Details for New Drug Application (NDA): 205786

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NDA 205786 describes ISENTRESS, which is a drug marketed by Msd Sub Merck and is included in three NDAs. It is available from nine suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ISENTRESS profile page.

The generic ingredient in ISENTRESS is raltegravir potassium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

Summary for 205786

Tradename:	ISENTRESS
Applicant:	Msd Sub Merck
Ingredient:	raltegravir potassium
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205786

Generic Entry Date for 205786^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe Dosage: POWDER;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: 205786

Mechanism of Action	HIV Integrase Inhibitors

Medical Subject Heading (MeSH) Categories for 205786

Anti-HIV Agents
HIV Integrase Inhibitors

Suppliers and Packaging for NDA: 205786

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISENTRESS	raltegravir potassium	POWDER;ORAL	205786	NDA	Merck Sharp & Dohme LLC	0006-3603	0006-3603-60	60 PACKET in 1 CARTON (0006-3603-60) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)
ISENTRESS	raltegravir potassium	POWDER;ORAL	205786	NDA	Merck Sharp & Dohme LLC	0006-3603	0006-3603-61	60 PACKET in 1 CARTON (0006-3603-61) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 100MG BASE/PACKET
Approval Date:	Dec 20, 2013	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Apr 3, 2024	Product Flag?		Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Sep 11, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 205786

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013	⤷ Subscribe	⤷ Subscribe
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013	⤷ Subscribe	⤷ Subscribe
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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