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Last Updated: November 7, 2024

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.
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
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:RXDosage:TABLET;ORALStrength5MG;EQ 100MG BASE
Approval Date:Dec 19, 2017TE: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 UpPatent Expiration:May 24, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Jul 13, 2030Product Flag?YSubstance Flag?YDelist 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.