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Last Updated: September 26, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202270


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NDA 202270 describes JANUMET XR, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the JANUMET XR profile page.

The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.
Summary for 202270
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 202270
Generic Entry Date for 202270*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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: 202270
Suppliers and Packaging for NDA: 202270
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270 NDA Merck Sharp & Dohme Corp. 0006-0078 0006-0078-28 2 BOTTLE in 1 CARTON (0006-0078-28) > 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14)
JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270 NDA Merck Sharp & Dohme Corp. 0006-0078 0006-0078-61 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61)
Paragraph IV (Patent) Challenges for 202270
Tradename Dosage Ingredient NDA Submissiondate
JANUMET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; sitagliptin phosphate 202270 2012-10-22
JANUMET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; sitagliptin phosphate 202270 2012-03-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG;EQ 50MG BASE
Approval Date:Feb 2, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 4, 2023
Regulatory Exclusivity Use:ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Regulatory Exclusivity Expiration:Aug 12, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Regulatory Exclusivity Expiration:Feb 12, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 202270

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Express Scripts
McKinsey
Baxter
Merck

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