Details for New Drug Application (NDA): 209805
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NDA 209805 describes STEGLUJAN, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the STEGLUJAN profile page.
The generic ingredient in STEGLUJAN is ertugliflozin; sitagliptin phosphate. One supplier is listed for this compound. Additional details are available on the ertugliflozin; sitagliptin phosphate profile page.
The generic ingredient in STEGLUJAN is ertugliflozin; sitagliptin phosphate. One supplier is listed for this compound. Additional details are available on the ertugliflozin; sitagliptin phosphate profile page.
Summary for 209805
| Tradename: | STEGLUJAN |
| Applicant: | Msd Sub Merck |
| Ingredient: | ertugliflozin; sitagliptin phosphate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209805
Generic Entry Date for 209805*:
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: 209805
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 209805
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805 | NDA | Merck Sharp & Dohme LLC | 0006-5367 | 0006-5367-03 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5367-03) |
| STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805 | NDA | Merck Sharp & Dohme LLC | 0006-5367 | 0006-5367-06 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-5367-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;EQ 100MG BASE | ||||
| 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: | ⤷ Subscribe | Patent Expiration: | May 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Subscribe | 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 | ||||||||
Expired US Patents for NDA 209805
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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