Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211996

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NDA 211996 describes VYNDAQEL, which is a drug marketed by Foldrx Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the VYNDAQEL profile page.

The generic ingredient in VYNDAQEL is tafamidis meglumine. One supplier is listed for this compound. Additional details are available on the tafamidis meglumine profile page.
Summary for 211996
Tradename:VYNDAQEL
Applicant:Foldrx Pharms
Ingredient:tafamidis meglumine
Patents:4
Generic Entry Opportunity Date for 211996
Generic Entry Date for 211996*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION
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: 211996
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996 NDA Pfizer Laboratories Div Pfizer Inc 0069-1975 0069-1975-40 4 CARTON in 1 CARTON (0069-1975-40) > 30 BLISTER PACK in 1 CARTON > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-1975-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
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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