Details for New Drug Application (NDA): 216964

NDA 216964 describes IDVYNSO, which is a drug marketed by MSD and is included in one NDA. It is available from one supplier. Additional details are available on the IDVYNSO profile page.

The generic ingredient in IDVYNSO is doravirine; islatravir. One supplier is listed for this compound. Additional details are available on the doravirine; islatravir profile page.

Summary for 216964

Tradename:	IDVYNSO
Applicant:	Msd
Ingredient:	doravirine; islatravir
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 216964

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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: 216964

Mechanism of Action

Non-Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 216964

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IDVYNSO	doravirine; islatravir	TABLET;ORAL	216964	NDA	Merck Sharp & Dohme LLC	0006-5092	0006-5092-01	30 TABLET, FILM COATED in 1 BOTTLE (0006-5092-01)
IDVYNSO	doravirine; islatravir	TABLET;ORAL	216964	NDA	Merck Sharp & Dohme LLC	0006-5092	0006-5092-59	14 TABLET, FILM COATED in 1 BOTTLE (0006-5092-59)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG;0.25MG
Approval Date:	Apr 20, 2026	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 20, 2031
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY

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