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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 022044


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NDA 022044 describes JANUMET, which is a drug marketed by Msd Sub Merck and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the JANUMET profile page.

The generic ingredient in JANUMET 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 022044
Tradename:JANUMET
Applicant:Msd Sub Merck
Ingredient:metformin hydrochloride; sitagliptin phosphate
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022044
Generic Entry Date for 022044*:
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: 022044
Suppliers and Packaging for NDA: 022044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044 NDA Merck Sharp & Dohme LLC 0006-0575 0006-0575-03 2 BOTTLE in 1 CARTON (0006-0575-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0575-02)
JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044 NDA Merck Sharp & Dohme LLC 0006-0575 0006-0575-56 4 POUCH in 1 CARTON (0006-0575-56) / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 50MG BASE
Approval Date:Mar 30, 2007TE: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:Jun 4, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Sign UpPatent Expiration:May 24, 2027Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022044

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 ⤷  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.