Details for New Drug Application (NDA): 210807

NDA 210807 describes DELSTRIGO, which is a drug marketed by Msd Merck Co and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DELSTRIGO profile page.

The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. One supplier is listed for this compound. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.

Summary for 210807

Tradename:	DELSTRIGO
Applicant:	Msd Merck Co
Ingredient:	doravirine; lamivudine; tenofovir disoproxil fumarate
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210807

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: 210807

Mechanism of Action

Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 210807

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807	NDA	Merck Sharp & Dohme LLC	0006-5007	0006-5007-01	30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG;300MG;300MG
Approval Date:	Aug 30, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 27, 2025
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:		Patent Expiration:	Nov 29, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Nov 29, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

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