Details for New Drug Application (NDA): 209803
NDA 209803 describes STEGLATRO, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the STEGLATRO profile page.
The generic ingredient in STEGLATRO is ertugliflozin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ertugliflozin profile page.
The generic ingredient in STEGLATRO is ertugliflozin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ertugliflozin profile page.
Summary for 209803
| Tradename: | STEGLATRO |
| Applicant: | Msd Sub Merck |
| Ingredient: | ertugliflozin |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209803
Generic Entry Date for 209803*:
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.
Suppliers and Packaging for NDA: 209803
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STEGLATRO | ertugliflozin | TABLET;ORAL | 209803 | NDA | Merck Sharp & Dohme LLC | 0006-5363 | 0006-5363-03 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03) |
| STEGLATRO | ertugliflozin | TABLET;ORAL | 209803 | NDA | Merck Sharp & Dohme LLC | 0006-5363 | 0006-5363-06 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 19, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 19, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Dec 19, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 19, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES | ||||||||
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