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Last Updated: April 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209805


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NDA 209805 describes STEGLUJAN, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are eight 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.
Summary for 209805
Tradename:STEGLUJAN
Applicant:Merck Sharp Dohme
Ingredient:ertugliflozin; sitagliptin phosphate
Patents:8
Generic Entry Opportunity 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
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 Corp. 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 Corp. 0006-5367 0006-5367-06 90 TABLET, FILM COATED in 1 BOTTLE (0006-5367-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;EQ 100MG BASE
Approval Date:Dec 19, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jul 26, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
Patent:  Start TrialPatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:ERTUGLIFLOZIN IN COMBINATION WITH SITAGLIPTIN AND IN FURTHER COMBINATION WITH METFORMIN AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS

Expired US Patents for NDA 209805

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Serving leading biopharmaceutical companies globally:

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