Details for New Drug Application (NDA): 212161

NDA 212161 describes VYNDAMAX, which is a drug marketed by Foldrx Pharms 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 VYNDAMAX profile page.

The generic ingredient in VYNDAMAX is tafamidis. One supplier is listed for this compound. Additional details are available on the tafamidis profile page.

Summary for 212161

Tradename:	VYNDAMAX
Applicant:	Foldrx Pharms
Ingredient:	tafamidis
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 212161

Dosage:

CAPSULE;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.

Suppliers and Packaging for NDA: 212161

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VYNDAMAX	tafamidis	CAPSULE;ORAL	212161	NDA	Pfizer Laboratories Div Pfizer Inc	0069-8730	0069-8730-30	30 BLISTER PACK in 1 CARTON (0069-8730-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-8730-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	61MG
Approval Date:	May 3, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 3, 2024
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	May 3, 2026
Regulatory Exclusivity Use:	TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION
Patent:		Patent Expiration:	Dec 19, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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