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Last Updated: February 18, 2020

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 one supplier. There are six 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. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.
Summary for 202270
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
Patent:  Start TrialPatent Expiration:Jul 26, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
Patent:  Start TrialPatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
Patent:  Start TrialPatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS

Expired US Patents for NDA 202270

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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