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Generated: September 19, 2018

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Details for New Drug Application (NDA): 203188

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NDA 203188 describes KALYDECO, which is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the KALYDECO profile page.

The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.
Summary for 203188
Tradename:KALYDECO
Applicant:Vertex Pharms
Ingredient:ivacaftor
Patents:7
Generic Entry Opportunity Date for 203188
Generic Entry Date for 203188*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 203188
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KALYDECO ivacaftor TABLET;ORAL 203188 NDA Vertex Pharmaceuticals Incorporated 51167-200 51167-200-01 4 BLISTER PACK in 1 CARTON (51167-200-01) > 14 TABLET, FILM COATED in 1 BLISTER PACK
KALYDECO ivacaftor TABLET;ORAL 203188 NDA Vertex Pharmaceuticals Incorporated 51167-200 51167-200-02 1 BOTTLE in 1 CARTON (51167-200-02) > 60 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 31, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 31, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Aug 15, 2025
Regulatory Exclusivity Use:THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
Regulatory Exclusivity Expiration:Jul 31, 2024
Regulatory Exclusivity Use:TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, AND 3849+10KBC-T

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