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Deloitte
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Federal Trade Commission
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Generated: April 25, 2018

DrugPatentWatch Database Preview

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 four suppliers. There are six 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 twenty-eight drug master file entries for this compound. Four 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:6
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
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 N 0006-0112-28
JANUVIA sitagliptin phosphate TABLET;ORAL 021995 NDA Merck Sharp & Dohme Corp. 0006-0112 N 0006-0112-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Oct 16, 2006TE:RLD:Yes
Patent:➤ Try a Free 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:➤ Try a Free TrialPatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR A PPAR-GAMMA AGONIST AND/OR SULFONYLUREA AND/OR INSULIN
Patent:➤ Try a Free TrialPatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR A PPAR-GAMMA AGONIST AND/OR SULFONYLUREA AND/OR 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 021995-001 Oct 16, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Merck
Queensland Health
Julphar
McKesson
UBS
McKinsey
Farmers Insurance
US Army

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