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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 021995


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NDA 021995 describes JANUVIA, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JANUVIA profile page.

The generic ingredient in JANUVIA is sitagliptin phosphate. There are thirty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
Summary for 021995
Tradename:JANUVIA
Applicant:Merck Sharp Dohme
Ingredient:sitagliptin phosphate
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021995
Generic Entry Date for 021995*:
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: 021995
Medical Subject Heading (MeSH) Categories for 021995
Suppliers and Packaging for NDA: 021995
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JANUVIA sitagliptin phosphate TABLET;ORAL 021995 NDA Merck Sharp & Dohme Corp. 0006-0112 0006-0112-28 100 BLISTER PACK in 1 CARTON (0006-0112-28) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0112-01)
JANUVIA sitagliptin phosphate TABLET;ORAL 021995 NDA Merck Sharp & Dohme Corp. 0006-0112 0006-0112-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-0112-31)
Paragraph IV (Patent) Challenges for 021995
Tradename Dosage Ingredient NDA Submissiondate
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-11-06
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-06-25
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-06-19
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2010-10-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Oct 16, 2006TE:RLD:Yes
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
Patent:  Start TrialPatent Expiration:Jul 26, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
Patent:  Start TrialPatent Expiration:Jul 26, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN

Expired US Patents for NDA 021995

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006   Start Trial   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006   Start Trial   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006   Start Trial   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006   Start Trial   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006   Start Trial   Start Trial
>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.