Oct 7, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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