Details for New Drug Application (NDA): 209805
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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: | ⤷ Sign Up | Patent Expiration: | May 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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