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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212161

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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
Generic Entry Opportunity Date for 212161
Generic Entry Date for 212161*:
Constraining patent/regulatory exclusivity:
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:RXDosage:CAPSULE;ORALStrength61MG
Approval Date:May 3, 2019TE: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:  Start TrialPatent Expiration:Apr 27, 2024Product Flag?YSubstance Flag?YDelist Request?

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