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Cipla
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Generated: August 18, 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 three 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 thirty 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:6
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 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:➤ Sign UpPatent 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:➤ Sign UpPatent 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:➤ Sign UpPatent 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 021995-003 Oct 16, 2006 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chubb
Cerilliant
Boehringer Ingelheim
Medtronic
Express Scripts
Baxter
UBS
Fuji

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