Details for New Drug Application (NDA): 202343

NDA 202343 describes JUVISYNC, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent 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 forty drug master file entries for this compound. Additional details are available on the simvastatin; sitagliptin phosphate profile page.

Summary for 202343

Tradename:	JUVISYNC
Applicant:	Merck Sharp Dohme
Ingredient:	simvastatin; sitagliptin phosphate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202343

Constraining patent/regulatory exclusivity:

7,326,708*PED

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Oct 7, 2011	TE:		RLD:	Yes
Patent:	7,326,708*PED	Patent Expiration:	Oct 11, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Oct 7, 2011	TE:		RLD:	Yes
Patent:	7,326,708*PED	Patent Expiration:	Oct 11, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Oct 7, 2011	TE:		RLD:	Yes
Patent:	7,326,708*PED	Patent Expiration:	Oct 11, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202343

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	7,459,428
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011	8,168,637
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011	6,890,898
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	6,890,898
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	8,168,637
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012	7,459,428
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012	8,168,637

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