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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Queensland Health
AstraZeneca
Argus Health
Deloitte
Boehringer Ingelheim
Colorcon
Farmers Insurance
Cerilliant
UBS
Citi

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202343

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NDA 202343 describes JUVISYNC, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the JUVISYNC profile page.

The generic ingredient in JUVISYNC is simvastatin; sitagliptin phosphate. There are thirty-nine drug master file entries for this compound. Additional details are available on the simvastatin; sitagliptin phosphate profile page.

Summary for 202343

Tradename:1
Applicant:1
Ingredient:1
Patents:8
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 7, 2011TE:RLD:Yes
Patent:► SubscribePatent Expiration:Apr 24, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
Patent:► SubscribePatent 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 SIMVASTATIN IS APPROPRIATE
Patent:► SubscribePatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN

Expired Orange Book Patents for NDA: 202343

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-004Sep 18, 2012► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-003Oct 7, 2011► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-005Sep 18, 2012► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-002Oct 7, 2011► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-001Oct 7, 2011► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-006Sep 18, 2012► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Julphar
McKinsey
Argus Health
Deloitte
Moodys
US Department of Justice
Citi
Chubb
US Army

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