Details for New Drug Application (NDA): 209806
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NDA 209806 describes SEGLUROMET, which is a drug marketed by Msd Sub Merck 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 SEGLUROMET profile page.
The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. One supplier is listed for this compound. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.
The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. One supplier is listed for this compound. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.
Summary for 209806
| Tradename: | SEGLUROMET |
| Applicant: | Msd Sub Merck |
| Ingredient: | ertugliflozin; metformin hydrochloride |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209806
Generic Entry Date for 209806*:
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: 209806
Suppliers and Packaging for NDA: 209806
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806 | NDA | Merck Sharp & Dohme LLC | 0006-5369 | 0006-5369-03 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-5369-03) |
| SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806 | NDA | Merck Sharp & Dohme LLC | 0006-5369 | 0006-5369-06 | 180 TABLET, FILM COATED in 1 BOTTLE (0006-5369-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
| Approval Date: | Dec 19, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 17, 2024 | ||||||||
| Regulatory Exclusivity Use: | REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 13, 2030 | 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 | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 21, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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